FDA+ channel feed – Endpoints News

FDA+ channel feed

Bristol Myers' subcutaneous version of Opdivo gets earlier PDUFA date

Last year

FDA lifts partial clinical hold on Larimar’s Friedreich’s ataxia treatment

Last year

FDA withdraws Helsinn’s accelerated approval for cancer drug after company’s request

Last year

PTC's muscular dystrophy drug Translarna to get another review in the EU

Last year

FDA approves first two interchangeable biosimilars to Regeneron's blockbuster Eylea

Last year

Updated: Lobbying group BIO restructures staff in shakeup under new CEO

Last year

Study identifies groups of people who mistrust the FDA

Last year

EMA's safety committee recommends suspending preterm birth drugs

Last year

FDA rejects liver cancer drug combo, shares of Korean biotech tank

Last year

Q&A: FTC’s top healthcare enforcer on pharma M&A, company growth and PBMs

Last year

FDA approves Amgen’s T cell engager in aggressive form of lung cancer

Last year

House panel advances bills targeting rare disease, priority review vouchers

Last year

Bristol Myers' CAR-T therapy Breyanzi adds follicular lymphoma to list of approvals

Last year

WHO greenlights Takeda's dengue vaccine as company plans to 're-engage' with FDA

Last year

As adcomm looms, ICER raises questions over Lykos’ MDMA studies

Last year

Eisai heads to FDA with subcutaneous version of Alzheimer’s treatment developed with Biogen

Last year

Ascendis’ hypoparathyroidism drug saddled with three-month delay at FDA

Last year

Destruction of documents, insufficient data lead FDA to reject hep B vaccine update

Last year

FDA offers more clarity on safety testing for cell therapies

Last year

WHO members miss deadline for pandemic accord draft, will continue talks

Last year

New Biosecure draft features 2032 grandfather clause, five-year grace period for added companies

Last year

Senators question Chamber of Commerce's motives around march-in rights

Last year

Corrected: Experts to decide within a year whether to recommend Duchenne muscular dystrophy for newborn screening

Last year

Ahead of likely approval, ICER finds Geron’s imetelstat is not cost-effective at $250,000 annually

Last year

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