MINUTES OF THE 436th REGISTRATION COMMITTEE MEETING HELD ON 28.01.2022 The 436th meeting of the Registration Committee (RC) was held under the…
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Tag:
Approval
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RegulatoryU.S FDA
FDA Investigating Possible Death Risk Linked to TG Therapeutics’ Lymphoma Drug
by adminby adminSynopsis: The U.S. Food and Drug Administration announced it is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib). The drug…
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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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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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AgrochemicalsGlobal Market
Delta Cargo approves the new Envirotainer Releye RLP container for fleet usage
by adminby adminSummary : Delta Cargo announced that it has approved the Envirotainer Releye RLP for usage on their fleet of aircraft. Envirotainer is…
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CompaniesGlobal MarketNovartis
Novartis and Molecular Partners report positive topline data from Phase 2 study for ensovibep (MP0420), a DARPin antiviral therapeutic for COVID-19
by adminby adminSynopsis : Novartis and Molecular Partners announced that Part A of the EMPATHY clinical trial(1) that compared single intravenous doses of ensovibep,…
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Agrochemicals
Amgen and Arrakis Therapeutics announce multi-target collaboration to identify novel RNA degrader small molecule therapeutics
by adminby adminSynopsis : Amgen and Arrakis Therapeutics today announced a research collaboration focused on the discovery and development of RNA degrader therapeutics against…
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Global MarketRegulatoryU.S FDA
Glenmark gets US FDA nod for Nasal Spray to treat seasonal Allergic Rhinitis
by adminby adminSynopsis : With this NDA approval, the company looks forward to bringing this new medicine to physicians and their patients for the…
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Bharat BiotechCompanies
Bharat Biotech seeks full marketing approval from DCGI for Covaxin
by adminby adminSynopsis : Bharat Biotech has sought from the Drugs Controller General of India (DCGI) regular market approval for its COVID-19 vaccine Covaxin’,…
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AgrochemicalsGlobal Market
European Commission approves Cystic Fibrosis Treatment for six to 11-year-olds
by adminby adminSummary : There is currently no cure for cystic fibrosis (CF), a debilitating, progressive condition with over 10,830 people in the UK…