FDA+ channel feed – Endpoints News

FDA+ channel feed

Pfizer rolls out next-gen pneumococcal vaccine with FDA win, beating Merck's 15-valent candidate to the punch

4 years ago

Adcomm member who warned about risk of approving Biogen's aducanumab has resigned following historic OK — reports

4 years ago

Covid-19 vaccines for kids: FDA spells out questions on immunobridging, safety followup ahead of adcomm

4 years ago

FDA rejects Google's push to add virtual exam for Parkinson’s disease to its smartwatch

4 years ago

White House lays out sprawling new plan to shore up pharma and API manufacturing

4 years ago

Opinion: How the FDA bent its rules for Biogen’s Alzheimer’s drug and why that’s bad for the entire biopharma industry

4 years ago

FDA OKs aducanumab for Alzheimer's, turning controversial Biogen drug into a megablockbuster

4 years ago

Novo Nordisk scores a win for semaglutide in obesity, potentially setting up a next-gen battle with Eli Lilly

4 years ago

Regeneron continues reign atop the Covid treatment field with expanded EUA for lower dose subcutaneous version of mAb cocktail

5 years ago

Biopharma supply chain security: FDA guidance spells out new expectations

5 years ago

Amryt earns a priority review in a rare disease that makes patients' skin fragile as butterfly wings

5 years ago

Former FDA No. 2 Amy Abernethy rejoins Robert Califf at Google's Verily, hopping aboard as clinical R&D head

5 years ago

Scynexis will pit a new class of antifungals against yeast infections — and it won't come cheap

5 years ago

Appeals court sides with FDA in lawsuit over fat-derived stem cell procedure

5 years ago

GlaxoSmithKline scores a win in Zofran case after FDA repeatedly said pregnancy risk data did not require label changes

5 years ago

A major reshuffling at the FDA opened the road for Biogen’s Alzheimer’s drug. Can it cross the finish line?

5 years ago

After taking a look at new data, regulators put J&J's BCMA/CD3 bispecific on a 'breakthrough' track

5 years ago

Alkermes wins FDA nod for combo med with antipsychotic olanzapine — this time without the weight gain red flags

5 years ago

Biden HHS seeks to dismiss PhRMA’s lawsuit to stop Canadian drug imports

5 years ago

Biden 2022 budget wish list calls for Medicare negotiations on drug prices, new $6.5B NIH agency

5 years ago

Amgen cracks the undruggable code, earning the FDA's nod for first-ever KRAS inhibitor

5 years ago

FDA hands a CRL to drugmaker Eton after a delayed inspection — but are Covid-19 travel restrictions really the issue?

5 years ago

Biohaven earns preventative nod for migraine med Nurtec, snaring a much-needed leg up over AbbVie

5 years ago

Bristol Myers gets its first GI drug approval, and it comes from a longtime Celgene MS program

5 years ago

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