The European Parliament has formally adopted new pharmaceutical legislation, including proposals for a new directive and a new regulation. 11 April 2024
The US Food and Drug Administration has given a green light to BrainStorm Cell Therapeutics (Nasdaq: BCLI) for the design of a Phase IIIb trial for NurOwn (MSC- 10 April 2024
Research suggests there will likely be strong uptake for the first USA-approved therapy for metabolic dysfunction-associated steatohepatitis (MASH). 9 April 2024
The US regulator has for once again rebuffed efforts on the part of Supernus Pharmaceuticals (Nasdaq: SUPN) to register its Parkinson’s disease candidate SPN-83 9 April 2024
Following its initial investigation into the acquisition by Theramex of certain drug rights held by Viatris, the UK’s antitrust body has said the transaction: “ 5 April 2024
A second Expert View piece from Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at Pharm 4 April 2024
Bimzelx (bimekizumab-bkzx) has taken a step closer to US approval, with the US regulator accepting a supplemental Biologics License Application in hidradenitis 4 April 2024
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