Phase 3
Ipsen said that Onivyde did not show greater benefit than topotecan used in patients with SCLC who have progressed on or after platinum-based first-line therapy treatment.
The FDA granted Priority Review for omidubicel with a target action date of January 30, 2023. Omidubicel is a first-in-class, advanced NAM (nicotinamide)-enabled stem cell therapy.
The BLA is for the use of the drug N-803 with BCG to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma with or without Ta or T1 disease.
Bristol Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) as an adjuvant treatment for localized renal cell carcinoma (RCC) failed to hit the primary endpoint.
The end of July is busy for the FDA, with Coherus, Sanofi, Acadia, Myovant and Pfizer having PDUFA dates filling the calendar. Here’s a look.
InMed updated its INM-755 for patients with epidermolysis bullosa, Seagen and Astellas announced positive topline results for Padcev with Merck’s Keytruda, and more.
The DESTINY-Breast04 trial introduces a new option for breast cancer diagnosis – HER2-low. The trial data received a standing ovation from thousands of oncologists at this year’s ASCO meeting.
On Wednesday, Swiss women’s health company ObsEva announced that it is dropping linzagolix, its leading candidate for uterine fibroids.
Ionis announced that the FDA has accepted its NDA for tofersen for SOD1-ALS. The application has been given the priority review designation and an action date of January 25, 2023.
Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted
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