FDA+ channel feed – Endpoints News

FDA+ channel feed

One year into clinical hold, FDA has more questions about 'pooled' microbiome therapy

3 years ago

Hoping to expand monkeypox vaccine supply, US paves the way for new route of administration

3 years ago

Civica, Mayo Clinic and others sound off on FDA draft guidance to mitigate drug shortages

3 years ago

To avoid shortage of Merck's diabetes drug, FDA allows higher impurity levels temporarily

3 years ago

Updated: FDA slaps Amazon with a warning letter for selling OTC mole removal products

3 years ago

Reata’s ‘regulatory concerns’ turn into three-month delay on FDA decision for Friedreich’s ataxia drug

3 years ago

CorMedix hit with second CRL for antifungal treatment, citing manufacturing and API issues

3 years ago

With drug pricing almost done, Congress looks to wrap up FDA user fee legislation

3 years ago

AstraZeneca and Daiichi Sankyo sprint to market after FDA clears Enhertu in just two weeks

3 years ago

FDA's vaccine adcomm to review first fecal transplant to treat C. difficile infections

3 years ago

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

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