FDA+ channel feed – Endpoints News

FDA+ channel feed

Senate unveils its version of accelerated approval reforms as bipartisan duo calls on FDA and PTO to work together

4 years ago

Look out, Neulasta: A 5th biosimilar is coming

4 years ago

HHS finishes off Trump-era rule that would've erased basic FDA regs without frequent reviews

4 years ago

Servier expands Tibsovo label with first combination OK in a rare form of AML

4 years ago

FDA spells out the rules and restrictions for states seeking to import drugs from Canada

4 years ago

Antios' HBV collab axed after clinical hold, but biotech believes safety incident is not treatment-related

4 years ago

'Hands may be tied': FDA slaps Verrica with 3rd CRL due to problems with contract manufacturer

4 years ago

Pharma company continues its FDA lawsuit spree, this time after agency denies fast-track designation

4 years ago

With topical approval, Dermavant looks to bring new standard-of-care to plaque psoriasis patients

4 years ago

Manufacturing concerns spur clinical hold on small biotech's Alzheimer's trial — shares plunge

4 years ago

House Republicans attack China-only data in FDA submissions, seek new investigation into research inspections

4 years ago

Updated: FDA calls for noninferiority trials for antibacterials, thanks to new drugs for resistant infections

4 years ago

Bristol Myers dusts off an old Celgene chemotherapy for use in children with a rare blood cancer

4 years ago

'I really don’t look back': Janet Woodcock on her transition away from drugs

4 years ago

Sanofi and Regeneron clear the finish line in an inflammatory esophagus disease, leaving Takeda in the dust

4 years ago

Trying to shake up the Parkinson's paradigm, AbbVie submits NDA for continuous, 24-hour infusion therapy

4 years ago

Sanofi's $20B buyout of Genzyme pays off again with European OK for first Niemann-Pick drug

4 years ago

Flagship's Foghorn, partnered with Merck and Eli Lilly, gets a partial FDA hold after patient death

4 years ago

Proactively preventing shortages: New FDA guidance spells out which drugs require risk management plans

4 years ago

FDA commissioner announces new role for Janet Woodcock, downshifting away from drugs

4 years ago

House committee unanimously advances FDA user fee legislation with accelerated approval tweaks

4 years ago

Senate user fee reauthorization bill omits accelerated approval reforms, shows wide gaps with House version

4 years ago

FDA lobbies Congress over rare disease court ruling with wide implications

4 years ago

Even FDA's Peter Marks is worried about the commercial viability of gene and cell therapies

4 years ago

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