The CHMP of the European Medicines Agency based its positive opinion on ... with the known profile of this medicine. Imfinzi is approved in the US and several other countries in this setting.

Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United Kingdom (UK) Medicines and Healthcare ...

Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that its prostate cancer PET[1] imaging agent Illuccix® ...

With the thumbs up from CHMP, the Opvido-Yervoy combo now moves forward to the European ... The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Winrevair in ...

Bristol Myers on Friday said the European Medicines Agency's Committee for Medicinal ... Breyanzi is already approved in several lymphoma indications in Europe. The Princeton, N.J ...

With that said, there are currently only about 3 approved treatments to help ... there is no assurance that the European Medicines Agency is going to ultimately grant marketing approval for ...

The FDA in 2023 gave an initial green light to Leqembi, which is now approved in several other countries and in November won a positive opinion from the European Medicines Agency's Committee for ...

setting itself up for the ability to file a Biologics License Application [BLA] and Marketing Authorization Application [MAA] to the FDA and European Medicines Agency [EMA] respectively.

AEON Biopharma, Inc. (NYSE: AEON) (the “Company”), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351 (k) biosimilar pathway, today announced that ...

The FDA approved five fewer novel medicines than in 2023 while the EMA improved its tally by seven. Image credit: Shutterstock / Tamakhin Mykhailo. The US Food and Drug Administration (FDA) has ...

Ocugen, Inc. (NASDAQ: OCGN) has reached a significant milestone in the development of its gene-agnostic therapy, OCU400, as the European Commission has delivered a positive opinion designating it ...