FDA+ channel feed – Endpoints News

FDA+ channel feed

VBI Vaccines execs tout approval of new triple-antigen hepatitis B shot. Can they sell it?

4 years ago

Months after shocking investors with lung cancer win, BeyondSpring's lead drug hits roadblock at the FDA

4 years ago

FDA adcomm narrowly votes in favor of Merck's antiviral for outpatient Covid-19

4 years ago

FDA cancels ODAC meeting this week as Secura Bio pulls accelerated approval

4 years ago

ImmunoGen touts a PhIII comeback in ovarian cancer, eyeing a 2022 accelerated approval

4 years ago

FDA raises concerns over TG Therapeutics' survival data, plans to convene ODAC

4 years ago

How to use registry data to support FDA decision making: Agency explains in new guidance

4 years ago

More manufacturing issues: Fennec preps for second CRL for potential hearing loss drug

4 years ago

Like the flu vaccine every year, the FDA could move quickly on a variant-targeted Covid vaccine

4 years ago

Amid JAK debacle, Bristol Myers settles in for FDA's long review of potential first TYK2 drug

4 years ago

Ocugen hits another snag in bringing its Bharat Biotech-partnered Covid-19 vaccine to the US

4 years ago

Merck shares slide as response to its oral Covid antiviral plunges on latest update ahead of adcomm

4 years ago

FDA commish nominee's financial disclosures reveal a vast web of industry ties. Will they matter?

4 years ago

FDA asks court for 55 years to complete a FOIA request on the Pfizer/BioNTech vaccine

4 years ago

FDA hits the red light on an early-stage AML study after a patient dies

4 years ago

After a rocky decades-long journey, Takeda’s CMV drug gets FDA OK

4 years ago

FDA approves pricey new treatment for ultra-rare and aggressive form of sarcoma

4 years ago

House committee wants former FDA commissioner to come clean on Covid-related political interference

4 years ago

New Pfizer/BioNTech Covid vaccine data in teens show strong protection, lining up sBLA filing

4 years ago

FDA opens up an ethical can of worms with accelerated approval for first drug for underlying genetic cause of dwarfism

4 years ago

FDA delays its decision on Bristol Myers' $13B heart drug another three months

4 years ago

Exclusive: FDA probing death of Aduhelm patient as Biogen's Alzheimer's drug continues to stir controversy

4 years ago

Merck's Keytruda scores first win in adjuvant kidney cancer, giving it a leg up on checkpoint inhibitor rivals

4 years ago

FDA+ roundup: ALS bill would provide $100M annually to access potential drugs; FDA needs to better enforce ClinicalTrials.gov reporting, researchers say

4 years ago

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