Summary : Amgen (NASDAQ:AMGN) and Plexium, Inc. (Plexium) today announced an exclusive, worldwide, multi-year research collaboration and license agreement to identify novel…
FDA
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Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine;…
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Biocon PharmaceuticalCompaniesGlobal Market
Biocon Biologics set to reap Biosimilar Insulin Glargine Opportunity in US
by adminby adminSummary : Drugmaker is banking on the ramp-up of interchangeable biosimilar insulin glargine expecting the product to boost the revenue and profit…
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Global MarketRegulatoryU.S FDA
FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases
by adminby adminSynopsis : The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered…
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AgrochemicalsIndia
Adamis Pharmaceuticals Submits Fast Track Application to FDA for Tempol for the Treatment and Prevention of COVID-19
by adminby adminSynopsis : Adamis Pharmaceuticals Corporation announced the submission of a Fast Track Application to the U.S. Food and Drug Administration (FDA) for…
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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
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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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…