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FDA+ channel feed
FDA's ad enforcer critiques Brittany Mahomes' paid Instagram post for Kaléo
10 months ago
Pharma
vTv Therapeutics' diabetes drug program hit with clinical hold from FDA
10 months ago
R&D
Compounded weight loss drugs have resulted in misdosing, hospitalizations, FDA warns
10 months ago
Pharma
Health Tech
Among pharma CEOs, the IRA now and the IRA later get very different reactions
10 months ago
Pharma
Law
FDA approves Sun Pharma's JAK inhibitor Leqselvi for hair loss in adults
10 months ago
Pharma
FDA advisors call for better studies of immunotherapy around lung cancer surgery, but give AstraZeneca a pass
10 months ago
R&D
Pharma
EU panel follows FDA’s lead on Wegovy, recommending use to prevent cardiac events
10 months ago
Pharma
BioMarin snags expanded Brineura label, now approved for all kids regardless of symptoms
10 months ago
Pharma
FDA finalizes guidance on using EHR data to support drug submissions
10 months ago
Rare pediatric PRV reauthorization faces uncertain fate as summer recess approaches
10 months ago
Law
FDA asks adcomm if AstraZeneca needs another study on Imfinzi before and after lung cancer surgery
10 months ago
Pharma
Indian manufacturer Brassica hit with warning letter after employees faked data results
10 months ago
Manufacturing
Bluebird bio handed negative opinion from federal oversight agency for fertility support program
10 months ago
Pharma
Law
Updated: Samsung wins FDA approval for second Soliris biosimilar
10 months ago
Pharma
EMA reasserts differences with FDA for Covid vaccine strain selection
10 months ago
Coronavirus
Phathom wins label expansion on heartburn drug to include non-erosive patients
10 months ago
J&J has its final offer in hand from the government over IRA pricing
10 months ago
Pharma
FDA announces rare disease hub in bid to streamline treatment paths
10 months ago
Big three PBMs will testify before Congress next week, following FTC report
10 months ago
Pharma
FDA again rejects Orexo's nasal spray for opioid overdose rescue
10 months ago
FDA warns Chinese drugmaker for serious GMP record violations
10 months ago
Manufacturing
EMA warns patients to tell doctors about GLP-1 usage before surgery
10 months ago
Pharma
How SCOTUS' decision in Chevron could change the way the FDA regulates biopharma
10 months ago
Law
Senate unanimously passes bipartisan pharma patent bill
10 months ago
Pharma
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