FDA+ channel feed – Endpoints News

FDA+ channel feed

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Super-speedy cancer drug reviews: FDA unveils new draft guidance to help sponsors apply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FDA+ roundup: New draft guidance on therapeutic equivalence; Cavazzoni talks accelerated approvals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

Pfizer celebrates a new FDA approval as the Xalkori franchise slowly winds down

3 years ago

Pfizer's Hospira issues a recall for a batch of propofol due to a visible particulate

3 years ago

FDA user fee bill deadline falls apart? Thousands of pink slips for FDA could be coming as Burr seeks to start anew

3 years ago

Drug shortages remain low in 2021 as FDA's prevention efforts grow, report to Congress says

3 years ago

Novartis’ $650M cash bet on a near-term FDA OK for BeiGene’s China PD-1? It just got delayed indefinitely

3 years ago

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