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2nd Generic Mifepristone Approved, Prompting Backlash

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FDA approves the second generic copy of abortifacient mifepristone, a move that prompted mixed reactions from lawmakers and advoca...

Agency Posts Form-483 for India Vaccine Maker

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FDA posts a five-item FDA Form-483 after inspecting Covid-19 vaccine maker Serum Institute of Indias Maharashtra manufacturing fac...

Rocket Pharma Withdraws Gene Therapy BLA

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Rocket Pharmaceuticals withdraws its BLA for RP-L102 (mozafancogene autotemcel), an investigational gene therapy for treating Fanc...

Repatha Phase 3 Trial Hits Primary Endpoints

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Amgen says its Repatha met the primary endpoints in a landmark Phase 3 trial, making it the only PCSK9 inhibitor to demonstrate a ...

Grifols Barcelona Facility Gets FDA-483

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FDA posts a four-item Form FDA 483 that was issued to Laboratorios Grifols after a 7/2024 inspection of the firms drug manufacturi...

sBLA for Enhertu in High-Risk Early Breast Cancer

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FDA accepts for review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu use followed by paclitaxel, trastuzumab, and ...

FDA Approves Combo for Lung Cancer Maintenance

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FDA approves Jazz Pharmaceuticals Zepzelca (lurbinectedin) in combination with Genentechs Tecentriq or Tecentriq Hybreza for the m...

FDA Grants Fast Track for Alzheimers Drug

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FDA grants Bristol Myers Squibb fast-track status for its investigational Alzheimers therapy BMS-986446.

FDA Touts Sentinel Successes

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FDA issues a report highlighting Sentinel System activities and achievements between 2022 and 2024.

FDA, Vanda Agree on Dispute Actions

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FDA and Vanda agree to a series of actions to resolve their disputes over the companys Hetlioz and tradipitant.