FDA+ channel feed – Endpoints News

FDA+ channel feed

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

Eye injections causing blindness? FDA’s stem cell clinic crackdown readies for action

4 years ago

FDA adcomm votes in favor of approving Provention Bio’s drug to delay type 1 diabetes

4 years ago

FDA adds new 'do not use' note to Intercept's Ocaliva label after a slew of side effect reports in cirrhosis patients

4 years ago

FDA steers J&J/Legend CAR-T to a quick decision as partners prep a looming showdown with Bristol Myers, bluebird

4 years ago

Five analytics firms launch RWE lobbying group to press Congress, FDA on guidance, Cures 2.0

4 years ago

As FDA clears relugolix for uterine fibroids, Myovant, Pfizer gear up to take on AbbVie in commercial rivalry

4 years ago

Opinion: It shouldn’t matter who the FDA commissioner is when it comes to controversial drug approval decisions

4 years ago

‘Inaccuracies’ push FDA to reverse Trump-era termination of its Unapproved Drugs Initiative

4 years ago

Travere takes a hit as FDA staffers shoo off their accelerated drug pitch

4 years ago

FDA closes the door on EUA requests for some future Covid-19 vaccines

4 years ago

Deaths of monkeys spur clinical hold for rare disease biotech's lead and only drug — and a $95M cash infusion goes out the window

4 years ago

Provention Bio rollercoaster continues with generally positive remarks from FDA ahead of Thursday’s adcomm

4 years ago

FDA may require bispecific antibodies to be compared with monospecific products

4 years ago

US pauses distribution of Lilly mAb combo to Massachusetts due to Covid-19 variant

4 years ago

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