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ANDA Physicochemical/Structural Characterization Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Physicochemical and Structural (Q3) Characterization of Top...

Tremfya 80% Response Rate in Ulcerative Colitis: Janssen

[ Price : $8.95]

Janssen Pharmaceutical says new data show that patients given Tremfya (guselkumab) saw a clinical response rate of about 80% in tr...

FDA Explains Why Zepzelca Will Not be Withdrawn

[ Price : $8.95]

Responding to a petition seeking the removal of approval for Jazz Pharmaceuticals lung cancer drug Zepzelca, FDA explains why it d...

FDA Approves Biologic for Some Myelomas

[ Price : $8.95]

FDA gives accelerated approval to Janssens teclistamab-cqyv for some adults with relapsed or refractory multiple myeloma.

FDA Airs Daprodustat Safety Concerns

[ Price : $8.95]

FDA medical reviewers tell members of the Cardiovascular and Renal Drugs Advisory Committee there are safety concerns with GlaxoSm...

ANDA In Vitro Release Test Studies Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled In Vitro Release Test Studies for Topical Products Submitte...

Guidances on ANDA Bioequivalence for Topicals

[ Price : $8.95]

Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for developing topical ...

FDA Nixes Cefazolin as Surrogate Agent for Cephalosporins

[ Price : $8.95]

FDA determines there are insufficient data to support a proposed cefazolin susceptible minimum inhibitory concentration breakpoint...

Warning Letter Close Out for Innova Medical

[ Price : $8.95]

FDA closes out a Warning Letter issued to Innova Medical Group over its unauthorized Covid-19 test following a recent inspection t...

Gene Therapy Neurodegenerative Disease Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Human Gene Therapy for Neurodegenerative Diseases; Guidance...