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FDA Clears First 1-Minute HIV Self Test

[ Price : $8.95]

FDA approves a bioLytical Laboratories PMA for the INSTI HIV Self Test, an at-home HIV test that delivers results in 60 seconds or...

FDA Accepts Chiesis Triple Combination Asthma Inhaler

[ Price : $8.95]

FDA accepts for review a Chiesi NDA for a single-inhaler triple therapy designed for the maintenance treatment of asthma in adults...

Former Deputy Commissioner Bumpus Joins Charles River

[ Price : $8.95]

Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as chair a new global scientific advis...

FDA Warns on RF Microneedling Devices

[ Price : $8.95]

FDA warns of serious complications associated with certain uses of radiofrequency microneedling devices, commonly used in aestheti...

LifeVac Marketing Illegal Airway Device: FDA

[ Price : $8.95]

FDA warns Nesconset, NY-based LifeVac that it is illegally marketing and distributing an airway clearance device.

FDA Accepts NDA for Once-Daily ADHD Drug

[ Price : $8.95]

FDA accepts for review a Cingulate NDA for CTx-1301 (dexmethylphenidate), a once-daily stimulant designed to treat attention-defic...

Astellas Pancreatic Cancer Study Misses Endpoint

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An Astellas Phase 2 study evaluating zolbetuximab in combination with standard chemotherapy for metastatic pancreatic cancer fails...

Leukemia Treatment Data Sets Guidance

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FDA publishes a guidance with recommendations for submitting clinical trial data sets for response assessments for treatments of a...

Pfizers Tukysa Meets Trial Endpoint

[ Price : $8.95]

Pfizer says its Tukysa met the progression-free survival endpoint in the HER2CLIMB-05 breast cancer trial combining Tukysa with st...

FDA Accepts Rockets Gene Therapy BLA Resubmission

[ Price : $8.95]

FDA accepts for review a Rocket Pharmaceuticals BLA resubmission for Kresladi (marnetegragene autotemcel), a gene therapy for seve...