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FDA’s pediatric adcomm votes to continue surveillance of 21 drugs, three vaccines

9 hours ago

Federal judge sides with FDA on its mifepristone safety program

10 hours ago

In first half of 2025, novel drug approvals are in line with previous years

Yesterday

Clinician groups sue RFK Jr. and HHS over Covid-19 vaccine recommendation changes

2 days ago

KalVista CEO says FDA review proceeded normally, was unaware of Makary's rejection ask

2 days ago

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

FDA reviewers advised broad label for Moderna’s next-gen Covid vaccine. Prasad overruled them

Last week

CDC expands RSV vaccine recommendations, siding with previous panel of agency advisors

Last week

After delay, Regeneron wins US approval of bispecific in multiple myeloma

Last week

PBM reforms fail to make the cut as Senate passes Trump’s megabill

Last week

CBER chief Prasad suggests Covid vaccine harms may outweigh benefits in 'low-risk populations'

Last week

FDA loosens safety requirements for CAR-Ts in move to boost access

Last week

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

Rebuilt CDC panel will reassess cumulative vaccine effects, older shots

2 weeks ago

FDA investigating Sarepta’s Duchenne gene therapy following patient deaths

2 weeks ago

Former FDA scientist and psychedelics researcher hired as CDER deputy director

3 weeks ago

RFK Jr. says he did not commit to upholding ACIP roster to secure Cassidy’s backing

3 weeks ago

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

Acting CDER chief is leaving after almost nine years at FDA

3 weeks ago

CHMP recommends five new drugs, reconsiders Eli Lilly’s Kisunla

3 weeks ago

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