Clinical research
Although no new safety concerns were observed, Merck’s Keytruda did not demonstrate significant improvements based on the pre-specified statistical plan.
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 has placed a clinical hold on Beam Therapeutics’ leukemia/lymphoma therapy and has lifted the hold on Celyad’s CAR-T candidate for colorectal cancer.
According to two recent studies, 10 to 30% of people with COVID-19 reported at least one persistent symptom up to six months after infection, which qualifies as Long COVID.
The exact implications of the paxalisib disappointment are still unclear, though it is highly likely that the candidate will be dropped from the GBM AGILE umbrella trial.
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 decision comes after the FDA put NUV-422, its candidate for high-grade gliomas, on a partial clinical hold, citing safety concerns.
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.
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