Clinical Development, FDA Approval and Laboratories

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

The Pharma Data

JULY 2, 2025

“This priority review designation reflects the transformative potential of WINREVAIR for patients living with PAH,” said Dr. Joerg Koglin , Senior Vice President of Global Clinical Development at Merck Research Laboratories. WINREVAIR is the first FDA-approved activin signaling inhibitor for PAH.

Trials

Trials FDA Licensing Licensing

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.

FDA Approval

FDA Approval Treatment FDA Therapies

FDA Approves

The Pharma Data

JUNE 2, 2023

Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S., For the U.S.

FDA Approval

FDA Approval FDA Treatment Therapies

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

The Pharma Data

AUGUST 31, 2021

10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response.

FDA Approval

FDA Approval Treatment FDA Research Laboratories

FDA approves Phase 1 trial for HIV gene therapy

The Pharma Data

AUGUST 24, 2020

The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases.

FDA Approval

FDA Approval Therapies Trials FDA

U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients

The Pharma Data

JUNE 7, 2023

FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Source link: [link]

FDA Approval

FDA Approval FDA Disease Research Laboratories

The Power of AI in Drug Discovery and Development

The Connected Lab

APRIL 8, 2020

For patients suffering from an illness with no approved treatment, the wait can be unnerving. To this day, more than 400 million people suffer from rare diseases and 95% of rare diseases lack an FDA approved treatment 3. Thermo Fisher Scientific is at the forefront for enabling centralized data management for laboratories.

Pharma Companies

Pharma Companies Laboratories Drugs FDA Approval

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

Drugs developed under the Fast Track program are afforded increased access to FDA staff and may qualify for other programs to further expedite their clinical development, such as priority review and accelerated approval. Brilacidin antiviral research to date has been limited to laboratory-based experiments.

Clinical Trials

Clinical Trials Trials Treatment Pharmaceuticals

Adagrasib

New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

FDA

FDA Clinical Trials FDA Approval Treatment

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 The most common Grade 3 or 4 laboratory abnormalities (?2%)

Treatment

Treatment FDA Approval Pharmacokinetics FDA

Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma

The Pharma Data

JUNE 26, 2021

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Current clinical development programs include Libtayo in combination with chemotherapy for advanced NSCLC irrespective of PD-L1 expression and Libtayo monotherapy for advanced cervical cancer.

Trials

Trials Treatment Therapies Disease

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

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals

Hospitals Production Clinical Trials Virus

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

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

Hospitals

Hospitals Virus Production Clinical Trials

Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

The Pharma Data

APRIL 11, 2021

FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ?50 i Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Laboratory abnormalities (all grades; Grade 3-4) ?20% Retevmo is an U.S. SE HCP ISI All_25MAR2021.

Research

Research Treatment Therapies Trials

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

Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 Senior Vice President and Head of Global Clinical Development at Regeneron.

Virus

Virus Trials Clinical Trials Production

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

Production

Production Trials Treatment Disease

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. LABORATORY ABNORMALITIES.

FDA Approval

FDA Approval FDA Clinical Trials Disease

FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

The Pharma Data

NOVEMBER 22, 2020

The FDA approved it under the brand name Gavreto on September 4. There is a real need to advance new treatment options for triple-negative breast cancer, an aggressive form of the disease,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in July 2020.

FDA

FDA Licensing Licensing Treatment

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

The Pharma Data

MARCH 23, 2021

“There have been few advances in improving survival outcomes in the first-line treatment setting for esophageal cancer over the last three decades,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We 1] as determined by an FDA-approved test.

Treatment

Treatment FDA Approval FDA Therapies

Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer

The Pharma Data

APRIL 28, 2023

Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), by a vote of 11 to 1 with one abstention, supported FDA approval of LYNPARZA plus abiraterone and prednisone or prednisolone (abi/pred) for the first-line treatment of adult patients with BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC).

FDA

FDA FDA Approval Trials Treatment

FDA accepts Dupixent® (dupilumab) for priority review in adults with prurigo nodularis

The Pharma Data

MAY 31, 2022

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings outside of the US are also planned in 2022.

FDA

FDA Disease Trials FDA Approval

FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

The Pharma Data

APRIL 4, 2022

The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

FDA

FDA Treatment Disease FDA Approval

Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ?50% PD-L1 expression

The Pharma Data

JUNE 26, 2021

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Current clinical development programs include Libtayo in combination with chemotherapy for advanced NSCLC irrespective of PD-L1 expression and Libtayo monotherapy for advanced cervical cancer.

Treatment

Treatment Trials Disease FDA Approval

Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

The Pharma Data

JULY 15, 2021

“These highly anticipated event-free survival results in this TNBC population build upon earlier findings from the KEYNOTE-522 trial and further support the potential use of KEYTRUDA in these patients,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. 10) as determined by an FDA-approved test.

Therapies

Therapies Treatment Trials FDA

XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

The Pharma Data

JUNE 26, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring blood clots with standard anticoagulant therapy, which often requires painful injections, dietary restrictions and regular laboratory monitoring.

Doctors

Doctors Hospitals Treatment Clinical Trials

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: Moderna, Inc. . Posted: November 2020. Source link.

Vaccine

Vaccine FDA Clinical Trials Disease

Regeneron Reports Third Quarter 2020 Financial and Operating Results

The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Updates from the clinical pipeline include: Dupixent ® (dupilumab). Regeneron Pharmaceuticals, Inc. Business Highlights.

