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FDA Approves Merck’s ENFLONSIA™ to Prevent RSV in Infants

The Pharma Data

JUNE 9, 2025

FDA Approves Merck’s ENFLONSIA™ to Protect Infants from Severe RSV Illness Merck operating as MSD outside the United States and Canada, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for ENFLONSIA™ (clesrovimab-cfor).

FDA Approval

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Automated red blood cell exchange: bridging treatment gaps in sickle cell disease care

Drug Target Review

JUNE 5, 2025

Despite recent advances in gene therapy for sickle cell disease (SCD) , automated red blood cell exchange (aRBCX) remains a cornerstone therapy that plays a vital yet underutilised role in managing complications and enhancing quality of life for millions living with this devastating condition worldwide.

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Q&A: One scientist’s bold vision to make on-demand treatments routine for life-threatening rare genetic diseases

Broad Institute

JUNE 24, 2025

Based on a technology developed by Broad Institute core member David Liu’s laboratory, the treatment is the first in a series of new medicines being tested to treat rare diseases by repairing patients’ particular genetic misspellings. s to be produced at scale, making them the standard of care for life-threatening rare genetic diseases.

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Study finds biomarkers, drug targets, risk factors for most common form of lung cancer

Broad Institute

JULY 31, 2025

Lung cancer atlas Despite new targeted therapies for lung cancer over the last two decades, lung adenocarcinoma still kills the majority of patients, including many who have never smoked, suggesting the need for a deeper look at the disease.& & Paper cited: Satpathy S et al. Cancer Cell. Online July 31, 2025.

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FDA Grants Accelerated Approval to Lynozyfic™ for Relapsed or Refractory Multiple Myeloma

The Pharma Data

JULY 2, 2025

Continued approval will hinge on confirmatory data from a Phase 3 study that validates long-term clinical benefits. A New Class of Bispecific Antibody Therapy Lynozyfic is the first FDA-approved bispecific antibody that targets B-cell maturation antigen (BCMA) and CD3, enabling T-cell mediated killing of multiple myeloma cells.

FDA

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FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

The Pharma Data

JULY 2, 2025

This trial was the first in its therapeutic area to use a composite primary endpoint consisting solely of major morbidity and mortality events , such as all-cause death, lung transplantation, or PAH-related hospitalization of at least 24 hours. WINREVAIR is the first FDA-approved activin signaling inhibitor for PAH.

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FDA Approves KEYTRUDA for Neoadjuvant and Adjuvant Treatment of PD-L1+ Resectable Head & Neck Cancer

The Pharma Data

JUNE 13, 2025

FDA Approves KEYTRUDA® (Pembrolizumab) for Perioperative Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma Merck known as MSD outside the United States and Canada, recently announced that the U.S. 0.89; p = 0.00140).

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University Hospitals now offering FDA-approved medication for treatment of Alzheimer’s disease

SCIENMAG: Medicine & Health

FEBRUARY 9, 2024

CLEVELAND—University Hospitals (UH) Brain Health & Memory Center is now treating patients with LEQEMBI® (lecanemab), a Food and Drug Administration-approved medication for the treatment of Alzheimer’s disease.

Hospitals

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FDA Approves Veklury (remdesivir) for the Treatment of COVID-19

The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. FOSTER CITY, Calif.–(BUSINESS –(BUSINESS WIRE)–Oct.

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FDA Approves Pfizer Med for Rare Form of Pediatric Non-Hodgkin Lymphoma

The Pharma Data

JANUARY 14, 2021

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock. Most Read Today.

FDA Approval

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Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland

The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer. Gilead Sciences, Inc. Source link: [link].

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Gilead applies for FDA approval to treat coronavirus patients with remdesivir

The Pharma Data

AUGUST 11, 2020

It has not received general approval to treat the virus in the US, but has in several European countries and Japan. The request for approval comes nearly two months after a study from the National Institute of Allergy and Infectious Diseases which showed positive results, with the drug effectively blocking the virus from replicating.

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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

DECEMBER 17, 2020

(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. Casirivimab and imdevimab injection is not FDA approved for any use.

