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Korsuva Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cara Therapeutics Korsuva (...

Cosela Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for G1 Therapeutics Cosela (tr...

Info Collection on Device Shortages Data

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Shortages Data Collections.

Serious Reaction to Some Anti-Seizure Meds: FDA

[ Price : $8.95]

FDA warns of a rare but serious risk of Drug Reaction with Eosinophilia and Systemic Symptoms associated with two anti-seizure dru...

Acelyrin Auditing Izokibep Trial Issues

[ Price : $8.95]

Acelyrin says it will have an independent auditor evaluate contractor research organization issues in trials for its izokibep.

Dr. Bernes Selling Unapproved, Adulterated Eye Drops

[ Price : $8.95]

FDA warns Tesuque, NM-based Dr. Bernes Whole Health Products that it is marketing adulterated unapproved eye drops.

Malignancy Events with CAR T-Cell Therapies: FDA

[ Price : $8.95]

FDA opens an investigation into an identified risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimer...

FDA Warns on Overheating Philips CPAP Devices

[ Price : $8.95]

FDA issues a warning on Philips DreamStation 2 continuous positive airway pressure (CPAP) machines and their potential to overheat...

Biden to use Defense Production Act on Shortages

[ Price : $8.95]

President Biden says his administration will invoke the Defense Production Act to manufacture essential medicines in the U.S. to m...

Public Meeting on Clinical Study Quality

[ Price : $8.95]

FDA and the Duke-Margolis Center for Health Policy announce a hybrid (online/in-person) public meeting 1/31 on Building Quality in...