The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

Johnson & Johnson JNJ announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use ...

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

MALVERN, Pa. - Ocugen, Inc. (NASDAQ: NASDAQ:OCGN), a biotechnology company with a current market capitalization of $212 million, announced today that the European Commission has endorsed the European ...

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 committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.

Ocugen (OCGN) announced that the European Commission has provided a positive opinion from the EMA’s, or European Medicines Agency’s, Committee ...

The committee recommended the new formulation in two EGFR-mutated advanced NSCLC settings, for which intravenous Rybrevant is already available.

Merck on Friday said the recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use covers the 21-valent conjugate vaccine for immunization for the prevention ...

Drug major Merck & Co. (MRK) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or ...

U.S. President Donald Trump said trade tariffs would be imposed on the European Union and U.K., but he signaled that a deal ...

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.