FDA Newsfeed

… federal Food and Drug Administration (FDA) has classified a series of … request in cooperation with the FDA and were announced on … its initial recall notice, the FDA said no illnesses related to … recorded thus far. Separately, the FDA has issued a recall notice …

… highlights the most impactful FDA decisions from January through … February 14, 2025, the FDA approved the meningococcal ABCWY ( … rates remain low. The FDA approved epinephrine nasal spray … to injectable epinephrine. The FDA approved diazoxide choline extended- …

… serving science, announced the US FDA has approved the Oncomine Dx … of using the newly US FDA approved Genexus Dx Integrated … by Dizal, was granted US FDA accelerated approval following Breakthrough Therapy … at Dizal. “Today’s FDA approval of the Oncomine Dx …

Over 36,000 new cases of multiple myeloma are estimated to be diagnosed in the U.S. in 2025, according to the American Cancer Society |Image used for representational purpose only | Photo Credit: Getty Images Regeneron Pharmaceuticals said on Wednesday the …

… attorneys general are urging the FDA to issue long-overdue guidance … have been prevented. “Had the FDA used the authority they have …

… -based company Tamarack Biotics gained FDA acceptance to treat raw milk … heat," said Comstock. The FDA acceptance is a milestone for …

… .S. Food and Drug Administration (FDA) for the treatment of adults … medical need. Schrödinger (SDGR) Receives FDA Fast Track Designation for Cancer … than traditional methods. With the FDA’s Fast Track status, SGR …

… US Food and Drug Administration (FDA), to restore healthcare resources relating … number of webpages on the FDA and Department of Health and … America, stating that the defendants (FDA, HHS and OPM) violated the …

… – the Food and Drug Administration (FDA) and Mahavitaran (Maharashtra Power Distribution … MLA Vikram Pachpute criticised the FDA, the Shiv Sena MLA Nilesh …

… Pazdur, MD, the FDA Oncology Center of Excellence director … a statement celebrating the FDA’s decision, pointing out … therapy." REFERENCES 1. FDA eliminates risk evaluation and … 47;press-announcements/fda-eliminates-risk-evaluation-and-mitigation …

… S. Food and Drug Administration (FDA). Meijer Inc., a supercenter chain … working hours. Meijer/FDA Why It Matters A Class … remote," according to the FDA. People who have an allergy … as completed, according to the FDA. The agency added that customers …

… March 28, 2025, the FDA approved perioperative durvalumab (Imfinzi … Clarius Mobile Health announced FDA clearance for Clarius Prostate … , Neuspera Medical announced FDA clearance of its integrated … announced that the FDA approved a label expansion …

… has brought several pivotal FDA approvals that are expanding … of the most impactful FDA authorizations shaping clinical practice … in 2025. The FDA approved gepotidacin (Blujepa; GSK … of effective treatment. The FDA granted marketing authorization for …

… powered MR, Philips has received FDA 510(k) clearance for SmartSpeed … of Flash 5100 POC “This FDA clearance is a powerful validation … MRI Speed and Precision with FDA 510(k) Clearance of SmartSpeed … MRI Speed and Precision with FDA 510(k) Clearance of SmartSpeed …

… criticised Maharashtra's FDA, highlighting that banned gutka … Food and Drug Administration (FDA), highlighting the easy accessibility … said. Besides criticising the FDA, he also highlighted its … MLA mentioned that the FDA has requested the General …

… US Food and Drug Administration (FDA) has granted approval for Hikma … new vancomycin is the only FDA-approved product that can be …

… ’s NGS assay receives US FDA approval as companion diagnostic for … US Food and Drug Administration (FDA) has approved the Oncomine™ Dx …

… the associated cybersecurity information that FDA considers generally necessary to … capabilities with connectivity features, FDA is acknowledging the pervasive nature … the Premarket Cybersecurity Guidance. Notably, FDA interprets “related systems” to …

… the ‘2510 IND by the FDA,” said Jamie Freedman, M.D …

… L'AUTORISATION DE LA FDA ET DE L'EMA … ) a été autorisée par la FDA et l'EMA (protocole … de phase 3 par la FDA et l'EMA représente … a été validée par la FDA et l'EMA. L …

PRESS RELEASE MASITINIB RECEIVES FDA AND EMA AUTHORIZATION FOR … AB22007) has been authorized by FDA and EMA (harmonized protocol approved … 3 study by both the FDA and EMA represents a critical … study has been validated by FDA and EMA. The establishment of …

… Radiological Health of the US FDA has designated the SonoClear system … evaluations required for the US FDA 510k submission, as well as … ;With breakthrough designation, the US FDA recognizes a select number of …

… routine testing, according to the FDA. The recall has now been … Class 1 level by the FDA? The agency states that the …

… Dizal Pharmaceutical has received FDA approval for treating patients … Scientific companion diagnostic. The FDA approved both late Wednesday. … cells. Last year, the FDA approved Rybrevant for first- … advantages. Even so, the FDA noted that warnings for the …