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

Integral Molecular, a leader in antibody discovery technologies, is proud to announce that the FDA has accepted their ...

Medicenna Therapeutics Corp. ("Medicenna” or the "Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy co ...

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

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, ...

Imfinzi recommended for approval in European Union for the treat of adults with limited-stage small cell lung cancer ...

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

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, ...

It is five years since that glorious moment when I stood in the pillared room in Downing Street as a cheering crowd counted ...

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.