Synopsis : With this NDA approval, the company looks forward to bringing this new medicine to physicians and their patients for the…
U.S FDA
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RegulatoryU.S FDA
USFDA approval for Marksans Pharma Cetirizine Hydrochloride Tablets
by adminby adminSummary : Marksans Pharma Limited (Reuters: MARK.BO; Bloomberg: MRKS IN; NSE: MARKSANS; BSE: 524404) has received final approval from US Food &…
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Global MarketRegulatoryU.S FDA
US FDA clears Jubilant Therapeutics’ IND for novel dual LSD1 & HDAC6 inhibitor, JBI-802 for treatment of solid tumours
by adminby adminSynopsis: Jubilant Therapeutics Inc, a biopharmaceutical company, announced US Food and Drug Administration (FDA) clearance of the investigational new drug application (IND)…
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RegulatoryU.S FDA
US FDA approves expanded MRI compatibility for Abbott’s Proclaim XR Spinal Cord Stimulation System
by adminby adminSummary : -Abbott, a global healthcare leader, announced that the US Food and Drug Administration (FDA) has approved new expanded magnetic resonance…
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RegulatoryU.S FDA
Xeris Biopharma scores FDA approval for endogenous Cushing’s syndrome drug Recorlev
by adminby adminSynopsis -Ahead of its New Year’s Day decision deadline at the FDA, Xeris Biopharma has snagged an approval for Recorlev, a drug…
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RegulatoryU.S FDA
Granules India Ltd gets USFDA nod for its Generic Amphetamine Mixed Salts
by adminby adminSummary : Granules India on Thursday said it has received approval from the US health regulator for its generic Amphetamine mixed salts…
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RegulatoryU.S FDA
Roche COVID-19 At-Home Test Granted FDA Emergency Use Authorization to expand access to Rapid Self-Testing Solutions in the United States
by adminby adminSummary : Rapid test to support the American public’s fight against the COVID-19 pandemic, with availability to purchase over-the-counter (OTC) at pharmacies…
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CompaniesNovartisRegulatoryU.S FDA
Novartis Cosentyx® Receives FDA Approval for the Treatment of Children and Adolescents with Enthesitis-Related Arthritis and Psoriatic Arthritis
by adminby adminSummary : -New approvals are based on JUNIPERA trial data showing Cosentyx® (secukinumab) demonstrated reduced flare risk versus placebo and improvement in…
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RegulatoryU.S FDA
FDA IND Application Clearance to Hepion Pharma for its CRV431 in the Treatment of Liver Cancer
by adminby adminSummary – New IND Expands Liver Disease Pipeline for CRV431 IND Clearance Allows CRV431 to Move Directly into Phase 2 for Hepatocellular…
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RegulatoryU.S FDA
Aquestive Therapeutics Receives Notification from FDA for the Company’s NDA for Libervant™ (diazepam) Buccal Film
by adminby adminSynopsis : Received notification to Review of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the treatment of breakthrough…