FDA+ channel feed – Endpoints News

FDA+ channel feed

Pfizer and Myovant’s endometriosis pain drug Myfembree gets another FDA nod

3 years ago

Democrats secure support from key senator ahead of potential drug pricing vote

3 years ago

Acadia hits another Nuplazid roadblock as the FDA doles out CRL and recommends another trial

3 years ago

FDA issues new guidance for changes to disposable manufacturing materials

3 years ago

Travere fails to convince regulators to consider accelerated approval for a rare kidney disease — again

3 years ago

CDC, NIH, FDA leaders call for US-based clinical trial of smallpox drug in treating monkeypox

3 years ago

Coherus pulls first interchangeable biosimilar win for Lucentis copycat

3 years ago

Drug promotion enforcement so far similar under new FDA chief, with just 4 letters in first half of 2022

3 years ago

J&J nabs label expansion for Stelara in pediatric psoriatic arthritis

3 years ago

Celyad gets the go-ahead to resume CAR-T trial for colorectal cancer as FDA lifts hold

3 years ago

Not yet in the clinic, Beam’s base-edited, off-the-shelf CAR-T put on hold

3 years ago

Arcutis pulls in a win for its topical version of an old AstraZeneca drug in plaque psoriasis

3 years ago

Senate proposes $16B to fund the next wave of Covid-19 vaccines, therapeutics in 2023

3 years ago

Warning letter issued to New Jersey generics manufacturer over quality control issues

3 years ago

Bavarian Nordic's Danish facility gets FDA thumbs up to expand monkeypox vaccine production

3 years ago

St. Louis-based API manufacturer slammed with FDA warning letter over 'pervasive mold,' quality issues

3 years ago

In another accelerated approval quest, Biogen will send its ALS drug to the FDA despite inconclusive data

3 years ago

Drug developer sues FDA over delayed decision on narcolepsy drug

3 years ago

Medexus resubmits NDA as it still looks to repurpose a decades-old drug

3 years ago

On a roll, AstraZeneca flags looming approvals for three big drug franchises

3 years ago

EMA joins regulatory coalition in calling for RWE to be integrated into regulatory decisions

3 years ago

Super-speedy cancer drug reviews: FDA unveils new draft guidance to help sponsors apply

3 years ago

Unlikely duo leads bipartisan Senate bill to expand Right to Try into MDMA and psilocybin

3 years ago

Exclusive: Turnover tsunami at FDA's pharma inspections office puts the backlog in sharp focus

3 years ago

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