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FDA+ channel feed
FDA puts BioNTech’s malaria vaccine on clinical hold
2 months ago
R&D
Misleading exhibit booth panel lands NJ drugmaker an untitled letter from FDA
2 months ago
Marketing
DOGE terminates lease on FDA quality lab in St. Louis and 29 other sites
2 months ago
At least eight drugmakers say they will participate in round two of IRA negotiations
2 months ago
Pharma
CHMP recommends Regeneron, Novartis drugs that still await FDA approval
2 months ago
Pharma
Exclusive: Infectious disease doctors consider 'mini-ACIP' if RFK erodes CDC vaccine panel
2 months ago
CDC is investigating five hospitalizations after use of Valneva’s chikungunya vaccine
2 months ago
Pharma
HHS’ vaccine injury panel in limbo after monthlong meeting delay
2 months ago
FDA meeting to pick next winter's flu shot is canceled, in ominous sign for US vaccine policy
2 months ago
Pharma
After rejection, Regeneron seeks accelerated approval of bispecific for only one of two types of lymphoma
2 months ago
Compounders sue FDA over removal of semaglutide from official shortage list
2 months ago
Law
Some FDA medical device staff reinstated just days after receiving pink slips
2 months ago
Pfizer hires ex-FDA deputy Patrizia Cavazzoni as chief medical officer
3 months ago
People
Pharma
FDA approves first drug to treat ultra-rare lipid storage disease
3 months ago
R&D
CBER's deputy director departs as staff shakeup continues
3 months ago
People
FDA says Ozempic, Wegovy shortage is over
3 months ago
Pharma
Manufacturing
Trump’s HHS defends drug price negotiations in Novartis suit
3 months ago
Pharma
Law
First meeting of CDC vaccine advisors in the Kennedy era is postponed
3 months ago
Bare footprints and blocked inspectors: FDA places two Indian manufacturers on import alerts
3 months ago
Manufacturing
RFK Jr. readies review of childhood vaccine schedule after pledging not to
3 months ago
Bavarian Nordic wins FDA OK for chikungunya vaccine in challenge to Valneva
3 months ago
Pharma
FDA approves Ono’s rare joint tumor drug, setting up battle with Daiichi
3 months ago
Pharma
GSK follows Pfizer in meningococcal vaccine race with new FDA nod
3 months ago
Pharma
Healthcare shakeup hits Washington, with cuts at CDC, NIH and other agencies
3 months ago
Law
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