The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
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Santhera launches DMD therapy in the UK following NICE nodNICE’s positive final guidance for Agamree follows confirmation that no appeals were submitted against its positive December ...
Santhera has begun launch preparations for AGAMREE® in UK with first sales expected in this quarterPratteln, Switzerland, January 16, 2025 – ...
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
Undervalued biotech company Regenxbio Inc. shows promise with cutting-edge gene therapy technology for AMD and MPS II. Click ...
A trial team led by Latham’s Mike Morin and David Frazier and Finnegan’s William (Bill) Raich helped Sarepta Therapeutics ...
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.
Altruism values for treatments of rare, severe pediatric diseases have not been estimated. This study found the altruism value for a hypothetical new Duchenne muscular dystrophy treatment to be $80 ...
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