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No Committee for Aquestives Anaphylm

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FDA says an advisory committee is not needed to discuss the Aquestive NDA for Anaphylm to treat severe allergic reactions.

CGMP Violations at Amneal Gujarat, India

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FDA warns Amneal Pharmaceuticals about CGMP violations in its Gujarat, India, drug manufacturing facility.

FDA, CDC Staff Pen Open Letter to Remove RFK Jr.

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Over a thousand current and former staff at FDA, CDC, and NIH pen a new open letter to HHS secretary Robert F. Kennedy Jr. and Con...

Prasad Has Covid YouTube Videos Pulled

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The Guardian says CBER director Vinay Prasad successfully had videos of him criticizing Covid vaccines removed from the YouTube ch...

Boehringer Gets Breakthrough Status for Hernexeos

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FDA grants Boehringer Ingelheim a breakthrough therapy designation for Hernexeos (zongertinib) tablets for the first-line treatmen...

FDA Rare Disease Evidence Principles

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CDER and CBER launch the Rare Disease Evidence Principles process intended to bring greater speed and predictability to the review...

CBER Raising Bar on Future Covid Vaccines

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Memos posted on FDAs Web site from CBER director Vinay Prasad suggest the agency is raising the bar on future Covid-19 vaccination...

FDA Accepts NDA for Smoking Cessation Drug

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FDA accepts for review an Achieve Life Sciences NDA for cytisinicline, an investigational treatment for helping those seeking to q...

AI Can Cut Drug Development Costs, Time: Experts

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Reuters reports that drug manufacturers are turning to artificial intelligence to reduce animal testing and cut costs and time in ...

Shanghai Henlius Prolia and Xgeva Biosimilars OKd

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FDA approves two new denosumab biosimilars from Shanghai Henlius Biotech and Organon for treating osteoporosis and cancer-related ...