Food and Drug Administration (FDA)
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The FDA delayed Bristol Myers Squibb’s (BMS) target date for Reblozyl, approved the company’s melanoma drug and Japan accepted BMS’ NDA for Breyanzi.
Janssen Pharmaceutical’s treatment for people living with human immunodeficiency virus (HIV-1) has received a label update to now include injectable administration.
The FDA approved Pluvicto (targeted radioligand therapy) for use in adults with PSMA-positive mCRPC that has already metastasized to other body parts.
Pfizer issued a statement on Monday regarding a voluntary recall of three of its products. The recall affects eleven lots of hypertension medications in total.
Esai, Biogen, Diadem and ProMis all presented their findings on biomarker research at this year’s International Conference on Alzheimer’s and Parkinson’s Diseases.
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara.
Merck’s Keytruda has become an approved treatment for yet another indication: unresectable or metastatic advanced endometrial carcinoma. Know more about it here.
An FDA Investigational New Drug application has been approved for NeuroSense Therapeutics Ltd.’s PrimeC, a potential therapeutic targeting amyotrophic lateral sclerosis (ALS).
Vallon Pharmaceuticals announced that its Phase III SEAL trial of ADAIR for treatment of ADHD failed to hit its primary endpoint.
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