Merck and AstraZeneca updates on US regulatory review of Lynparza for mCRPC

AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.

Strides flagship facility in Bangalore receives USFDA inspection closure

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma

Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940

Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency

Astellas updates on Fezolinetant application in US

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients

USFDA accepts for priority review the sNDA for Merck’s Prevymis

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients

Pfizer announces Talzenna and Xtandi combination data from phase 3 study

Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI