Summary : Alembic Pharmaceuticals received a tentative approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug…
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Category:
Regulatory
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Agro Science & ResearchLaunch
Syngenta introduces Postiva™ fungicide, a new product.
by adminby adminSummary : With the registration of Syngenta’s PostivaTM fungicide, ornamental producers now have a powerful tool to assist manage challenging diseases like…
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RegulatorySanofi Inc.U.S FDA
Nexviazyme® improves respiration and mobility long-term in Pompe disease patients
by adminby adminSummary : Two-year data shows Pompe disease patients treated with Nexviazyme® (avalglucosidase alfa) have sustained improvements in respiratory function and mobility. Sanofi has…
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CompaniesCovid DrugsModernaPfizerRegulatoryU.S FDA
Moderna and Pfizer are Well-Positioned to Take mRNA into the Future
by adminby adminSummary : It’s an understatement to note that the bottom lines for Moderna and Pfizer have been fattened by the success of…
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Covid DrugsRegulatoryU.S FDA
Ocugen Ends Week on Low as FDA Rejects Covaxin EUA for Kids
by adminby adminSummary : The U.S. Food and Drug Administration turned down Ocugen’s Emergency Use Authorization (EUA) request for Covaxin in children 2 to…
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Lupin PharmaRegulatoryU.S FDA
Lupin launches Sevelamer Hydrochloride tablets in the United States used in treatment of kidney disease
by adminby adminHighligts : Sevelamer Hydrochloride Tablets, 800 mg is a generic equivalent of Renagel Tablets, 800 mg of Genzyme Corporation used in the…
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RegulatoryU.S FDA
J&J, Legend Introduce New CAR-T Therapy to Multiple Myeloma Market
by adminby adminSummary : 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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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…