AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for the company’s treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC).
The U.S. Food and Drug Administration approved ViiV Healthcare’s Cabenuva as the only complete long-acting regimen for the treatment of HIV-1 infection in adults.
The U.S. Food and Drug Administration accepted for review Impel NeuroPharma’s 5O5(b)(2) New Drug Application (NDA) for INP104 for the acute treatment of migraine headaches with or without aura in adults.
Axsome Therapeutics reported positive data from the long-term, open-label Phase III MOVEMENT trial of AXS-07 for the treatment of acute migraine.
A little more than one year after Gilead Sciences Inc. and Galapagos NV announced intentions to seek regulatory approval for Jyseleca (filgotinib) as a treatment for rheumatoid arthritis, the companies pulled the plug on that goal as well as others following a Complete Response Letter issued in August 2020.
Shares of Axsome Therapeutics were up after the company announced positive long-term results from a Phase III major depressive disorder (MDD) study that sets up potential regulatory approval for AXS-05.
The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
The U.S. Food and Drug Administration accepted Copenhagen, Denmark-based Orphazyme’s New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick disease Type C.
The U.S. Food and Drug Administration approved Athena Bioscience LLC’s Qdolo (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
