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MHRA seeks input on new regulatory guidance for cancer vaccines
The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.
ophthalmologytimes4d
CHMP of the European Medicines Agency issues positive opinion on 2 aflibercept biosimilars
The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...
EurekAlert!10d
High-quality evidence for the treatment of very rare diseases: IQWiG is involved in the EU project RealiseD
High-quality evidence for the treatment of very rare diseases: IQWiG is involved in the EU project RealiseD Developing clinical trials to provide good evidence for very rare diseases, so that ...
EU medicines agency quits X, moves to Bluesky
The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...
centerforbiosimilars4d
BioRationality: No More Biosimilars—Just Biogenerics
Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...
Business Wire1mon
CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis in the European Union
ZUG, Switzerland--(BUSINESS WIRE)--Galderma today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and ...