FDA+ channel feed – Endpoints News

FDA+ channel feed

mRNA alternative: Novavax finally scores EUA for primary Covid-19 vaccine series

3 years ago

FDA again spells out safety concerns with oral type 1 diabetes drug while denying Lexicon's attempt to overturn a CRL

3 years ago

FDA commissioner's vision: Time to revamp the evidence generation system

3 years ago

Following in FDA's footsteps, EMA plots transition to reviewing raw clinical data

3 years ago

Rx-to-OTC switches: What FDA's new proposed rule means for pharma companies

3 years ago

FDA lifts hold on Greenwich LifeSciences as biotech will forge ahead with immunotherapy drug candidate

3 years ago

Congressional reps push FDA to adopt ‘clear, conspicuous and neutral’ rule for pharma drug ads

3 years ago

HRA Pharma seeks approval for first-ever OTC birth control pill in the US

3 years ago

Florida Gov. DeSantis hints at suing FDA over stalled Canadian drug import plan

3 years ago

Another Indian drug manufacturer hit with a Form 483 over recent observations

3 years ago

Scuttled by a bad IV bag? A small biotech is slapped with a hold following three SAEs

3 years ago

Pulmonologist and frequent NBC guest in consideration for senior role at FDA — report

3 years ago

Two months after CRL, FDA accepts Coherus, Junshi's resubmission for PD-1 studied in China

3 years ago

Alzheimer's quick OK, take two: FDA offers Biogen, Eisai a shortcut to a possible lecanemab approval

3 years ago

OIG report accuses FDA of not following policies for foreign drug inspections

3 years ago

FDA lifts hold on Vertex's diabetes stem cell therapy after just two months under the microscope

3 years ago

Another Duchenne clinical hold gets lifted, this time at Dyne Therapeutics

3 years ago

In a twist, Amylyx's ALS drug will get a second crack at adcomm endorsement after FDA decides to reconvene experts

3 years ago

Covid-19 roundup: Oxford Biomedica and AstraZeneca extend vaccine deal; FDA wants boosters for newer variants

3 years ago

Provention's second shot at FDA approval for diabetes prevention drug hits new hurdle

3 years ago

FDA adds some fresh senior leadership with new chief scientist, chief medical officer

3 years ago

Novartis buys Mallinckrodt's FDA voucher for $100M but remains mum on where to use its 7th PRV

3 years ago

PI3K inhibitor hit with an increased death risk warning from FDA after final trial results emerge

3 years ago

New research argues drug pricing negotiations would stymie innovation, as Democrats fight for revised proposal

3 years ago

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