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Browsing Tag
US FDA
US doctor develops severe allergic reaction to Moderna COVID-19 vaccine, reports NYT
It is the first severe reaction publicly linked to Moderna’s vaccine, which is in its first week of rollout in the US
USFDA defers action on BLA for Avastin biosimilar, notifies Biocon Biologics, Mylan
To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the…
Lupin gets US FDA approval for Rufinamide Oral Suspension
It is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in paediatric patients one year…
Glenmark Pharma gets ANDA tentative approval for Dabigatran Etexilate Capsules
It is the generic version of Pradaxa Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim
US FDA declines approval for Novartis’ inclisiran
The drug regulator cited unresolved facility inspection issues for denying approval
US FDA gives EUA to Moderna’s mRNA vaccine against COVID-19
Total of 200 million doses ordered by the US government to date, approximately 20 million doses will be delivered by the end of…
Lupin gets US FDA approval for Colesevelam Hydrochloride Tablets
They are indicated for reducing elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia
Strides gets USFDA nod for Oxybutynin Chloride Tablets
They are used to treat overactive bladder and urinary conditions
US FDA Advisory Committee supports EUA for Moderna’s COVID-19 vaccine
The primary analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1 per cent