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AI Software Authorized for Osteoporosis Screens

[ Price : $8.95]

FDA grants 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aimed at improving osteoporosis sc...

EMA Committee Dismisses GLP-1 Suicidality Risk

[ Price : $8.95]

As FDA continues to evaluate the risk of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists...

FDA Updates Safety Labeling for Envarsus XR

[ Price : $8.95]

FDA approves new safety labeling for Veloxis Pharmaceuticals Envarsus XR (tacrolimus), indicated for use with other medicines to h...

9 Applicants Chosen for Drug Quality Evaluation

[ Price : $8.95]

FDAer Susan Rosencrance tells the agencys Generic Drug Forum that FDA has chosen nine applicants to participate in a Quality Matur...

Kemstro Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that UCBs Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not with...

Vistaril Not Withdrawn Over Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Pfizers Vistaril (hydroxyzine pamoate) oral suspension, 25 mg/5 mL, was not withdrawn...

Oncolytics Wants FDA Meeting on Pelareorep

[ Price : $8.95]

Oncolytics Biotech asks FDA for a 2nd quarter Type C meeting to agree on the design and objectives for a registration-enabling tri...

6 Observations in Cipla FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with six observations from an inspection at the Cipla API and drug manufacturing facility in Ragaid,...

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...