FDA+ channel feed – Endpoints News

FDA+ channel feed

Turmoil at CBER: Peter Marks grabs control of FDA's Office of Vaccines ahead of 2 key career leader departures

4 years ago

Seizing Aduhelm precedent, Biogen, Eisai get the ball rolling on another accelerated Alzheimer's approval

4 years ago

After pumping the brakes on their Angelman syndrome study, Ultragenyx and GeneTx are back in the race

4 years ago

New ARIA cases dog Biogen's Aduhelm launch in another potential blow to blockbuster hopes — analyst

4 years ago

CDC director overrules advisors on boosters, recommending third shots for at-risk workers

4 years ago

FDA's cancer drug advisors will review 2 more dangling accelerated approvals for multiple myeloma, leukemia

4 years ago

Following controversial Aduhelm approval, DC-based neurology center bans Biogen representatives from its offices — report

4 years ago

Mitch McConnell, top Republicans question Biden on getting ahead of FDA on Covid-19 boosters

4 years ago

Incyte's ruxolitinib scores its second approval in two days, this time in chronic graft-versus-host disease

4 years ago

The FDA objects to biotech billionaire Bob Duggan’s PhIII plans — and he’s not budging

4 years ago

FDA+ roundup: BsUFA III ready for showtime, court tells FDA to re-work compounding plan, new guidance updates and more

4 years ago

Incyte nabs approval of topical ruxolitinib in atopic dermatitis, but gets slapped with JAK warning

4 years ago

When efficacy is borderline: FDA needs to get more consistent on close-call drug approvals, agency-funded research finds

4 years ago

Verrica hits another bump in the road with CMO related letter from FDA

4 years ago

FDA hands accelerated nod to Seagen, Genmab's solo ADC in cervical cancer, but combo studies look even more promising

4 years ago

Exelixis pulls a surprise win in thyroid cancer just days ahead of final Cabometyx readout

4 years ago

Skin tumors in mice force Protagonist to halt lead program, crushing stock

4 years ago

The biggest questions facing gene therapy, the XLMTM community, and Astellas after fourth patient death

4 years ago

Takeda scores a win for a rare type of lung cancer, gearing up for a showdown with J&J

4 years ago

Not so fast: FDA tacks 3 more months onto decision date for Calliditas' rare kidney disorder drug

4 years ago

Once held back, Amylyx execs say the FDA is now pushing for an NDA on ALS drug

4 years ago

Five months after getting slapped with a clinical hold, KalVista gets the OK to restart oral HAE program

4 years ago

Data do not support widespread Covid vaccine boosters right now, outgoing FDA leaders write in the Lancet

4 years ago

FDA head Janet Woodcock raises patent-related concerns to PTO director

4 years ago

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