FDA+ channel feed – Endpoints News

FDA+ channel feed

BioMarin gets its dwarfism drug in the FDA's door — but can they change regulators’ minds about a longer follow up?

5 years ago

FDA scuttles bluebird's accelerated plans for sickle cell gene therapy, as higher CMC bar forces 1-year delay

5 years ago

FDA insider review offers a stellar endorsement for Biogen’s controversial aducanumab to treat Alzheimer’s — but statistical analysis mars the picture

5 years ago

An election night bereft of answers quells biopharma's 'worst-case' fears — analysts

5 years ago

The Endpoints poll: A large majority of biopharma execs turn thumbs down on Biogen's controversial pitch for aducanumab

5 years ago

With sales rising and efficacy questions swirling, Gilead faces calls to relinquish lucrative priority review voucher

5 years ago

Promising mRNA tech comes with regulatory, CMC headaches

5 years ago

PS: Did anyone at Biogen ask the FDA to pull an aducanumab conscientious objector off their expert panel? ‘No comment’

5 years ago

The Endpoints News poll: Should the FDA panel back an approval for aducanumab, or should they send Biogen packing?

5 years ago

Orchard halts dosing of EMA-approved Strimvelis after patient develops leukemia

5 years ago

Biogen dodges a bullet in its controversial quest to gain an approval for their experimental Alzheimer’s drug aducanumab

5 years ago

PDUFA VII: FDA and industry set priorities in first round of negotiations

5 years ago

Novo Nordisk quietly nabs a rare 'breakthrough' status in NASH for its cash cow

5 years ago

Enhertu picks up another win for AstraZeneca and Daiichi Sankyo, joining the priority review lane for gastric cancer

5 years ago

Once rejected, Kala's dry eye drug now gains entry to a field where Novartis is grooming its own blockbuster

5 years ago

Ultragenyx slams the brakes on rare disease study after all 5 patients are hit with a serious setback

5 years ago

Pandemic travel restrictions force FDA to delay a BLA review — involving a site inspection in Korea

5 years ago

FDA gives AstraZeneca the thumbs-up to restart PhIII Covid-19 vaccine trials, and J&J is preparing to resume its study

5 years ago

In historic Covid-19 adcomm, vaccine experts debate a sea of questions — but offer no clear answers

5 years ago

FDA anoints Gilead's remdesivir as the Covid-19 treatment winner, handing down full approval — despite some deep skepticism

5 years ago

On morning of FDA Covid-19 adcomm, Moderna completes PhIII enrollment, putting them neck-and-neck with Pfizer

5 years ago

Little Zosano takes another beating as the FDA slaps down their application for a migraine patch

5 years ago

As FDA sets the stage for the first Covid-19 vaccine EUAs, some big players are asking for a tweak of the guidelines

5 years ago

Oncology research mid-pandemic: Challenges may bring durable innovation

5 years ago

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