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

Ocugen (OCGN) said it has received a positive opinion from EU regulators for Advanced Therapy Medicinal Product ...

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

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the subcutaneous (SC) formulation be approved ...

AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and only immunotherapy ...

EU agencies unite to tackle azole fungicide resistance in Aspergillus fungi: Amsterdam, The Netherlands Monday, February 3, 2025, 17:00 Hrs [IST] For the first time, t ...

A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...

Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of its 21-valent pneumococcal conjugate ...

(Alliance News) - AstraZeneca PLC on Monday said Imfinzi has been recommended for approval in the EU as monotherapy for limited-stage small cell lung cancer.

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 ...

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...