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Keytruda sBLA for Biliary Tract Cancer

[ Price : $8.95]

FDA accepts for review a Merck supplemental BLA for Keytruda in combination with standard-of-care chemotherapy for treating patien...

Avita Skin Defect Device Get Expanded Use

[ Price : $8.95]

FDA approves an Avita Medical PMA supplement for use of its Recell System to treat full-thickness skin defects.

Buspar Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Bristol Myers Squibbs Buspar (buspirone HCl) was not withdrawn due to safety or effec...

Info Collection Extension of Drug Import Plans

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Importation of Prescription Drugs 21 ...

Antimicrobial Drugs Panel Renewed

[ Price : $8.95]

Federal Register notice: FDA renews its Antimicrobial Drugs Advisory Committee for an additional two years.

FDA Taps Murphy to Head Generic Drugs Office

[ Price : $8.95]

FDA names CDER Office of Generic Drugs safety and clinical evaluation acting director Iilun Murphy as the next OGD director, repla...

FDA Approves Production at BMS CAR T Facility

[ Price : $8.95]

FDA greenlights commercial production of CAR T cell therapy at a new Bristol Myers Squibb manufacturing site in Devens, MA.

Panel Backs RSV Monoclonal Antibody

[ Price : $8.95]

FDAs Antimicrobial Drugs Advisory Committee votes unanimously that AstraZeneca and Sanofis nirsevimab has a favorable benefit-risk...

FibroGens Pamrevlumab Fails Phase 3

[ Price : $8.95]

FibroGen says its pamrevlumab failed to meet the primary endpoint in treating Duchenne Muscular Dystrophy in a Phase 3 trial.

AdvaMed Recommendations for Patient Preference

[ Price : $8.95]

AdvaMed says it agrees with FDA on questions to be added to a guidance on the submission of patient preference information, and al...