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ReShape Lifesciences sPMA for Lap-Band 2.0

[ Price : $8.95]

ReShape Lifesciences files a PMA supplement for the companys next generation Lap-Band 2.0 for long-term treatment of obesity.

FDA Approves Pfizer Alopecia NDA

[ Price : $8.95]

FDA approves a Pfizer NDA for Litfulo (ritlecitinib), a once-daily oral treatment for individuals 12 years of age and older with s...

UCB Psoriasis BLA Review Extended

[ Price : $8.95]

FDA extends its review of UCB's psoriasis drug bimekizumab for reasons the company did not disclose.

CS Medical Ultrasound Probe Cleaner Cleared

[ Price : $8.95]

FDA clears a CS Medical 510(k) for its Ethos Automated Ultrasound Probe Cleaner Disinfector.

Hold Lifted on Pharvaris Angioedema Drug

[ Price : $8.95]

FDA lifts a Pharvaris clinical hold on a deucrictibant clinical trial for the on-demand treatment of hereditary angioedema attacks...

Pfizer Dumps Lotiglipron on Liver Injury Concerns

[ Price : $8.95]

Citing potential liver injury concerns, Pfizer says it is terminating the development program for glucagon-like peptide-1 receptor...

7-Year Echo: Marks Overrode Reviewers on Duchenne Therapy

[ Price : $8.95]

CBER director Peter Marks overrides the review team in the 6/22 accelerated approval of Sarepta Therapeutics Duchenne muscular dys...

Draft Guide on Medical Psychedelic Drugs

[ Price : $8.95]

FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.

Senate FDA Appropriations Bill Includes $20 Million Increase

[ Price : $8.95]

The Senate Appropriations Committee approves FDAs appropriations bill, which provides the agency a $20 million spending increase.

Intercept Hit With 2nd Denial on NASH Drug

[ Price : $8.95]

FDA sends Intercept Pharmaceuticals a second complete response letter on its NDA resubmission for obeticholic acid for treating pr...