Alembic Pharma JV Aleor Dermaceuticals gets USFDA EIR for Karakhadi facility Ruchika Sharma8 May 2020 2:25 PM ISTGujrat: Aleor Dermaceuticals Ltd has received Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA)...
Zydus Cadila gets USFDA final nod for Deferasirox Tablets for Oral Suspension Ruchika Sharma8 May 2020 1:30 PM ISTAhmedabad: Zydus Cadila has received final approval from the USFDA to market Deferasirox Tablets for Oral Suspension in the strengths of 125 mg, 250...
Gilead Sciences unveils plans of expanding global supply of Investigational Antiviral Remdesivir Ruchika Sharma8 May 2020 9:55 AM ISTFoster City: Bagging the USFDA nod for Emergency Use Authorization for remdesivir, maker Gilead sciences, recently announced its plans to increase its...
Diverse Biotech gets orphan-drug designation from USFDA for investigational new therapies in glioblastoma Ruchika Sharma6 May 2020 1:56 PM ISTDoylestown: Diverse Biotech, Inc. has announced the U.S. Food & Drug Administration (FDA) has granted an orphan drug designation request for one...
Alembic Pharma gets USFDA VAI classification for Panelav facility Ruchika Sharma5 May 2020 12:25 PM ISTGujrat: Alembic Pharma has announced that the US Food and Drug Administration (USFDA) has classified the Company's General Oral Solid Formulation...
Aurobindo Pharma gets USFDA nod for Flucytosine Capsules Ruchika Sharma5 May 2020 11:26 AM ISTFlucytosine Capsules are indicated for the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus
USFDA accepts for Priority review Bristol Myers Squibb application for CC-486 for maintenance treatment in leukemia Ruchika Sharma5 May 2020 9:00 AM ISTPrinceton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted it's New Drug Application (NDA) for...
Lupin Announces Positive Topline Results From its Phase 3 Study of Single-Dose Solosec® (secnidazole) in Trichomoniasis Ruchika Sharma4 May 2020 5:54 PM ISTSolosec® is approved by the FDA to treat bacterial vaginosis (BV) in adult women.
Roche gets USFDA emergency use nod for coronavirus antibody test Ruchika Sharma4 May 2020 11:22 AM ISTBasel: Roche has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its new Elecsys®...
Zydus gets USFDA tentative nod for Empagliflozin and Metformin Hydrochloride Tablets Ruchika Sharma2 May 2020 3:41 PM ISTAhmedabad: Zydus Cadila has received tentative approval from the USFDA to market Empagliflozin and Metformin Hydrochloride Tablets, 5 mg/500 mg, 5...
Breaking: USFDA grants Remdesivir Emergency Use Authorization in COVID-19 Treatment Hina Zahid2 May 2020 10:42 AM ISTUSA: In a major development, the U.S. Food and Drug Administration has issued an emergency use authorization for the investigational antiviral...
GSK gets USFDA approval for Ovarian Cancer Drug Zejula Ruchika Sharma2 May 2020 9:30 AM ISTLondon: GlaxoSmithKline plc has announced the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA)...
