Summary : Johnson & Johnson’s partner, Legend Biotech, has been awarded U.S. Food and Drug Administration approval for its chimeric antigen receptor…
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U.S FDA
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GileadRegulatoryU.S FDA
FDA Rejects Gilead’s Long-Acting HIV Drug Over Vial Issues
by adminby adminSummary : The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Gilead Sciences rejecting its New Drug Application…
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RegulatoryU.S FDA
Aquestive Therapeutics Presented Positive Topline Phase 1 Results for AQST-109 Epinephrine Oral Film at American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting
by adminby adminSummary : Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and…
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RegulatoryU.S FDA
Expert: Newly Appointed FDA Commissioner Robert Califf Is Perfectly Positioned to Advance the FDA’s Accelerated Approval Pathway
by adminby adminSummary : Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, discusses the…
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Summary : Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the…
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RegulatoryU.S FDA
GC Pharma Receives Complete Response Letter From the U.S. FDA For ‘ALYGLO’
by adminby adminSummary : GC Pharma (KRX:006280) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug…
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AstraZenecaCovid DrugsRegulatoryU.S FDA
FDA Adjusts EUA Dosing On Evusheld To Fight Omicron
by adminby adminSummary: The U.S. Food and Drug Administration (FDA) has revised its emergency use authorization (EUA) for AstraZeneca’s Evusheld to a higher dose…
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Summary: The U.S. Food and Drug Administration has approved the use of Purdue Pharma’s candidate injectable treatment for partially or completely reversing…
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CANbridge Pharmaceuticals Inc.CompaniesPharma Science & ResearchRegulatoryU.S FDA
CANbridge Announces Approval of CAN108 for Rare Liver Disease, Alagille Syndrome, Under the Early and Pilot Implementation Policy in Boao Lecheng International Medical Tourism Pilot Zone
by adminby adminSummary : CANbridge Pharmaceuticals, Inc. (“CANbridge”, stock code 1228.HK), a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development…
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Summary : Alejandro Antalich, Chief Executive Officer and Director of Biomind Labs, said: “We are pleased to have obtained our DTC eligibility,…