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FDA Proposes Accelerated Approval Pathway for Stealth NDA

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FDA issues Stealth BioTherapeutics a complete response letter that proposes the company resubmit its elamipretide NDA to seek acce...

Alcon Dry Eye Drug Tryptyr Approved

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FDA approves an Alcon NDA for Tryptyr (acoltremon ophthalmic solution) 0.003% for treating the signs and symptoms of dry eye disea...

Former McKinsey Partner Sentenced for Purdue Work

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Former McKinsey & Company senior partner Martin Elling is sentenced to six months in federal prison, supervised release after inca...

Promising Trial Results for Wegovy Add-on: Veru

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Veru announces positive topline results from its Phase 2b QUALITY clinical trial that is evaluating enobosarm when added to semagl...

Mitsubishi Tanabe Resubmits NDA for Parkinsons Combo

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FDA accepts for review a Mitsubishi Tanabe Pharma America NDA resubmission for investigational ND0612, a continuous, subcutaneous ...

Zhejiang Huahai FDA-483 Released

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FDA releases the form FDA-483 with seven observations from a January inspection at Chinas Zhejiang Huahai Pharmaceuticals.

Multiple Issues at Germanys DRG Instruments

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FDA warns Marburg, Germany-based DRG Instruments that it is marketing diagnostic devices that do not have FDA approval and are bei...

House Democrats Want Answers on HHS Staff Cuts

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Complaining about a lack of information from the department, top Democrats on the House Energy and Commerce Committee ask HHS Secr...

FDA Publishes 2 Q-Submission Guidances

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FDA publishes two guidances relating to the CDRH/CBER Q-submission process.

GSK Plans for Antibiotic NDA in 2nd Half

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GSK plans to submit an NDA in the second half of the year after it and Spero Therapeutics announced that they will end their Phase...