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Human Drugs

Pfizer to Submit Anti-Covid Paxlovid Data to FDA

Pfizer says it will submit full Paxlovid anti-Covid trial data to FDA in a few days.

Human Drugs

Clinical Outcome Assessment Compendium Updated

FDA publishes an updated Clinical Outcome Assessment Compendium.

Human Drugs

Study Shows Viagra Promise in Alzheimers

A Cleveland Clinic study says sildenafil may have a treatment benefit for Alzheimers patients.

Medical Devices

Dentsply Exits Dental Amalgam Market

Anti-dental amalgam activists savor a victory as Dentsply Sirona the worlds largest manufacturer of dental products exits the amalgam market.

Human Drugs

AAM Comments on Controlled Correspondence

The Association for Accessible Medicines says it appreciates an FDA guidance aimed at reducing the controlled correspondence workload.

Human Drugs

Biosimilars Forum, PhRMA Support BsUFA 3

The Biosimilars Forum and PhRMA say they support the third biosimilar user fee agreement negotiated with FDA.

Biologics

Lessons Learned from Gene Therapies: CBER Official

CBER Office of Tissues and Advanced Therapies director Wilson Bryan addresses the lessons learned from FDAs limited experience in approving seven gene...

Biologics

EUA Approved for AstraZenecas Evusheld

FDA issues an emergency use authorization for AstraZenecas Evusheld monoclonal antibody Covid pre-exposure prevention for some adults and pediatric pa...

Human Drugs

Teligent Recalls 2 Topical Lidocaine Lots

Teligent Pharma recalls two lots of lidocaine HCl topical solution USP 4%, 50ml in a screw cap glass bottles, due to internal testing determining the ...

Human Drugs

Gilead Recalls 2 Veklury Lots

Gilead Sciences recalls two lots of Veklury (remdesivir 100 mg for injection) after confirming a complaint about the presence of glass particulates.