FDA+ channel feed – Endpoints News

FDA+ channel feed

Must-pass user fee deals: Biopharma companies fund more than 80% of FDA's review staff, CDER head tells Congress

4 years ago

Takeda abandons one of its top experimental drugs following a slap down at the FDA

4 years ago

Exclusive: The curious case of the BioNTech priority review voucher

4 years ago

That partial hold on Gilead's $5B cancer drug? It's worse than we were initially told

4 years ago

FDA slams clinical hold on LogicBio's gene editing drug after clotting cases in child patients

4 years ago

FDA takes a rare step and asks Pfizer to submit a Covid-19 vaccine EUA for the youngest children

4 years ago

Biogen leaps into a showdown between Roche and Regeneron, betting on a potential new franchise player

4 years ago

After sputtering on the launch pad, Novavax finally gets its EUA application in. Does it matter?

4 years ago

In pledging to vote for Rob Califf, Elizabeth Warren takes a swing at the FDA-industry revolving door

4 years ago

The FDA approves Moderna's revolutionary new Covid-19 vaccine. What took so long?

4 years ago

Which FDA guidance documents are coming for drugmakers in 2022? Agency unveils new lists

4 years ago

FDA clears Roche’s bispecific Eylea contender, but can it compete with the Regeneron blockbuster?

4 years ago

Regeneron and Sanofi pull Libtayo app in cervical cancer, citing post-market study disagreement with FDA

4 years ago

Rob Califf's nomination to be the next FDA commissioner is now in serious limbo

4 years ago

Updated: JAK woes continue as Eli Lilly warns of possible Olumiant CRL for atopic dermatitis and reports PhIII fail in lupus

4 years ago

Amgen, Regeneron and others seek more detail from FDA on real-world data plans

4 years ago

FDA offers new guidance to help generic drug developers get to market more quickly

4 years ago

Biotech gets burned at a fireside chat as CEO reveals FDA clamped a hold on its cancer drug, now under review

4 years ago

Under pressure, Biogen outlines ambitious diversity goals for Aduhelm study — but the Medicare fight is still on

4 years ago

Pfizer wants to help the FDA with its new, court-mandated $4-5M FOIA release on the company's Covid-19 vaccine data

4 years ago

Roche nabs a priority review for Evrysdi, hoping to become the first oral treatment for infants with SMA

4 years ago

FDA+ roundup: Janet Woodcock defends her 'most' will get Covid comment, talks shortages and government trust

4 years ago

Cortexyme switches direction, announces layoffs after FDA slaps hold on dark horse Alzheimer’s candidate

4 years ago

FDA hurries up a quick approval for the world's first TCR — after a 14-year R&D trek

4 years ago

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