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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 ...

CGMP Issues at Compounders International

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FDA warns Castle Rock, CO-based Compounders International Analytical Laboratory about CGMP violations and deviations in its work t...

FDA Publishes OTC Drug Monograph Forecast

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FDA publishes the 2025 OTC drug monograph forecast showing eight items it expects to address over the next three years.

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 ...

Merck PCSK9 Inhibitor Meets Trial Goals

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Merck says its oral PCSK9 inhibitor met all primary and secondary endpoints in the CORALreef Lipids Phase 3 trial.

4 Observations in AnazaoHealth Inspection

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FDA releases the form FDA-483 with four observations from an inspection at the Las Vegas, NV-based AnazaoHealth compounding facili...