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FDA Approves Myovant Drug as First-Ever Oral Hormone Therapy for Prostate Cancer

The Pharma Data

DECEMBER 21, 2020

Food and Drug Administration (FDA) has now approved the very first oral drug to treat the millions of men affected. . Now, all that being said, with the Covid-19 pandemic, there is a recommendation from the National Comprehensive Cancer Network for patients with cancer to avoid hospitals and clinics as much as possible.

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Radius Health, Inc. Announces Acquisition of Orphan Disease Program

The Pharma Data

JANUARY 5, 2021

RAD011 is a pivotal-trial ready synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases. Prader-Willi syndrome (“PWS”) will be the initial indication, which has been granted Orphan Drug and Fast Track Designation by the FDA. Disease Highlights.

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Lupus Foundation of America Sees Big Win with FDA Approval of Benlysta for Lupus Nephritis

The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations. Lupus is an unpredictable and misunderstood autoimmune disease that ravages different parts of the body.

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BioCryst Announces FDA Approval of ORLADEYO, First Therapy to Prevent HAE Attacks in Adults

The Pharma Data

DECEMBER 3, 2020

The addition of berotralstat through the EAMS will bring a much needed option for HAE patients suffering with this debilitating disease,” said Dr. Sorena Kiani, Consultant Immunologist at Royal London Hospital, London. “There are many patients in the UK that don’t have a realistic option for effective HAE prophylaxis.

FDA Approval

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New Hope Against Diseases Marked by Progressive Scarring of Lung Tissue

The Pharma Data

JANUARY 15, 2021

13 in the New England Journal of Medicine , involved patients with high blood pressure in the lungs caused by interstitial lung disease (ILD). It can have a range of causes, from smoking, to occupational exposure to toxins like asbestos, as well as autoimmune diseases like rheumatoid arthritis. The study, published online Jan.

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

JULY 8, 2021

ADUHELM should be initiated in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. Food and Drug Administration (FDA) has approved an updated label for ADUHELM (aducanumab-avwa) injection 100 mg/mL solution. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

The Pharma Data

JULY 23, 2021

Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”

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FDA approves Roche’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)

The Pharma Data

MAY 31, 2022

. “The approval of Evrysdi for pre-symptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” said Richard Finkel, M.D., Jude Children’s Research Hospital. There were no treatment-related adverse events leading to withdrawal.

FDA Approval

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REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

The Pharma Data

OCTOBER 30, 2020

(NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified. About the REGN-COV2 Trial in Hospitalized Patients. Cohort 1A: patients not requiring oxygen.

Hospitals

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Shifting Paradigms in PAH Clinical Trials: 7 Key Takeaways for Success

PPD

AUGUST 5, 2024

Pulmonary arterial hypertension (PAH) is a progressive and fatal lung disease that is caused or influenced by multiple factors. Composite endpoints might include factors such as hospitalization, transplantation and worsening of clinical outcomes. Historically, the available drugs and U.S. None offers a cure for PAH.

Clinical Trials

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Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Food and Drug Administration (FDA)-approved for this use and there is limited information known about the safety or effectiveness of using Actemra/RoActemra to treat people in the hospital with COVID-19.

Treatment

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SQI Diagnostics Updates Clinical Progress on Novel COVID-19 Tests Under Development for U.S. FDA Regulatory Submission

The Pharma Data

OCTOBER 25, 2020

.” SQI’s RALI-dx COVID-19 Severity Triage Test measures five critical biomarkers including IL-6 in approximately 50-minutes to help clinicians determine severe inflammatory response in patients with COVID-19 and whether they require hospital admission or not. SQI Diagnostics, Inc.

FDA

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FDA: Remdesivir (Veklury) Approval for the Treatment of COVID-19 – The Evidence for Safety and Efficacy

The Pharma Data

NOVEMBER 25, 2020

November 25, 2020 — Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard.

FDA

FDA Treatment Clinical Trials Hospitals

How Digital Therapeutics are Shaping the Pharmaceutical Industry

DrugBank

DECEMBER 18, 2024

These interventions target a broad spectrum of medical conditions, encompassing chronic diseases and even substance abuse. However, non-adherence to medication regimens remains a pervasive problem, leading to suboptimal outcomes and increased hospitalizations.

