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Ocugen EUA Declined for Covid Vaccine

[ Price : $8.95]

FDA declines to grant Ocugen an emergency use authorization for Covaxin for active immunization to prevent Covid-19 in individuals...

Patrick Bishop Debarred for 5 Years

[ Price : $8.95]

Federal Register notice: FDA issues an order to debar Patrick Charles Bishop for a period of five years from importing or offering...

Sanofi Petitions FDA to Add Study Failure in Fluad Labeling

[ Price : $8.95]

Sanofi petitions FDA to mandate a labeling change to Seqirus influenza vaccine products Fluad and Fluad Quadrivalent to reflect th...

CDER Updates Rare Disease Efforts

[ Price : $8.95]

A CDER online post updates the Centers efforts to support rare disease drug development, particularly through data sharing initiat...

GC Pharma Complete Response on Immune Globulin

[ Price : $8.95]

FDA issues South Korea-based GC Pharma a complete response letter on its BLA for GC5107 (immune globulin intravenous (human), 10% ...

Guide on Timely Product Recalls

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpar...

FDA Debars George Kuiper for 5 Years

[ Price : $8.95]

Federal Register notice: FDA debars George Kuiper for a period of five years from importing or offering for import any drug into t...

DexCom Breakthrough Status for Glucose Monitor

[ Price : $8.95]

FDA grants DexCom a breakthrough device designation for its Dexcom real-time continuous glucose monitoring system for use in the h...

Senators Ask CMS Not to Hurt Alzheimers Drug Access, Research

[ Price : $8.95]

Sens. Collins and Capito ask the Centers for Medicare and Medicaid Services to ensure that its national coverage decision on Aduhe...

FDA Extends Review of TG Therapeutics Submissions

[ Price : $8.95]

FDA extends by three months its review of a TG Therapeutics BLA and supplemental NDA for ublituximab in combination with Ukoniq (u...