The CHMP recommends approval for JNJ's subcutaneous formulation of Rybrevant in NSCLC and AstraZeneca's Imfinzi in ...

Janssen-Cilag International NV, a Johnson & Johnson company, received European Medicines Agency's Committee for Medicinal Products ...

The European Medicines Agency’s positive opinion for ivermectin-albendazole for treating soil-transmitted helminth infections ...

Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

EU regulators have issued a positive opinion for the extension of the market authorization for subcutaneous formulation of ...

AstraZeneca (AZN) stock in focus as its partner Daiichi Sankyo (DSNKY) wins EU backing for their jointly developed breast ...

Bristol Myers on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Breyanzi for the treatment of adults with relapsed or refractory ...

Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi. The U.S. Food and Drug Administration ...

The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive ...

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms ...

The latest decision makes Sanofi's Sarclisa the first anti-CD38 therapy for transplant-ineligible patients with front-line ...