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FDA+ channel feed
FDA’s pediatric adcomm votes to continue surveillance of 21 drugs, three vaccines
12 hours ago
Federal judge sides with FDA on its mifepristone safety program
12 hours ago
Law
In first half of 2025, novel drug approvals are in line with previous years
Yesterday
Pharma
Clinician groups sue RFK Jr. and HHS over Covid-19 vaccine recommendation changes
2 days ago
R&D
Pharma
KalVista CEO says FDA review proceeded normally, was unaware of Makary's rejection ask
2 days ago
People
Pharma
FDA chief calls for 'meaningful' reduction of animal testing for new drugs
2 days ago
Dizal’s lung cancer pill approval sets up competition with J&J
6 days ago
Pharma
FDA reviewers advised broad label for Moderna’s next-gen Covid vaccine. Prasad overruled them
Last week
Pharma
CDC expands RSV vaccine recommendations, siding with previous panel of agency advisors
Last week
Pharma
After delay, Regeneron wins US approval of bispecific in multiple myeloma
Last week
Pharma
PBM reforms fail to make the cut as Senate passes Trump’s megabill
Last week
R&D
Pharma
CBER chief Prasad suggests Covid vaccine harms may outweigh benefits in 'low-risk populations'
Last week
R&D
Pharma
FDA loosens safety requirements for CAR-Ts in move to boost access
Last week
R&D
FDA head Makary’s short-lived CRL ask on KalVista’s drug raises more concerns of political intervention
Last week
Debate on a long-scrutinized vaccine ingredient consumes CDC panel in its second day
Last week
R&D
Rebuilt CDC panel will reassess cumulative vaccine effects, older shots
2 weeks ago
R&D
FDA investigating Sarepta’s Duchenne gene therapy following patient deaths
2 weeks ago
Cell/Gene Tx
Former FDA scientist and psychedelics researcher hired as CDER deputy director
3 weeks ago
People
RFK Jr. says he did not commit to upholding ACIP roster to secure Cassidy’s backing
3 weeks ago
Pharma
Exclusive: FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say
3 weeks ago
The politics of vaccination take center stage as RFK Jr.’s rebuilt CDC panel is set to meet
3 weeks ago
AstraZeneca, Daiichi Sankyo gain lung cancer indication for Enhertu successor
3 weeks ago
Pharma
Acting CDER chief is leaving after almost nine years at FDA
3 weeks ago
People
CHMP recommends five new drugs, reconsiders Eli Lilly’s Kisunla
3 weeks ago
Pharma
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