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Panel to Weigh OTC Phenylephrine Efficacy

[ Price : $8.95]

FDA announces a 4/12 Nonprescription Drugs Advisory Committee meeting to discuss the adequacy of efficacy data available for over-...

Incyte Abandons Phase 3 Myelofibrosis Trial

[ Price : $8.95]

An unfavorable interim analysis leads Incyte to discontinue the Phase 3 LIMBER-304 myelofibrosis trial due to efficacy concerns.

Panel on Knee Meniscus Implant

[ Price : $8.95]

Federal Register notice: FDA announces a 4/20 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committe...

Notice on Biosimilar Patent Infringement Complaint

[ Price : $8.95]

Federal Register notice: FDA provides notice that is has received a copy of a patent infringement complaint that had been filed ag...

FreeStyle Sensors for Automated Insulin Delivery

[ Price : $8.95]

FDA clears an Abbott 510(k) for its FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring system sensor...

FDA Increasing Oversight on Diethylene Glycol Contamination

[ Price : $8.95]

CDER director Patrizia Cavazzoni says the agency is stepping up its actions to prevent contaminated drug products, including cough...

Novartis Petitions FDA on Dosing Titration Info Requirement

[ Price : $8.95]

Presumably in an attempt to block or delay potential generic Mayzent products, Novartis petitions FDA to make generic versions mee...

Exelixis Renal Cell Carcinoma Study Misses Endpoint

[ Price : $8.95]

Exelixis says its Phase 3 CONTACT-03 study evaluating the companys Cabometyx (cabozantinib) in combination with atezolizumab versu...

Drug Continuous Manufacturing Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Q13 Continuous Manufacturing of Drug Substances and Drug Pr...

Guide on Monoclonal Antibody Development

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Potency Assay Considerations for Monoclonal Antibodies and ...