The U.S. Food and Drug Administration approved United Therapeutics Corporation’s Tyvaso (treprostinil) Inhalation Solution for the treatment of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability.
The U.S. Food and Drug Administration approved Takeda Pharmaceutical’s supplemental New Drug Application for Iclusig (ponatinib) for adult patients with chronic-phase chronic myeloid leukemia with resistance or intolerance to at least two prior kinase inhibitors.
U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
The U.S. Food and Drug Administration accepted a New Drug Application and two supplemental NDAs for Genentech’s Xofluza (baloxavir marboxil).
The U.S. Food and Drug Administration issued a Completed Response Letter of Eli Lilly and Boehringer Ingelheim’s Jardiance (empaglifozin) for type 1 diabetes.
The U.S. FDA approved Merck’s supplemental New Drug Application for the use of Zerbaxa for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms.
Merck & Co. announced that the U.S. Food and Drug Administration accepted for review supplemental New Drug Applications (sNDAs) for Pifeltro and Delstrigo.
The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.
An FDA advisory committee voted 6 in favor and 6 against the benefit-risk profile for Pfizer’s Sutent as adjuvant treatment of adults at high risk of recurrent RCC after nephrectomy.
FDA accepted for Priority Review an sNDA for Xarelto for a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy.