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 ...

GBP/USD halts its three-day winning streak, trading around 1.2490 during the Asian hours on Thursday. The Pound Sterling ...

The biologics drug substance manufacturing market is witnessing substantial expansion, largely due to the growing prevalence of chronic diseases, which is driving the need for biologics development ...

Valneva’s chikungunya vaccine Ixchiq has been greenlit by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) ...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as Hetronifly® in Europe), has been officially approved by the European Commission (EC) ...

Berlin: Bayer has announced the submission of a marketing authorization application to the European Medicines Agency (EMA), ...

Telethon Foundation is seeking approval for a gene therapy to treat the rare disease Wiskott-Aldrich syndrome.

President Trump agreed to a 30-day pause in return for concessions on border and crime enforcement with the two neighboring ...

Bayer seeks European marketing approval for use of finerenone in adult patients with HF with a left ventricular ejection fraction (LVEF) of =40%: Berlin Tuesday, February 4, 2025, ...

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, ...