FDA+ channel feed – Endpoints News

FDA+ channel feed

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

5 years ago

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

5 years ago

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

5 years ago

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

5 years ago

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

5 years ago

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

5 years ago

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

5 years ago

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

5 years ago

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

5 years ago

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

5 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

5 years ago

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

5 years ago

FDA may require bispecific antibodies to be compared with monospecific products

5 years ago

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

5 years ago

J&J beats Tagrisso and Takeda to the punch in key NSCLC subset, picking up new FDA approval

5 years ago

Bristol Myers' Opdivo leads the pack with FDA approval for resected esophageal or GEJ cancer

5 years ago

Bluebird’s new gene therapy among three new EMA OKs ahead of FDA

5 years ago

Takeda tees up priority review for storied CMV drug from its $62B Shire buyout

5 years ago

Eli Lilly sues HHS to halt any 340B-related monetary penalties

5 years ago

FDA revises and expands draft guidance on adjusting for covariates in RCTs

5 years ago

FDA adcomm to review FibroGen’s chronic kidney disease drug in July

5 years ago

FDA+ roundup: Flurry of guidance documents, updated risk criteria for Covid-19 mAbs, personnel moves and more

5 years ago

Opinion: Congress needs to take a hard look at what went on at Trump's White House during the pandemic

5 years ago

CMC holdup delays Iovance filing again — to 2022 — as FDA seeks more assay data for TIL therapy

5 years ago

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