Canalevia® (crofelemer delayed-release tablets), under the name Canalevia-CA1, is conditionally approved by the FDA for ...

The European Medicines Agency has begun a review of medicines to treat alcohol dependency that contain sodium oxybate, it ...

Novo Nordisk said on Monday the European drugs regulator will allow a label update for its diabetes drug Ozempic to include a ...

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...

BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

An Irish woman who headed Ireland’s medicine’s watchdog has been appointed to take over as Executive Director of the European ...

The marketing authorisation application (MAA) for Nidlegy was submitted in June 2024, but Philogen decided to withdraw it due ...

Siena: Sun Pharma European partner Philogen S.p.A has voluntarily withdrawn the application for marketing authorization to ...

GSK plc (LSE/NYSE:GSK) announced Monday that the European Medicines Agency (EMA) has accepted for review its marketing authorisation application for linerixibat, an investigational treatment for ...

The regulator's review comes after the French medicines agency raised questions about the effectiveness of a generic drug ...

A comprehensive analysis conducted by public health experts at Novartis Romania reveals that Romanian patients may wait, on ...

Novo Nordisk NVO announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has ...