FDA+ channel feed – Endpoints News

FDA+ channel feed

House committee presses FDA on signs of inconsistent inspections in China and India

11 months ago

Argenx wins second FDA approval for Vyvgart in autoimmune nerve disease

11 months ago

Peter Marks single-handedly approved Sarepta’s gene therapy — what does that mean for everyone else?

11 months ago

Bristol Myers wins approval for KRAS drug Krazati in colorectal cancer

11 months ago

FDA ships two Form 483s to Dr. Reddy’s for two separate sites in India

11 months ago

Lexicon resubmits type 1 diabetes drug to FDA five years after rejection

11 months ago

FDA widens Sarepta’s Duchenne gene therapy label to older boys in significant expansion of use

11 months ago

FDA to pharma companies: Using CRO Synapse's studies 'unacceptable'

11 months ago

CBER chief floats rare disease hub to better communicate across centers

11 months ago

FDA makes it easier for biosimilars to obtain interchangeability designations

11 months ago

AbbVie adds ulcerative colitis to Skyrizi label

11 months ago

International society criticizes Utah law for permitting unapproved stem cell therapies

11 months ago

FDA loosens side effect reporting requirements for some CAR-T therapies

11 months ago

FTC backs plan to target more patent settlements it sees as anticompetitive

11 months ago

After two patient deaths from presumed sepsis, FDA puts partial hold on Zentalis studies

11 months ago

Merck's 21-valent pneumococcal vaccine for adults wins FDA approval

11 months ago

FDA approves endometrial cancer indications for Keytruda, Imfinzi

11 months ago

Amgen nabs new Blincyto approval for certain type of leukemia

11 months ago

Updated: FDA places partial hold on BioNTech-MediLink ADC after multiple deaths

11 months ago

FDA asks Covid-19 vaccine makers to instead target KP.2 strain for fall season

11 months ago

Ending 'product hopping' and other patent changes could save US $3B over a decade, CBO says

11 months ago

Rare pediatric disease vouchers face uncertain future after September

11 months ago

Bristol Myers' cancer drug Augtyro wins new accelerated approval in solid tumors

11 months ago

Stakeholders weigh in on potential reforms to FDA advisory committee process

11 months ago

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