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Biologics

Prasad Has Covid YouTube Videos Pulled

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

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Human Drugs

Boehringer Gets Breakthrough Status for Hernexeos

FDA grants Boehringer Ingelheim a breakthrough therapy designation for Hernexeos (zongertinib) tablets for the first-line treatment of certain adults ...

Human Drugs

FDA Rare Disease Evidence Principles

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

Biologics

CBER Raising Bar on Future Covid Vaccines

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

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Human Drugs

FDA Accepts NDA for Smoking Cessation Drug

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

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Human Drugs

AI Can Cut Drug Development Costs, Time: Experts

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

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Biologics

Shanghai Henlius Prolia and Xgeva Biosimilars OKd

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

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Human Drugs

Merck PCSK9 Inhibitor Meets Trial Goals

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

Human Drugs

4 Observations in AnazaoHealth Inspection

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

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Human Drugs

FDAs Political Turn Risks Its Core Mission: Expert

FDA policy and regulatory expert Steven Grossman warns that the agencys current trajectory risks undermining its effectiveness by prioritizing politic...