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Aleor Dermaceuticals gets US FDA nod for Adapalene Gel USP
expresspharma
June 22, 2020
It is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
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US FDA grants approval to Ultragenyx Pharmaceutical for Crysvita
expresspharma
June 22, 2020
The drug has been approved to treat patients with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones.
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US FDA declines approval again for Nabriva’s antibiotic for UTI
expresspharma
June 22, 2020
The company said it plans to request a meeting with the FDA to discuss the next steps.
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FDA Issues EUA to HymonSARS-CoV-2 Test Kit for Detection of COVID-19
contractpharma
June 19, 2020
SpectronRx and HymonBio expect to produce 10 million tests per month for labs around the world.
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OPQ Issues the 2019 Report on the State of Pharmaceutical Quality
americanpharmaceuticalreview
June 18, 2020
The Office of Pharmaceutical Quality (OPQ) within the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research has published its 2019 Report on the State of Pharmaceutical Quality.
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Immunic Announces FDA Allowance of IMU-838 Trial
americanpharmaceuticalreview
June 18, 2020
Immunic announced receipt of regulatory allowance from the U.S. Food and Drug Administration (FDA) to initiate its phase 2, CALVID-1 clinical trial of IMU-838, the company's selective oral DHODH inhibitor, in coronavirus disease 2019 (COVID-19) at centers
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Agios Announces FDA Orphan Drug Designation Granted to Mitapivat for Treatment of Thalassemia
americanpharmaceuticalreview
June 18, 2020
Agios Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s first-in-class pyruvate kinase-R (PKR) activator mitapivat for the treatment of patients with thalassemia.
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US FDA approves Novartis’s Ilaris for Active Still’s disease treatment
expresspharma
June 18, 2020
Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
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NeoImmuneTech receives FDA orphan drug designation for NT-I7 to treat Progressive Multifocal Leukoencephalopathy
pharmaceutical-business-review
June 17, 2020
NeoImmuneTech, a clinical-stage T cell-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NeoImmuneTech’s NT-I7 (efineptakin alfa) ...
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Insmed Receives FDA Breakthrough Therapy Designation for Non-Cystic Fibrosis Bronchiectasis Treatment
americanpharmaceuticalreview
June 17, 2020
Insmed announced the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for brensocatib (formerly known as INS1007) for the treatment of adult patients with non-cystic fibrosis bronchiectasis (NCFBE) for reducing ...