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Vistaril Not Withdrawn Over Safety/Efficacy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Register notice: FDA determines that Pfizers Vistaril (hydroxyzine pamoate) oral suspension, 25 mg/5 mL, was not withdrawn...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

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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

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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

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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

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

Neurovalens Anxiety Device Cleared

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

Drug Shortages at Highest Level: ASHP

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

Califf Defends FDA Role in Patent Listings

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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

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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

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