USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time

Formosa Pharmaceuticals and AimMax Therapeutics announce NDA Submission to USFDA for APP13007

APP13007 is a novel aqueous nanosuspension formulation for the treatment of inflammation and pain following ocular surgery

Wacker acquires Spain-based biotech firm ADL BioPharma

The acquisition of ADL BioPharma now makes WACKER owner of the entire plant, with total fermentation capacities of just under 3,000 cubic meters

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation

Zydus receives final approval from the USFDA for Sucralfate Tablets USP, 1 gram

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.

Astec LifeSciences appoints K. Suryanarayan as Chief Financial Officer

He has over two decades of leadership experience as an innovative strategic planner in finance diligence

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients