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Alembic Pharmaceuticals gets USFDA nod for Fenofibrate Capsules
expresspharma
October 22, 2020
They are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia, mixed dyslipidemia and hypertriglyceridemia.
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Xeris Pharma gets US FDA fast track designation for diazepam non-aqueous injection to treat acute repetitive seizures
expresspharma
October 22, 2020
It was previously granted orphan designations both for the treatment of acute repetitive seizures and for the treatment of Dravet Syndrome.
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Aleor Dermaceuticals gets USFDA nod for Tavaborole Topical Solution
expresspharma
October 22, 2020
It is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
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Edesa Biotech gets FDA approval for EB05 trial to treat Covid-19
pharmaceutical-technology
October 22, 2020
Biopharma firm Edesa Biotech has received clearance from the US Food and Drug Administration (FDA) to initiate the Phase II part of Phase II / III clinical trial of its investigational drug EB05 to treat hospitalised patients with Covid-19.
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FDA accepts review for ANGLE’s Parsortix system for metastatic breast cancer
pharmatimes
October 22, 2020
Liquid biopsy company ANGLE has announced that the US Food and Drug Administration has accepted its submission for substantive review of its Parsortix system for use with metastatic breast cancer (MBC) patients.
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Zydus Cadila gets tentative USFDA nod for Tofacitinib ER tablets
expresspharma
October 21, 2020
Zydus Cadila has received tentative approval from the USFDA to market Tofacitinib Extended-Release Tablets, 11 mg (US RLD: Xeljanz XR Tablets).
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Glenmark Pharma receives USFDA approval for Sirolimus tablets
expresspharma
October 21, 2020
These tablets are the generic version of Rapamune Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV.
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FDA Accepts sNDA Of NURTEC ODT for Preventive Treatment of Migraine
americanpharmaceuticalreview
October 21, 2020
Biohaven Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has filed and accepted for review its recently submitted supplemental New Drug Application (sNDA) for NURTEC™ ODT (rimegepant) for the preventive treatment of migraine.
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FDA Grants ODD for Esophageal, Gastroesophageal Junction, Pancreatic Cancer Treatment
americanpharmaceuticalreview
October 21, 2020
Apexigen announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation status to APX005M for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer.
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Harmony Biosciences Receives FDA Approval for Expanded Use of WAKIX
americanpharmaceuticalreview
October 21, 2020
Harmony Biosciences announced the U.S. Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy.