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FDA+ channel feed
FDA open to use of new MRD endpoint ahead of advisory committee meeting
Last year
Pharma
Endo sues FDA over its handling of generic Adrenalin approvals
Last year
Pharma
Law
Exclusive: Top lobbyist at BIO leaves as trade group grapples with US-China tensions
Last year
People
Novartis, Sanofi and PhRMA push FDA on how to better handle complex trial designs
Last year
Pharma
Virginia governor vetoes bill to create advisory board to reduce drug prices
Last year
Pharma
Indian pharma receives FDA warning letter for barefoot employees and general 'disrepair'
Last year
Pharma
Manufacturing
BrainStorm outlines plans for what may be final attempt to bring ALS drug to market
Last year
R&D
FDA officials raise concerns with immunotherapy overuse for early-stage cancer patients: #AACR24
Last year
Pharma
Nearly half of cancer drugs granted accelerated approval didn’t end up showing clinical benefit — study
Last year
Pharma
Stealth Bio gets FDA adcomm for previously rejected ultra-rare disease drug
Last year
FDA issues second CRL to Supernus for Parkinson's drug-device combo
Last year
FDA approves J&J and Legend’s Carvykti for second-line multiple myeloma
Last year
Pharma
Cell/Gene Tx
FDA grants Enhertu tumor-agnostic accelerated approval
Last year
Pharma
Loosening Medicaid restrictions on hep C drugs could improve patient access, study finds
Last year
Pharma
Bristol Myers and 2seventy win label expansion for Abecma in earlier multiple myeloma
Last year
Pharma
Paxlovid didn’t shorten Covid symptoms in vaccinated adults, full trial results confirm
Last year
Pharma
Coronavirus
FDA approves Basilea’s antibiotic for severe bacterial infections
Last year
Pharma
WuXi builds out lobbying bench amid legislative effort to blacklist company
Last year
China
Pharma
'We beat big pharma': Biden applauds IRA, calls for expansion of Medicare negotiations
Last year
Pharma
Almost all doses of Mounjaro, Zepbound in short supply through Q2
Last year
Pharma
Congress' China hawks seek to add biotech suppliers to Pentagon warning list
Last year
China
CBER's Marks points to stockpiles of H5N1 vaccine as officials monitor reported human case
Last year
Pharma
BMS' confirmatory trial of Krazati hits primary endpoint following 2022 accelerated approval
Last year
Pharma
FDA delays decision on Applied Therapeutics’ rare metabolic disease drug
Last year
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