FDA+ channel feed – Endpoints News

FDA+ channel feed

EU panel follows FDA’s lead on Wegovy, recommending use to prevent cardiac events

9 months ago

BioMarin snags expanded Brineura label, now approved for all kids regardless of symptoms

9 months ago

FDA finalizes guidance on using EHR data to support drug submissions

9 months ago

Rare pediatric PRV reauthorization faces uncertain fate as summer recess approaches

9 months ago

FDA asks adcomm if AstraZeneca needs another study on Imfinzi before and after lung cancer surgery

9 months ago

Indian manufacturer Brassica hit with warning letter after employees faked data results

9 months ago

Bluebird bio handed negative opinion from federal oversight agency for fertility support program

9 months ago

Updated: Samsung wins FDA approval for second Soliris biosimilar

9 months ago

EMA reasserts differences with FDA for Covid vaccine strain selection

9 months ago

Phathom wins label expansion on heartburn drug to include non-erosive patients

9 months ago

J&J has its final offer in hand from the government over IRA pricing

9 months ago

FDA announces rare disease hub in bid to streamline treatment paths

9 months ago

Big three PBMs will testify before Congress next week, following FTC report

9 months ago

FDA again rejects Orexo's nasal spray for opioid overdose rescue

9 months ago

FDA warns Chinese drugmaker for serious GMP record violations

9 months ago

EMA warns patients to tell doctors about GLP-1 usage before surgery

9 months ago

How SCOTUS' decision in Chevron could change the way the FDA regulates biopharma

10 months ago

Senate unanimously passes bipartisan pharma patent bill

10 months ago

FDA rejects Novo Nordisk’s once-weekly insulin after questioning risks

10 months ago

CMS rolls out policy proposals on non-opioid drugs, radiopharmaceuticals — Lantheus stock jumps

10 months ago

House committee raises concerns on CDER-CBER misalignment amid 2025 funding markup

10 months ago

Arcutis tacks on atopic dermatitis approval for Zoryve cream

10 months ago

Zevra to face FDA adcomm in August over previously rejected rare disease drug

10 months ago

FTC says PBMs ‘exercise vast control’ over healthcare, but stops short of calling for antitrust action

10 months ago

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