Bristol Myers Squibb BMY announced that it has obtained a positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency for two of its drugs. The ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European ...

The CHMP recommends approval for JNJ's subcutaneous formulation of Rybrevant in NSCLC and AstraZeneca's Imfinzi in limited-stage small-cell lung cancer.

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

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 ...

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

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

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

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

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