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EUA for Covid-19 Breathalyzer

[ Price : $8.95]

FDA grants InspectIR an emergency use authorization for the first Covid-19 diagnostic test that detects Covid-19 chemical compound...

Guide on ANDA Waivers for pH Adjusters

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Considerations for Waiver Requests for pH Adjusters in Gene...

Guide on Animal Drug Compounding

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on Compounding Animal Drugs from Bulk Drug Substances.

High Immune Response in Pfizer Booster in Kids

[ Price : $8.95]

Pfizer says it and BioNTech will request an FDA emergency use authorization for a Covid vaccine booster shot for children ages 5-1...

NDA, IND Bioavailability Studies Guidance

[ Price : $8.95]

FDA publishes a guidance to help sponsors submit bioavailability information for specified drug products in INDs and NDAs.

Draft Guide on Trial Diversity Plans

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Diversity Plans to Improve Enrollment of Participants from ...

Massive Judgment Against Ethicon Upheld

[ Price : $8.95]

A California appeals court upholds $302 million of a $344 million trial court judgment against Ethicon over misleading communicati...

FDA Breakthrough Rescission on Protagonists Rusfertide

[ Price : $8.95]

FDA tells Protagonist Therapeutics that it intends to rescind the companys breakthrough therapy designation for rusfertide and its...

Merck Gets Breakthrough on Pneumococcal Vaccine

[ Price : $8.95]

FDA grants Merck a breakthrough therapy designation for V116, an investigational 21-valent pneumococcal conjugate vaccine.

AbbVie, Genmab Contacting Regulators on Cancer Drug

[ Price : $8.95]

AbbVie and Genmab say they will open regulatory discussions on their investigational cancer drug epcoritamab, based on Phase 1/2 t...