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Pharmaceuticals Pharmaceutical Companies Treatment Hospitals

The Year in AdComms – A Look Back at 2023

Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Does this signal a return in 2024 to in-person meetings? ” Volume of Meetings and Outcomes.

FDA

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Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

The Pharma Data

NOVEMBER 16, 2020

and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. principal investigator of the NIAID-funded Infectious Diseases Clinical Research Consortium site at Baylor College of Medicine in Houston; Lindsey R. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History.

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Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

The Pharma Data

FEBRUARY 23, 2022

. * In the VAT08 Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated: * 100% efficacy against severe COVID-19 disease and hospitalizations * 75% efficacy against moderate or severe COVID-19 disease * 57.9% Geometric Mean Titers (GMT) (95% CI).

Vaccine

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Data Presented at TCT Connect Finds Pre-PCI Use of Impella for AMI Cardiogenic Shock is Associated with Higher Survival, Particularly in Women

The Pharma Data

OCTOBER 15, 2020

John Hospital, researchers compared 649 patients from two cohorts: a recent cohort (2017–2019) from the RECOVER III post-market approval (PMA) study, after the widespread adoption of the best practice of placing Impella pre-PCI, and a cohort from before PMA (2008–2014) when the practice of placing Impella pre-PCI was not yet widely adopted.

Hospitals

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Announcing the first biopharma IPNFT Transaction

Molecule Blog

AUGUST 13, 2021

v=uT2-0qoHjbc Who will be there: Molecule & VitaDAO Core Teams If you haven’t yet read up on the research project as well as the researchers behind it, find more about it below: About the Research Project What if therapeutics to slow down the ageing process and prevent age-related disease already existed? billion prescriptions from 4.8

FDA Approval

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Advancing CAR-T therapy: how CD5 modulation is shaping cancer treatment

Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

Therapies

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FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma

The Pharma Data

MARCH 4, 2021

They are also at risk for life-threatening severe asthma attacks that can lead to hospitalization and emergency room visits, and may require the use of systemic corticosteroids which carry significant risks when used long term. Dupixent is approved in the U.S. Outside of the U.S.,

FDA

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FDA Action Alert: Y-mAbs, Vanda, Alnylam and BioCryst

The Pharma Data

NOVEMBER 29, 2020

The FDA approved the drug on November 24. PH1 is an ultra-rare genetic disease marked by overproduction of oxalate, which causes deposits of calcium oxalate crystals in the kidneys and urinary tract and can lead to painful and recurrent kidney stones, nephrocalcinosis, progression to kidney failure, and system organ dysfunction.

FDA

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Another Milestone in the Cystic Fibrosis Journey

NIH Director's Blog: Drug Development

JULY 20, 2017

Credit: Brittany Mahoney As NIH Director, I often hear stories of how people with serious diseases—from arthritis to Zika infection—are benefitting from the transformational power of NIH’s investments in basic science. Caption: Two-year-old Avalyn is among the cystic fibrosis patients who may be helped by targeted drugs.

Clinical Trials

Clinical Trials Disease Small Molecule Therapies

Amgen Announces Approval Of Aimovig® (Erenumab) In Japan For The Suppression Of Onset Of Migraine Attacks In Adults

The Pharma Data

JUNE 28, 2021

Migraine is a Disabling Neurological Disease that Affects More Than 8.4 Having this treatment approved in Japan will enable us to ultimately serve more patients and help them find the right treatment for this disabling, neurological disease.” 1,7 Although approximately 8.4 became a wholly owned affiliate of Amgen Inc.

Treatment

Treatment Disease Clinical Trials Hospitals

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1?,

Clinical Trials

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PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

The Pharma Data

AUGUST 16, 2021

Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. This press release features multimedia. In the U.S.,

Vaccine

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BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI. BioXcel Therapeutics, Inc.

Treatment

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Therapeutics for ‘COVID-19 Long-Haulers’ Exploding onto the Scene as 2020 Ends

The Pharma Data

DECEMBER 23, 2020

a Miami, Florida-based clinical-stage biopharmaceutical company focused on harnessing the power of nanoparticles for the treatment of degenerative diseases, is awaiting a decision from the FDA regarding an investigational new drug (IND) application for a clinical trial of its proprietary therapeutic, Zofin, in COVID Long-haulers. .

