Medscape

EMA Tightens Liver Safety Rules for Epilepsy Drug

Severe liver injury cases prompt required liver function testing for patients taking the epilepsy drug as adjunctive therapy for focal seizures.
Regulatory Affairs Professionals Society

Euro Roundup: EMA finalizes reflection paper on biosimilar comparative efficacy studies

The European Medicines Agency has finalized its reflection paper on a tailored clinical approach to biosimilar development, ...

European Commission Approves KEYTRUDA® (pembrolizumab) Plus Paclitaxel ± Bevacizumab for the Treatment of Adults With PD-L1 (CPS ≥1) Platinum-Resistant R…

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA® (pembrolizumab), in ...
Pharmabiz

EMA recommends marketing authorisation in EU for Imdylltra to treat adults with extensive-stage small cell lung cancer

EMA recommends marketing authorisation in EU for Imdylltra to treat adults with extensive-stage small cell lung cancer: Amsterdam, The Netherlands Monday, March 30, 2026, 17:00 Hr ...
Medscape

EMA OKs Oral Treatment for Postnatal Depression

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has adopted a positive opinion on zuranolone (Zurzuvae, Biogen Netherlands BV), the first oral drug to treat ...
The Pharma Letter

Keytruda regimen wins EU nod in PD-L1-positive platinum-resistant ovarian cancer

Merck & Co’s Keytruda (pembrolizumab)—in combination with paclitaxel, with or without bevacizumab—has been approved in the ...
Seeking Alpha

OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation Eligibility

New York, New York--(Newsfile Corp. - December 5, 2025) - OS Therapies Inc. (OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced the ...

Teva receives FDA approval for Prolia biosimilar

Teva Pharmaceutical has announced the US Food and Drug Administration (FDA) approval for Ponlimsi (denosumab-adet) as a ...