Cipla gets 6 USFDA observations for Maha facility Ruchika Sharma5 April 2024 11:51 AM ISTMumbai: Cipla has received six inspectional observations in Form 483 from the United States Food and Drug Administration (USFDA) at the...
FDA approves injectable drug for three infections Dr. Kamal Kant Kohli5 April 2024 2:00 AM ISTThe US Food and Drug Administration has approved injectable drug ceftobiprole medocaril sodium (Zevtera) for treatment of Staphylococcus aureus...
USFDA classifies Granules Pharma facility as Voluntary Action Indicated Ruchika Sharma4 April 2024 3:00 PM ISTHyderabad: Granules India has informed in a BSE filing that the United States Food and Drug Administration (USFDA) has classified the facility of...
FDA approves iloperidone for acute treatment of bipolar disorder Dr. Kamal Kant Kohli3 April 2024 10:30 PM ISTThe US Food and Drug Administration (FDA) has granted approval to iloperidone (Fanapt) for acute treatment of bipolar I disorder.Fanapt is an...
Abbott gets USFDA approval for TriClip TEER System for Tricuspid Regurgitation Ruchika Sharma3 April 2024 11:46 AM ISTAbbott Park, III.: Abbott has announced that the U.S. Food and Drug Administration (FDA) has approved the company's first-of-its-kind TriClip...
FDA approves TriClip transcatheter edge-to-edge repair system for treatment of tricuspid regurgitation Dr. Kamal Kant Kohli3 April 2024 5:00 AM ISTThe US Food and Drug Administration has approved First-of-Its-Kind Device, TriClip transcatheter edge-to-edge repair (TEER) system for the treatment...
Abbott gets USFDA clearance for whole blood rapid test to help with assessment of concussion at patient bedside Ruchika Sharma2 April 2024 5:30 PM ISTWith this clearance, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, an advancement since those injured often...
Alembic Pharma gets tentative USFDA nod for breast cancer drug Ribociclib in March Quarter Ruchika Sharma2 April 2024 3:17 PM ISTVadodara: Alembic Pharma has informed in a BSE filing that the Company has received tentative approval for Ribociclib Tablets, 200 mg,...
Lupin bags tentative USFDA nod for Migalastat Capsules Ruchika Sharma2 April 2024 12:30 PM ISTMigalastat Capsules are indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene...
USFDA approves Gilead Sciences Vemlidy sNDA for chronic hepatitis B virus infection in pediatric patients as young as Six Ruchika Sharma30 March 2024 4:15 PM ISTFoster City: Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug...
Roche gets USFDA approval for molecular test to screen for malaria in blood donors Ruchika Sharma30 March 2024 2:30 PM ISTThe cobas Malaria test, a qualitative in vitro nucleic acid screening test, allows for direct detection of Plasmodium RNA and DNA in whole blood...
FDA clears rapid PCR test for sore throat and respiratory infections Dr. Kamal Kant Kohli29 March 2024 6:30 PM ISTThe US Food and Drug Administration has granted 510(k) clearance to bioMerieux for a rapid respiratory/sore throat panel. The test will help...
