FDA+ channel feed – Endpoints News

FDA+ channel feed

CHMP recommends 14 new approvals, seven label expansions

12 months ago

FDA approves Moderna's RSV vaccine, marking its second commercial product

12 months ago

FDA delays Dupixent in COPD decision by three months while EMA gives thumbs-up

12 months ago

Gilead’s blockbuster ADC Trodelvy fails bladder cancer confirmatory study

12 months ago

Lab group sues FDA over final rule regulating laboratory-developed tests

12 months ago

Bristol Myers' CAR-T therapy Breyanzi adds new approval in mantle cell lymphoma

12 months ago

FDA to begin restructuring its inspection office in October

12 months ago

Doctors who endorse drugs on social media are often compensated, JAMA study finds

12 months ago

FDA approves Tris Pharma's non-stimulant pediatric ADHD liquid medication

12 months ago

Lilly's Retevmo lands new accelerated approval for pediatric cancers

12 months ago

Amgen nabs FDA approval for first Soliris interchangeable biosimilar

12 months ago

NIH-funded trials often miss diversity targets, small study shows

Last year

FDA details new 'platform technology' process that could accelerate cell and gene therapy approvals

Last year

NIH officials used personal emails, tweaked words to skirt FOIA searches during pandemic, lawmakers find

Last year

Second engineered B cell therapy enters the clinic, promising to do in hemophilia B what gene therapies can't

Last year

FDA advisory committee says risks of Novo Nordisk’s once-weekly insulin outweigh benefits in type 1 diabetes patients

Last year

Public Citizen sues FDA over citizen petition on SSRI sexual side effects labeling

Last year

FDA denies Ipsen's citizen petition for blockbuster drug Somatuline

Last year

FDA questions hypoglycemia risk for Novo Nordisk's once-weekly insulin ahead of adcomm

Last year

House committee presses FDA center directors on domestic manufacturing, LDTs

Last year

FDA's Marks, Woodcock talk regulatory flexibility for new rare disease drugs

Last year

NIH drafts policy on ensuring access to new drugs funded by taxpayers

Last year

Senators strike bipartisan tone on more pharma patent reforms

Last year

Sen. Wyden questions Pfizer over tax rate as part of ongoing investigation

Last year

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