New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 Randomized clinical trials have been published to compare landiolol with placebo< [21] [22] [23] diltiazem, [24] and amiodaron [25] in patients with or without heart failure. AOP Health.

FDA

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. The speed and rigor with which Veklury has been developed and approved in the U.S.

FDA Approval

PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

Clinical Trials

The Pharma Data

JANUARY 18, 2021

Biederman, Director of Cardiovascular Imaging and Cardiac MRI at Allegheny General Hospital/Allegheny Health System in Pittsburgh and an author on the groundbreaking 2017 MagnaSafe trial published in NEJM. Impulse Dynamics, based in Marlton, N.J.,

FDA Approval

The Pharma Data

OCTOBER 30, 2020

Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

FDA Approval

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Clinical Trials

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.

FDA Approval

The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

FDA Approval

The Pharma Data

APRIL 19, 2022

The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer. Once the individualized therapy is created for a patient, the cells are carefully preserved, packed and sent back to the hospital to be infused back into the patient.

FDA Approval

The Pharma Data

AUGUST 11, 2020

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. government and health care authorities around the globe to address the treatment needs of patients with COVID-19.

FDA Approval

The Pharma Data

DECEMBER 3, 2020

Food and Drug Administration (FDA) has approved ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and young patients 12 years and older. The approval was based on data from the Phase 3 APeX-2 trial, which showed that ORLADEYO could significantly reduce attacks at the 24-week mark.

FDA Approval

The Pharma Data

DECEMBER 21, 2020

The Phase III study was conducted as an open-label trial with patients receiving either an Orgovyx pill daily or injections of Abbvie’s Lupron as an injection every three months. In the trial, Myovant’s drug outperformed Abbvie’s by suppressing testosterone to castration levels in 96.7%, compared to their competitor’s 88.8%. . “We

FDA Approval

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.”

FDA Approval

The Pharma Data

NOVEMBER 16, 2020

November 16, 2020 — An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 37% of trial volunteers are from racial and ethnic minorities.

Clinical Trials

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. “The investigational cocktail is now available to indicated high-risk U.S.

Hospitals

Drug Target Review

NOVEMBER 20, 2023

A team of scientists at Mass General Brigham in the US has developed a visualisation tool combining high-speed cameras, that can detect changes happening in a billionth of a second, and FDA-approved fluorescent injections to distinguish tumour tissue from normal tissue across several cancer types.

FDA Approval

The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. 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.

Hospitals

The Pharma Data

DECEMBER 16, 2020

Last year, GSK announced positive results from a two-year clinical trial involving several hundred people with active lupus nephritis treated with Benlysta. Additional information about today’s FDA decision is available through the GSK media release. Department of Defense Medical Research Program.

FDA Approval

The Pharma Data

NOVEMBER 25, 2020

The approval of remdesivir ( Veklury ) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard. Background Randomized, controlled trials are the gold standard for evaluating the safety and effectiveness of drugs. Researchers evaluated the clinical status of subjects on Day 14.

FDA

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.

FDA Approval

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

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. About the Actemra®/RoActemra® (tocilizumab) COVID-19 Clinical Trial Programme Roche’s clinical trial programme evaluated the safety and efficacy of Actemra/RoActemra in hospitalised patients with COVID-19.

Treatment

The Pharma Data

OCTOBER 25, 2020

The Company plans to initiate a Phase 2 trial within the next several months. “We Agitation associated with delirium is commonly seen in numerous hospital settings, resulting in serious medical complications and extended hospital stays. This condition may be caused by numerous underlying pathologic processes and disease states.

Treatment

KIF1A

APRIL 25, 2024

However, we needed to wait for Susannah to finish her trial before we could submit to the FDA for Sloane’s ASO use. February 2024 – n-Lorem submitted an IND (investigational new drug) to the FDA for Sloane. March 2024 – The FDA approved the IND, and the administering doctor (Dr.

Therapies

The Pharma Data

MAY 17, 2021

. In a Viewpoint, Bishal Gyawali, MD, PhD, and colleagues at the Program on Regulation, Therapeutics and Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital suggested improving FDA’s authority to modify drug package insert for situations such as drug repurposing and de-escalation of therapy.

Research

The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * About VAT08 and VAT02 The Phase 3 trial, VAT08 is evaluating a 10µg antigen formulation of the SARS-CoV-2 adjuvanted recombinant protein-based vaccine?for

Vaccine

The Pharma Data

JANUARY 15, 2021

15, 2021 — An inhaled medication might make every day physical activity a bit easier for patients with serious scarring of the lungs, a new clinical trial finds. Right now, no medication is approved specifically for pulmonary hypertension caused by ILD, said Dr. Steven Nathan, senior researcher on the new trial.

Disease

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

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. REGN-COV2 was well tolerated in the trial. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

Virus

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.

Disease

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 is working with agencies in both the U.S.

FDA

The Pharma Data

DECEMBER 23, 2020

On December 3, the PureTech initiated a global, Phase II trial of LYT-100 (deupirfenidone) in Long COVID respiratory complications and related sequelae. The trial is ongoing in the U.S. Leronlimab is currently undergoing a Phase IIb/III trial to evaluate its efficacy and safety for patients with severe-to-critical COVID-19.

Clinical Trials

The Pharma Data

NOVEMBER 29, 2020

The submission was based on the safety and efficacy data of the pivotal Phase II trials 201 and 12-230. The FDA approved the drug on November 24. PH1 affects patients of all ages,” said Sally-Anne Hulton, consultant pediatric nephrologist, Birmingham Women’s and Children’s Hospital NHS Trust, UK.

FDA

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. Detailed results from this Phase 3 trial will be published later this year. Dupilumab development program.

FDA

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. adult participants from the Phase 1 trial of the two-dose series. This press release features multimedia. View the full release here: [link]. In the U.S.,

Vaccine

DrugBank

DECEMBER 18, 2024

However, non-adherence to medication regimens remains a pervasive problem, leading to suboptimal outcomes and increased hospitalizations. Any deviations from baseline can trigger an alert to their healthcare provider, enabling timely intervention and potentially preventing a costly hospitalization.

Pharmaceuticals

NIH Director's Blog: Drug Development

JULY 20, 2017

The first genetic mutation that causes CF was discovered by a collaborative effort between my own research lab at the University of Michigan, Ann Arbor, and colleagues at the Hospital for Sick Children in Toronto—more than 25 years ago [1]. About 30,000 Americans have CF.

Clinical Trials