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

Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...

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 ...

BIO CEO & Investor Conference Format: "IPO Class of 2024 Panel" and one-on-one meetings Date: February 10, 2025 Location: New York, NY Registered conference attendees may schedule one-on-one meetings ...

Immunotherapy has shown a 27% reduction in mortality for patients with limited-stage small cell lung cancer, based on Phase ...

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 ...

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

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

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

If authorised, Vimkunya would be the first vaccine in the EU to protect adolescents aged 12 to 17 against Chikungunya.