FDA+ channel feed – Endpoints News

FDA+ channel feed

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

10 months ago

CBER chief floats rare disease hub to better communicate across centers

10 months ago

FDA makes it easier for biosimilars to obtain interchangeability designations

10 months ago

AbbVie adds ulcerative colitis to Skyrizi label

10 months ago

International society criticizes Utah law for permitting unapproved stem cell therapies

10 months ago

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

10 months ago

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

10 months ago

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

10 months ago

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

10 months ago

FDA approves endometrial cancer indications for Keytruda, Imfinzi

10 months ago

Amgen nabs new Blincyto approval for certain type of leukemia

10 months ago

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

10 months ago

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

10 months ago

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

10 months ago

Rare pediatric disease vouchers face uncertain future after September

10 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

Pharma industry praises Supreme Court's rejection of abortion pill challenge

11 months ago

Ultragenyx to seek accelerated approval for rare disease gene therapy

11 months ago

Lilly, Eisai and Biogen seek more specifics in FDA guidance on early Alzheimer’s disease

11 months ago

Updated: FDA funding would stay flat under House appropriations bill

11 months ago

Sanders pushes subpoena vote to force testimony of Novo Nordisk exec on GLP-1 prices

11 months ago

Ipsen and Genfit secure FDA thumbs up for rare liver disease asset

11 months ago

FDA advisors back Lilly’s Alzheimer’s drug, setting stage for approval after delay

11 months ago

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