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2049 News Found

FDA delays Corcept’s hypertension drug, seeks more evidence
Drug Approval | January 05, 2026

FDA delays Corcept’s hypertension drug, seeks more evidence

The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence


FDA flags uncertainty over PFAS in cosmetics, calls for more research
News | January 05, 2026

FDA flags uncertainty over PFAS in cosmetics, calls for more research

Our scientists found that toxicological data for most PFAS are incomplete or unavailable, leaving significant uncertainty about consumer safety


FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA
Drug Approval | January 05, 2026

FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA

The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement


FDA nod to first new motion sickness drug in 40 years
Clinical Trials | January 04, 2026

FDA nod to first new motion sickness drug in 40 years

The approval is supported by data from three pivotal clinical trials


FibroBiologics moves experimental psoriasis therapy into FDA review
News | January 04, 2026

FibroBiologics moves experimental psoriasis therapy into FDA review

The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline


Indian Pharmacopoeia 2026 debuts with 121 new monographs targeting TB, diabetes, and cancer
News | January 04, 2026

Indian Pharmacopoeia 2026 debuts with 121 new monographs targeting TB, diabetes, and cancer

Coverage has been significantly strengthened across key therapeutic categories, including anti-tubercular, anti-diabetic and anti-cancer medicines, as well as iron supplements, thereby ensuring more comprehensive standardisation of medicines used under various National Health Programmes


Ultragenyx’s Setrusumab falls short in Phase 3 osteogenesis imperfecta trials
Clinical Trials | January 01, 2026

Ultragenyx’s Setrusumab falls short in Phase 3 osteogenesis imperfecta trials

The trials did not show a statistically significant reduction in annualized clinical fracture rates compared to placebo or bisphosphonates


Establishment Labs seeks FDA nod for Motiva breast reconstruction implants
News | January 01, 2026

Establishment Labs seeks FDA nod for Motiva breast reconstruction implants

Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation


Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency
News | January 01, 2026

Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency

The accelerated review covers WCK 5222 for multiple critical infections


HUTCHMED’s Fanregratinib gains priority review in China for aggressive liver cancer
News | January 01, 2026

HUTCHMED’s Fanregratinib gains priority review in China for aggressive liver cancer

ICC is a highly aggressive liver cancer arising from the intrahepatic biliary epithelium