Production

Production Trials FDA FDA Approval

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. All patients entering the trial were hospitalized with laboratory-confirmed COVID-19 requiring low-flow oxygen, and all received other background standard-of-care as required. Casirivimab and imdevimab injection is not FDA approved for any use.

Hospitals

Hospitals Trials Clinical Trials Production

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

The Pharma Data

JANUARY 15, 2021

mg/kg) is also approved in the U.S. About the Enhertu Clinical Development Program. A comprehensive development program is underway globally with nine pivotal trials evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers including breast, gastric and lung cancers. Enhertu (6.4

Treatment

Treatment Trials Disease Therapies

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

The Pharma Data

APRIL 4, 2023

This expands the use of KEYTRUDA-based regimens to more patients with advanced urothelial carcinoma and demonstrates the value of collaboration in creating new combination approaches for patients in need of more options.”

Treatment

Treatment FDA Approval FDA Therapies

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

FDA Approval

FDA Approval FDA Hospitals Treatment

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.

Vaccine

Vaccine Trials Treatment Virus

Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes

The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) approved VAXNEUVANCE ™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.

Disease

Disease Immune Response Vaccine FDA Approval

LYNPARZA® (olaparib) in Patients with Metastatic Castration-Resistant Prostate Cancer to Stop for Futility

The Pharma Data

MARCH 15, 2022

“There remains a significant unmet need for patients diagnosed with advanced prostate cancer, who have a poor prognosis after not responding to initial therapy,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Merck’s Focus on Cancer.

DNA

DNA Clinical Trials Trials Therapies

VERQUVO® (vericiguat) Approved in the European Union

The Pharma Data

JULY 21, 2021

Bayer also issued a news release earlier today announcing the EC approval. Food and Drug Administration (FDA) approved VERQUVO in the U.S. Merck has the commercial rights to VERQUVO in the United States and Bayer has the exclusive commercial rights in the rest of world. In January of this year, the U.S.

Treatment

Treatment Production Disease Hospitals

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

The Pharma Data

OCTOBER 29, 2020

“Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients,” said Brett King , MD, PhD associate professor of Dermatology at Yale School of Medicine. patients with a history of diverticulitis).

Therapies

Therapies Treatment Disease Clinical Trials

Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial

The Pharma Data

MARCH 4, 2021

This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s).

Trials

Trials Treatment Therapies Clinical Trials

XELJANZ® (TOFACITINIB CITRATE) RECEIVES MARKETING AUTHORIZATION IN THE EUROPEAN UNION.

The Pharma Data

AUGUST 22, 2021

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012. FDA-APPROVED INDICATIONS. LABORATORY ABNORMALITIES. Rheumatoid Arthritis.

Marketing

Marketing Clinical Trials Treatment Therapies

Vimseltinib

New Drug Approvals

APRIL 8, 2025

Vimseltinib 1628606-05-2 DCC-3014 2/14/2025 FDA APPROVED, Romvimza 3-methyl-5-[6-methyl-5-[2-(1-methylpyrazol-4-yl)pyridin-4-yl]oxypyridin-2-yl]-2-(propan-2-ylamino)pyrimidin-4-one C 23 H 25 N 7 O 2 , 431.5 2] Vimseltinib was approved for medical use in the United States in February 2025. [2] Food and Drug Administration (FDA).

FDA Approval

FDA Approval FDA Clinical Development Treatment

AI at the forefront of age-related disease treatment

Drug Target Review

MAY 19, 2025

It also allows us to identify drug combinations that target multiple ageing pathways simultaneously and that have been deemed safe in the clinic previously. This does not only derisk clinical development but increases clinical success.

Disease

Disease Treatment Therapies Drug Development

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

Trending Sources

FDA Approves

FDA Approves Updated Indication for Merck’s KEYTRUDA® (pembrolizumab) for Treatment.

FDA approves Phase 1 trial for HIV gene therapy

U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients

The Power of AI in Drug Discovery and Development

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

Adagrasib

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Libtayo® (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma

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

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

Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

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

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

FDA Action Alert: Blueprint, Liquidia, Revance, Rhythm and Merck

First Anti-PD-1 in Combination With Chemotherapy Approved for the First-Line Treatment of Esophageal and GEJ Carcinoma, Regardless of Histology or PD-L1 Expression

Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer

FDA accepts Dupixent® (dupilumab) for priority review in adults with prurigo nodularis

FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

Libtayo® (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ?50% PD-L1 expression

Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization

Regeneron Reports Third Quarter 2020 Financial and Operating Results

Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

Enhertu Approved in the U.S. for the Treatment of Patients With Previously Treated HER2 Positive Advanced Gastric Cancer

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination With Padcev® (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction

Transgene Announces Detailed Results From Clinical Study of TG4001 in Combination With Avelumab in Advanced HPV-positive Cancers

Prevention of Invasive Pneumococcal Disease in Adults 18 Years and Older Caused by 15 Serotypes

LYNPARZA® (olaparib) in Patients with Metastatic Castration-Resistant Prostate Cancer to Stop for Futility

VERQUVO® (vericiguat) Approved in the European Union

Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata

Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial

XELJANZ® (TOFACITINIB CITRATE) RECEIVES MARKETING AUTHORIZATION IN THE EUROPEAN UNION.

Vimseltinib

AI at the forefront of age-related disease treatment

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