Clinical Trials

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Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis

The Pharma Data

FEBRUARY 18, 2022

“For clinicians treating patients with this serious, chronic disease, results from the True North extension study provide an understanding of long-term therapeutic outcomes and help to identify an appropriate treatment approach for their patients with ulcerative colitis,” said Silvio Danese, M.D., About Ulcerative Colitis.

Clinical Trials

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Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly’s Pivotal Phase 3 Studies

The Pharma Data

MARCH 27, 2022

Food and Drug Administration (FDA) granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. “Whether people with alopecia areata suffer loss of all the hair on their body or bald spots and missing eyebrows or eyelashes, this autoimmune disease can be devastating. scalp hair loss, or 14.5%

Licensing

Licensing Licensing Disease FDA Approval

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

The Pharma Data

OCTOBER 28, 2020

REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). The Phase 3 portion of this trial continues in non-hospitalized patients. In total, 47% of participants were male and 53% were female. .

Virus

Virus Trials Clinical Trials Production

FDA Approves Merck’s ENFLONSIA™ to Prevent RSV in Infants

Automated red blood cell exchange: bridging treatment gaps in sickle cell disease care

Trending Sources

Q&A: One scientist’s bold vision to make on-demand treatments routine for life-threatening rare genetic diseases

Study finds biomarkers, drug targets, risk factors for most common form of lung cancer

FDA Grants Accelerated Approval to Lynozyfic™ for Relapsed or Refractory Multiple Myeloma

FDA Grants Priority Review for WINREVAIR Label Update Based on ZENITH Trial

FDA Approves KEYTRUDA for Neoadjuvant and Adjuvant Treatment of PD-L1+ Resectable Head & Neck Cancer

University Hospitals now offering FDA-approved medication for treatment of Alzheimer’s disease

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19

FDA Approves Pfizer Med for Rare Form of Pediatric Non-Hodgkin Lymphoma

Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland

Gilead applies for FDA approval to treat coronavirus patients with remdesivir

New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

FDA Approves Myovant Drug as First-Ever Oral Hormone Therapy for Prostate Cancer

Radius Health, Inc. Announces Acquisition of Orphan Disease Program

Lupus Foundation of America Sees Big Win with FDA Approval of Benlysta for Lupus Nephritis

BioCryst Announces FDA Approval of ORLADEYO, First Therapy to Prevent HAE Attacks in Adults

New Hope Against Diseases Marked by Progressive Scarring of Lung Tissue

FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

FDA approves Roche’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)

REGN-COV2 Independent Data Monitoring Committee Recommends Holding Enrollment in Hospitalized Patients with High Oxygen Requirements and Continuing Enrollment in Patients with Low or No Oxygen Requirements

Shifting Paradigms in PAH Clinical Trials: 7 Key Takeaways for Success

Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults

SQI Diagnostics Updates Clinical Progress on Novel COVID-19 Tests Under Development for U.S. FDA Regulatory Submission

FDA: Remdesivir (Veklury) Approval for the Treatment of COVID-19 – The Evidence for Safety and Efficacy

How Digital Therapeutics are Shaping the Pharmaceutical Industry

The Year in AdComms – A Look Back at 2023

Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

Data Presented at TCT Connect Finds Pre-PCI Use of Impella for AMI Cardiogenic Shock is Associated with Higher Survival, Particularly in Women

Announcing the first biopharma IPNFT Transaction

Advancing CAR-T therapy: how CD5 modulation is shaping cancer treatment

FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma

FDA Action Alert: Y-mAbs, Vanda, Alnylam and BioCryst

Another Milestone in the Cystic Fibrosis Journey

Amgen Announces Approval Of Aimovig® (Erenumab) In Japan For The Suppression Of Onset Of Migraine Attacks In Adults

Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

Therapeutics for ‘COVID-19 Long-Haulers’ Exploding onto the Scene as 2020 Ends

Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis

Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly’s Pivotal Phase 3 Studies

Regeneron’s COVID-19 Outpatient Trial Prospectively Demonstrates that REGN-COV2 Antibody Cocktail Significantly Reduced Virus Levels and Need for Further Medical Attention

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