Browsing Tag
US Food and Drug Administration
336 posts
GSK’s bepirovirsen wins FDA priority review as chronic hepatitis B strategy enters decisive phase
GSK has FDA momentum in hepatitis B. The harder question is whether bepirovirsen can turn functional cure into a real market shift.
Eli Lilly (NYSE: LLY) bets on oral GLP-1 Foundayo and retatrutide to reclaim its $1tn valuation
Eli Lilly (NYSE: LLY) launched Foundayo, the world's first oral GLP-1 for obesity, in April 2026 and reports Q1 earnings April 30. Full pipeline and risk analysis for retail investors.
Granules India (NSE: GRANULES) exits FDA audit with four observations as regulatory scrutiny intensifies
Granules India's Chantilly facility exits a routine US FDA cGMP audit with four procedural Form 483 observations and no data integrity findings. Read what it means for the GRANULES growth outlook.
Dr. Reddy’s (NSE: DRREDDY) signals dual-track U.S. growth strategy with abatacept biosimilar BLA acceptance and OTC eye-care expansion
Discover how Dr. Reddy’s FDA-accepted abatacept biosimilar and OTC eye-care launch are reshaping its U.S. growth and investor outlook.
Organon (NYSE: OGN) secures FDA approval for five-year use of NEXPLANON contraceptive implant, adding new REMS training requirement
Find out how Organon’s NEXPLANON just got FDA approval for five-year use—and what the new REMS program means for doctors and competitors.
Regulatory breakthrough: What the MHRA–FDA tie-up means for medtech approvals
Find out how the MHRA–FDA collaboration is reshaping medical device regulation, AI safety, and faster patient access across the UK and US healthcare systems.
Alembic Pharmaceuticals gains three USFDA approvals in oncology and neurology, but can these launches offset U.S. pricing pressures?
Alembic Pharmaceuticals secures USFDA approvals in oncology and neurology, but can these launches drive U.S. revenue growth? Read the full analysis.
GSK secures FDA approval for 5-in-1 meningococcal vaccine to expand protection for adolescents
GSK has received approval from the US Food and Drug Administration (FDA) for PENMENVY, a 5-in-1 meningococcal vaccine…
Biodexa Pharmaceuticals gains FDA fast track designation for eRapa, paving way for new colorectal cancer prevention strategies
Biodexa Pharmaceuticals witnessed a sharp surge in its American depositary receipts (ADRs), rising 75% to $7.13 during Monday…
Neuren Pharmaceuticals advances NNZ-2591 for Phelan-McDermid syndrome to Phase 3 clinical trial
Neuren Pharmaceuticals has secured approval from the United States Food and Drug Administration (FDA) to progress into the…