Deciphera Pharmaceuticals announced that the European Commission (EC) has approved Qinlock (ripretinib) in the European Union (EU) for the treatment of adult patients with advanced gastrointestinal stromal tumor… read more.
AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA clearance as a Class II… read more.
Swedish Orphan Biovitrum AB (publ) (Sobi) and Apellis Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted… read more.
Moderna, Inc. provided an update that the FDA has notified the Company that it will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA)… read more.
Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred… read more.
Allergan announced the FDA approval of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. Vuity is… read more.
Horizon Therapeutics announced topline results of the phase III MIRROR trial met the primary endpoint, showing a significant increase in efficacy using Krystexxa (pegloticase injection) with the immunomodulator… read more.
-Moderna Inc. announced positive interim data from the Phase II/III study, called the KidCOVE study, of mRNA-1273 , the Company’s vaccine candidate against COVID-19, in children 6 to… read more.
Radius Health announced positive topline results from the ATOM study evaluating Tymlos (abaloparatide) 80mcg subcutaneous (SC) for use in males with osteoporosis. The ATOM study met its primary… read more.
Novartis is pleased to announce that eligible patients in England and Wales will soon have routine access to Adakveo (crizanlizumab) under a Managed Access Agreement (MAA). The news… read more.
Moderna, Inc. confirmed that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose… read more.
Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing… read more.
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