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Roche Alzheimers Test is Breakthrough Device

[ Price : $8.95]

FDA grants breakthrough device designation to a Roche blood test intended to aid in a diagnosis of Alzheimers disease based on amy...

Fasenra OKd for Pediatric Severe Asthma

[ Price : $8.95]

FDA approves an AstraZeneca supplemental BLA for Fasenra (benralizumab) as an add-on maintenance treatment for patients with sever...

Neurovalens Anxiety Device Cleared

[ Price : $8.95]

FDA clears a Neurovalens 510(k) for the Modius Stress and its use to treat generalized anxiety disorder.

Drug Shortages at Highest Level: ASHP

[ Price : $8.95]

The American Society of Health-System Pharmacists says drug shortages are at the highest level since 2001.

Califf Defends FDA Role in Patent Listings

[ Price : $8.95]

During a 4/11 hearing , U.S. Representative Ro Khanna (D-CA) criticizes FDA and commissioner Robert Califf for not doing enough to...

Appeals Court Upholds Norwich ANDA Delay

[ Price : $8.95]

A federal appeals court affirms a lower court decision barring FDA from approving a Norwich ANDA for a generic form of Salix Xifax...

FDA OKs CAR-T Trial in Children for Lupus

[ Price : $8.95]

FDA authorizes Seattle Childrens Therapeutics to launch a CAR T-cell trial to treat lupus in children.

Army Scientific Groups Hemorrhage AI Detector Cleared

[ Price : $8.95]

FDA clears a U.S. Army Biotechnology High Performance Computing Software Applications Institute 510(k) for an artificial intellige...

Lisata Orphan Status for Osteosarcoma Drug

[ Price : $8.95]

FDA grants Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma.

Italfarmaco Awarded Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA issues a priority review voucher to Italfarmaco SpA for being the sponsor of a rare pediatric disease...