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FDA Approves HETLIOZ for Nighttime Sleep Disturbances in Smith-Magenis Syndrome
americanpharmaceuticalreview
December 22, 2020
Vanda Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved HETLIOZ® (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with ...
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Novartis Announces FDA Approval of Xolair for Nasal Polyps
americanpharmaceuticalreview
December 22, 2020
Novartis announced the US Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age ...
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Aeglea Receives FDA Rare Pediatric Disease Designation for Homocystinuria Treatment
americanpharmaceuticalreview
December 22, 2020
Aeglea BioTherapeutics announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to ACN00177 for the treatment of Homocystinuria, a serious metabolic disorder characterized by elevated plasma homocysteine ...
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FDA investigates allergic reactions of Pfizer Covid-19 vaccine in US
pharmaceutical-technology
December 22, 2020
The US Food and Drug Administration (FDA) has started investigating around five allergic reactions that occurred after individuals received Pfizer and BioNTech’s Covid-19 shot.
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Glenmark Pharma gets ANDA tentative approval for Dabigatran Etexilate Capsules
expresspharma
December 22, 2020
It is the generic version of Pradaxa Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim.
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Lupin gets US FDA approval for Rufinamide Oral Suspension
expresspharma
December 22, 2020
It is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in paediatric patients one year of age and older, and in adults.
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GSK gets FDA nod for Benlysta to treat adult patients with active lupus nephritis
pharmaceutical-business-review
December 21, 2020
GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Benlysta (belimumab) to treat adult patients with active lupus nephritis (LN) who are securing standard therapy.
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FDA takes additional action in fight against COVID-19 by issuing Emergency Use Authorization for second COVID-19 vaccine
worldpharmanews
December 21, 2020
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
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Strides gets USFDA nod for Oxybutynin Chloride Tablets
expresspharma
December 21, 2020
Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the United States Food & Drug Administration (USFDA).
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Lupin gets US FDA approval for Colesevelam Hydrochloride Tablets
expresspharma
December 21, 2020
They are indicated for reducing elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.