Omeros Corporation (Nasdaq: OMER) today announced the recent submission of a Marketing Authorization Application (MAA) to the ...

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

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

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 ...

European CE mark approval of the entire FemBloc® system marks pivotal achievement in expanding safe, accessible and ...

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

Regulators and manufacturers advance biosimilars for aflibercept, omalizumab, and dupilumab, enhancing access to treatment in ...

The National Health Technology Assessment System (SiNATS) has contributed over the last decade to improving access to medicines, promoting the sustainability of the SNS and reducing waste, but ...

Siena: Sun Pharma European partner Philogen S.p.A has voluntarily withdrawn the application for marketing authorization to ...

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

Advert Previous studies linked the drug to a rare eye condition known as non-arteritic anterior ischemic optic neuropathy (NAION) and, for the first time, a regulator has since confirmed the side ...