FDA+ channel feed – Endpoints News

FDA+ channel feed

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Super-speedy cancer drug reviews: FDA unveils new draft guidance to help sponsors apply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

CBO finds Senate's FDA user fee bill will reduce the federal deficit by about $1.4B

3 years ago

Biosimilar inspections still lagging as the FDA looks to clear its backlog

3 years ago

Updated: Spanish heparin manufacturer draws the ire of the FDA in its latest warning over quality concerns

3 years ago

FDA+ roundup: New draft guidance on therapeutic equivalence; Cavazzoni talks accelerated approvals

3 years ago

Without voluntary withdrawals, ODAC to review two more dangling accelerated approvals

3 years ago

MDMA psychotherapy trial put on pause after Health Canada inspection

3 years ago

Incyte nabs second approval with JAK inhibitor cream for vitiligo

3 years ago

Microcap Viking gets a reprieve as FDA lifts hold on PhII study for rare metabolic disorder

3 years ago

Weeks after rare disease drug got spurned, Acer returns to FDA for second shot

3 years ago

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