The antibiotic can no longer be used in moderate acne vulgaris, eradication of Helicobacter pylori, and prevention of ...

On 21 May 2024, the European Medicines Agency (“EMA”) published a revised version of the Questions & Answers for applicants, Marketing Authorisation Holders of medicinal products and notified ...

In 2021, the FDA and EMA launched a parallel scientific advice pilot program for complex generic/hybrid drug products. This program aims to provide a mechanism for the FDA and EMA to jointly ...

The European Medicines Agency (EMA) has designated allopurinol as the first orphan drug for the treatment of Marfan syndrome, ...

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Autolus Therapeutics' autologous CD19-directed CAR T-cell therapy Aucatzyl ...

AstraZeneca (NASDAQ:AZN) announced Tuesday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed its anti-PD-L1 immunotherapy Imfinzi as part of a combination ...

Bayer announces EMA committee recommends label extension approval for Eylea 8 mg: Berlin Monday, May 26, 2025, 17:00 Hrs [IST] Bayer announced that the Committee for Medicinal Pro ...

today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated ...

has been under review by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use for the same indication since the agency validated its marketing authorization ...