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

EMA's CHMP has recommended AstraZeneca's Imfinzi for approval in the EU as a single agent for limited-stage small cell lung ...

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

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

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

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

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 ...

Europeans are being warned of the dangers of counterfeit medications after police squads across the continent reported ...

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, ...