FDA+ channel feed – Endpoints News

FDA+ channel feed

Pfizer has run 41 trials over 15 years for tanezumab. As adcomm nears, the FDA remains unimpressed — and more than a little worried

5 years ago

PhRMA attacks New Mexico’s ‘short on detail’ plan for Canadian drug imports

5 years ago

A packed MS market is about to get busier as J&J's ponesimod enters the fray

5 years ago

Kiniksa touts 3rd approval for aging Arcalyst — a good haul for just $5M in cash it paid Regeneron for the drug

5 years ago

UK drug regulator to restart inspections at the end of March with a focus on social distancing

5 years ago

FDA spells out how the Covid-19 variants impact the effectiveness of Regeneron, Eli Lilly mAb treatments

5 years ago

HHS postpones review of over 95% of FDA’s regulations so critical resources are not diverted from Covid-19

5 years ago

Recall report: Sagent Pharma pulls low blood pressure med for loose sealing on sterile vials

5 years ago

EMA calls for AstraZeneca vaccinations to continue after safety scares delayed rollout

5 years ago

Eli Lilly’s Covid-19 drug bamlanivimab is no longer distributed in 3 states because of a variant, Woodcock says

5 years ago

Europe mulls halting Covid-19 vaccine exports to some countries

5 years ago

Court win for Eli Lilly halts HHS’s drug discount rule

5 years ago

FTC pledges to aggressively crack down on pharma mergers

5 years ago

Merck wins priority review for rare carcinoma drug belzutifan, the centerpiece of $1B+ Peloton buyout

5 years ago

FDA requires Regeneron, Lilly to monitor variants as a condition of mAb EUAs

5 years ago

What’s in a (drug) name? FDA to study how they affect efficacy perceptions

5 years ago

Melinta Therapeutics nabs FDA nod for more convenient rework of antibiotic Orbactiv, a former Eli Lilly candidate

5 years ago

EMA begins safety review of bluebird gene therapy following AML case in related therapy

5 years ago

Trump’s HHS planted ‘ticking timebomb’ to sunset thousands of regs, lawsuit says

5 years ago

Three-day FDA adcomm to feature unprecedented review of Merck, Roche and BMS accelerated approvals

5 years ago

Recall report: BRP Pharma pulls 47 bottles of generic diuretic spironolactone after mixing different strength pills

5 years ago

FDA delays Kadmon’s priority review as apparent clampdown continues

5 years ago

Aveo Oncology gets the long-awaited greenlight to market tivozanib — 9 years after filing its first NDA

5 years ago

FDA calls out Kardashian drug promo video for false claims

5 years ago

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