After discussions with the FDA, Applied Therapeutics Inc. said it will again delay an NDA filing for its galactosemia treatment, AT-007, until it has more time to discuss the filing with the agency.
Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA.
Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA. The drug has been approved in Korea to treat relapsed or refractory multiple myeloma (MM) and relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with dexamethasone.
An ongoing FDA review of Iterum Therapeutics plc's NDA for a bilayer tablet containing sulopenem etzadroxil and probenecid for uncomplicated urinary tract infections (uUTI) has uncovered "deficiencies that preclude the continuation" of talks on labeling and postmarketing requirements, the company said. The revelation, less than four weeks before the NDA's July 25 PDUFA date, "throws an on-time approval into serious doubt," making Iterum's receipt of a complete response letter "a reasonably likely scenario," H.C. Wainwright analyst Ed Arce wrote.
The FDA has accepted Eyenovia Inc.’s new drug application (NDA) for Mydcombi, a fixed combination pupil dilation agent, with a PDUFA date of Oct. 28, 2021.
Mycovia Pharmaceuticals Inc. said new phase III data on its oral antifungal, oteseconazole, showed that 37 weeks after women with a history of recurrent vulvovaginal candidiasis received a dose of the medicine for an episode of acute yeast infection, just 5.1% saw a recurrence of infection vs. 42.2% of those treated with fluconazole. Furthermore, oteseconazole proved noninferior to fluconazole in the resolution of symptoms at day 14 of the study.
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).
With a Dec. 20 PDUFA date bearing down on relugolix from Myovant Sciences GmbH, of Basel, Switzerland, freshly released and slightly downbeat secondary endpoint phase III data created a rift with management and analysts on one side and investors on the other.
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).
DUBLIN – Ipsen SA is on track for an NDA filing for palovarotene in fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease characterized by the gradual replacement of skeletal muscle and connective tissue with bone, following an interim analysis of phase III data which indicates that the drug may have a substantial effect on the disease process.
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