FDA+ channel feed – Endpoints News

FDA+ channel feed

Pfizer says RSV shot to protect infants may be available by 2023-24 cold and flu season

3 years ago

CMS to work closely with FDA on accelerated approval payment reforms

3 years ago

FDA to take another look at Akebia's rejected kidney drug

3 years ago

Alnylam gets an adcomm for Onpattro treatment in ATTR amyloidosis

3 years ago

Astellas' menopause drug hit by FDA delay after spending $97M on a priority review voucher

3 years ago

FDA clears Travere’s rare kidney disease drug, will come with REMS program

3 years ago

FDA approves Apellis' retinal disease drug as competitor expects August decision

3 years ago

FDA's No. 2 oncology official departs for biotech startup

3 years ago

FDA accepts Iveric Bio's NDA, grants priority review for GA drug

3 years ago

Merck seeks more approvals for infectious disease drug

3 years ago

FDA gives the OK to Chiesi for treatment of ultra-rare enzyme deficiency disease

3 years ago

UK could allow reciprocal drug approvals with US FDA as soon as 2024

3 years ago

Over-the-counter Narcan gets unanimous thumbs-up from FDA advisors

3 years ago

Moderna promises to provide vaccines at no out-of-pocket cost

3 years ago

Thousands of gene and cell therapies are inundating FDA reviewers as the agency tries to keep up

3 years ago

FDA to review Galera’s drug for radiotherapy complication, biotech immediately seeks $30M

3 years ago

In a first, CMS will test paying less for drugs cleared via accelerated approval

3 years ago

FDA revises action on compounded ibuprofen, citing oral version shortage

3 years ago

Law experts argue that abortion drug withdrawal would 'undermine' the approval process

3 years ago

Updated: FDA adds warning of 'larger areas of bleeding' in brain to Biogen's Aduhelm label

3 years ago

FDA hands down RTF letter to rare disease biotech's lead candidate

3 years ago

Should Narcan spray be sold over the counter? FDA poses potential packaging changes

3 years ago

Sun Pharma issues recall for more than 34,000 bottles of blood pressure medication

3 years ago

FDA rejects Biocon and Viatris' Avastin biosimilar after inspection question marks

3 years ago

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