FDA+ channel feed – Endpoints News

FDA+ channel feed

As FDA lifts clinical hold on its $4.9B CD47 drug, Gilead talks 2023 readout, 'unwavering' confidence

4 years ago

FDA quietly chats with states on drug import plans — signaling Biden isn't ready to dispense with Trump's idea

4 years ago

Vanda takes FDA to court again, this time seeking more info on a rejection letter

4 years ago

Patient death triggers a second clinical hold for Curis as FDA seeks more data

4 years ago

How CMS independence is at the forefront of its Alzheimer's drug coverage decision

4 years ago

Final coverage decision for some Alzheimer's drugs is almost here: What to remember and what to expect

4 years ago

In a one-two gut punch after kidney drug CRL, Akebia slapped with partial hold and will lay off 42% of staff

4 years ago

Quality metrics for pharma manufacturing is back in a big way, with FDA pledging to 'objectively rate' firms

4 years ago

Psych and neuro R&D notch a win as BioXcel gets FDA approval for schizophrenia, bipolar disorder-related agitation

4 years ago

FDA's court-mandated release of Pfizer Covid-19 vaccine documents continues to turn over few surprises

4 years ago

FDA halts the use of GSK's Covid-19 drug completely as BA.2 subvariant blankets the country

4 years ago

Novartis' PI3K drug, already approved in breast cancer, nabs a speedy OK to treat ultra-rare condition

4 years ago

Senators grill industry groups over FDA user fee agreements to fund the agency through 2027

4 years ago

Senators call on HHS to investigate McKinsey's alleged ties with FDA, opioid manufacturers

4 years ago

FDA convenes committee of vaccine experts to consider a flu-like path for Omicron-specific boosters

4 years ago

CDER chief calls for additional budget funds as staff departures spiked last summer

4 years ago

FDA tees up a snap review for Dupixent as Sanofi, Regeneron hunt 4th approval for megablockbuster

4 years ago

Ned Sharpless steps down as head of the National Cancer Institute

4 years ago

More biosimilar use could've saved Medicare and beneficiaries $84M in 2019, HHS OIG says

4 years ago

Merck's pneumococcal vaccine suffers PDUFA delay in pediatric population, with Pfizer hot on its tail

4 years ago

FDA chief Rob Califf: The business of health is booming but people's outcomes aren't improving

4 years ago

Cancer drug developers will learn from the blazing speed of the Covid-19 vaccine race, FDA leaders say

4 years ago

After an RTF and some stern warnings, FDA slaps CytoDyn with two clinical holds

4 years ago

FDA advisors vote 6-4 against Amylyx's ALS drug, further dimming its hope for regulatory success

4 years ago

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