Less than one month after the U.S. Food and Drug Administration raised concerns about the supplemental New Drug Application for Pfizer and Myovant Sciences’ Myfembree (relugolix), the regulatory agency extended the review period to Aug. 6. The initial approval review date was May 6.
Incyte Corporation reported that the U.S. Food and Drug Administration pushed back the review of the company’s supplemental New Drug Application for Opzelura (ruxolitinib cream) for vitiligo.
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.