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FDA Warns Apotex Canadian Manufacturing Site

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FDA issues a Warning Letter to Apotex, citing significant GMP violations at the companys Richmond Hill, Ontario, facility, includi...

Sydnexis Pediatric Myopia Drug Meets Endpoints

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Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase...

Can Industry Accept a Dysfunctional FDA?: Axios

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An Axios report following the resignation of CDER director George Tidmarsh questions how much more agency dysfunction industry can...

Sarepta Completes Confirmatory Duchenne Trial

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Sarepta Therapeutics reports mixed data from its Phase 3 ESSENCE confirmatory study evaluating its Duchenne muscular dystrophy dru...

Compass Pathways Speeds COMP360 Launch

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Compass Pathways says it expects to be able to launch its COMP360 psilocybin treatment for treatment-resistant depression nine to ...

Otsuka ICU Recalls Mislabeled Potassium Chloride Injection

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Otsuka ICU Medical recalls (Class 1) one lot of its potassium chloride injection, 20 mEq, after discovering that the overwrap labe...

FDA OKs Aqua Medical IDE for Endoscopic Technology Trial

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FDA gives investigative device exemption approval for an Aqua Medical pilot clinical trial of its Proximal Intestinal Mucosal Abla...

Reforms Needed to Boost Efficiency of Global Cancer Trials: Report

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A new report from the Reagan-Udall Foundation calls for broad operational and policy reforms to improve the efficiency, representa...

FDA OKs Meitheals Antibiotic for Urinary Tract Infections

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FDA approves a Meitheal Pharmaceuticals NDA for Contepo (fosfomycin) for injection for treating adults with complicated urinary tr...

FDA Lifts Hold on Rein Pulmonary Fibrosis Trial

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FDA lifts a clinical hold against the Rein Therapeutics Phase 2 RENEW trial evaluating LTI-03 in patients with idiopathic pulmonar...