Summary : A good news is brewing for kids as the COVID-19 vaccine for the age group younger than 5 years old…
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U.S FDA
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RegulatorySanofiU.S FDA
FDA approves Enjaymo™ (sutimlimab-jome), First Treatment for use in Patients with Cold Agglutinin Disease
by adminby adminSummary : FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease Enjaymo is the only approved treatment…
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Synopsis : The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment…
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RegulatoryU.S FDA
Positive Phase III Data Lifts Madrigal, Hopes for an Effective NASH Treatment
by adminby adminSynopsis : Shares of Madrigal Pharmaceuticals went up in premarket trading after the company announced positive topline data from its Phase III…
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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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Summary : Glenmark Pharmaceuticals on Friday said its US-based unit has received approval from the US health regulator to market Metronidazole Vaginal…
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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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Synopsis : Today, the U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of…
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RegulatoryU.S FDA
Zydus receives final approval from US FDA for Vigabatrin tablets
by adminby adminSummary : Vigabatrin is used to treat babies, one month to two years old with infantile spasms. Zydus has received final approval…
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Global MarketRegulatoryU.S FDA
Swiss drugmaker Idorsia’s insomnia medicine gets US FDA’s approval
by adminby adminSummary : The drug, to be available under the brand name Quviviq, was approved in doses of 25 mg and 50 mg…