Clinical Development, FDA Approval and Research Laboratories

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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 Therapies Treatment

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.

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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

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. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. Retevmo is an U.S.

Research

Research Treatment Therapies Trials

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

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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 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

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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

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

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.

Therapies

Therapies Treatment Trials FDA

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

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 FDA Approval

Drug Discovery Digest

FDA Approves

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

Trending Sources

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

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

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

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

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

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

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

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

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