Omeros stops the development of narsoplimab for treating immunoglobulin A nephropathy based on Phase 3 clinical trial data that did not show statistic...
AbbVie reports positive results from the head-to-head Phase 3 SEQUENCE study that evaluated the efficacy and safety of its Skyrizi (risankizumab) comp...
FDA publishes a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol.
FDA posts a draft guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.
Federal Register notice: FDA determines that Sandozs Zofran ODT (ondansetron) orally disintegrating tablets (4mg and 8mg) were not withdrawn due to sa...
Aldeyra Therapeutics says it is addressing substantive late review-cycle concerns raised by FDA on the companys NDA for reproxalap for treating dry ey...
An FDA update says GE HealthCare preliminary testing on its newly manufactured neonatal incubators suggests they may have higher levels of formaldehyd...
FDA accepts for priority review an AstraZeneca supplemental NDA for Tagrisso (osimertinib) in combination with chemotherapy for treating certain adult...
