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GSK and Speros Antibiotic Positive Phase 3 Results

[ Price : $8.95]

GSK and Spero Therapeutics report positive Phase 3 results for tebipenem HBr, an investigational oral antibiotic for complicated u...

FDA Strengthens Tranexamic Acid Warning

[ Price : $8.95]

FDA says it is strengthening labeling for tranexamic acid injection products to clarify that it is only to be administered intrave...

FDA Contracts with ISMP on Medication Errors

[ Price : $8.95]

FDA contracts with the Institute for Safe Medication Practices for services to strengthen its ability to identify and reduce the r...

Workshop on Patch Tests for Allergic Contact Dermatitis

[ Price : $8.95]

FDA hosts a one-day public workshop 10/23 to explore new approaches for approving patch test allergens used in diagnosing allergic...

Replimune BLA Resubmission for Melanoma Therapy

[ Price : $8.95]

FDA accepts for review a Replimune BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating...

Roches Giredestrant Combo Shows Positive Phase 3 Data

[ Price : $8.95]

Roche reports new favorable data from the Phase 3 evERA Breast Cancer study of its investigational oral therapy giredestrant, used...

Cell, Gene Therapy Monitoring Guide Encouraging: Attorneys

[ Price : $8.95]

Attorneys at Hyman, Phelps & McNamara say they are encouraged by an FDA draft guidance outlining a roadmap for postapproval monito...

AdvaMed Proposes MAHA Pathway for Devices

[ Price : $8.95]

The Advanced Medical Technology Association outlines a series of recommendations aimed at strengthening U.S. leadership in medical...

Summits Ivonescimab Outperforms Tislelizumab in Trial

[ Price : $8.95]

Summit Therapeutics reports that its investigational bispecific antibody ivonescimab, when combined with chemotherapy, significant...

FDA Updates Rybelsus Label for CV Risk Reduction

[ Price : $8.95]

FDA approves a new indication for Novo Nordisks Rybelsus (oral semaglutide) tablets to reduce the risk of major adverse cardiovasc...