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MSN group gets US FDA nod for dimethyl fumarate capsules
expresspharma
October 10, 2020
Dimethyl fumarate is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults.
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BMS’ Opdivo combo gets FDA approval for malignant pleural mesothelioma
pharmaceutical-technology
October 10, 2020
The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb (BMS)’s Opdivo (nivolumab) plus Yervoy (ipilimumab) for treating adults with unresectable malignant pleural mesothelioma (MPM).
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Amphastar Receives FDA Approval for Atropine Sulfate Injection
americanpharmaceuticalreview
October 10, 2020
Amphastar Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved the Company’s Abbreviated New Drug Application (ANDA) for Atropine Sulfate injection 0.1mg/mL in the 10 mL Luer-Jet® Prefilled Syringe System.
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FDA Considers Withdrawing Makena Approval
americanpharmaceuticalreview
October 10, 2020
AMAG Pharmaceuticals has received a notice from the U.S. Food and Drug Administration (FDA) that the FDA is proposing to withdraw approval of Makena® (hydroxyprogesterone caproate injection).
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Pfizer get USFDA nod for XELJANZ (tofacitinib) to treat active polyarticular course juvenile idiopathic arthritis
expresspharma
October 09, 2020
Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight.
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FDA Approves First Drug to Treat Group of Rare Blood Disorders
americanpharmaceuticalreview
October 09, 2020
The U.S. Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the ...
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FDA Authorizes First Point-of-Care Antibody Test for COVID-19
americanpharmaceuticalreview
October 09, 2020
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.
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FDA Approves Bausch + Lomb Alaway Preservative Free Ophthalmic Solution
americanpharmaceuticalreview
October 09, 2020
Bausch Health, Bausch + Lomb, and Eton Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Alaway® Preservative Free (ketotifen fumarate) ophthalmic solution, 0.035%, antihistamine eye drops (EM-100) ...
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Lupin launches atorvastatin calcium tablets
expresspharma
September 30, 2020
It is indicated to lower cholesterol in blood for adults and children over 10 years of age.
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Anokion announces FDA clearance of IND application for ANK-700 to treat multiple sclerosis
pharmaceutical-business-review
September 30, 2020
Anokion SA announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for ANK-700, an antigen-specific drug candidate for the treatment of multiple sclerosis (MS).