Tag Archive for: regulatory approval

The therapy Tecvayli is a bispecific antibody, which is engineered to redirect body’s immune system to recognize and kill cancer cells. It is the first drug of its class to be approved for multiple myeloma.

The approval marks the end of a long path to the market for the therapy, Furoscix, after the regulator rejected it twice.

The FDA has approved Regeneron and Sanofi’s Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis, making it the first drug approved for this indication.

The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.

Pfizer Inc. and its German partner BioNTech on Monday sought the U.S. Food and Drug Administration’s authorization for an Omicron-tailored COVID-19 vaccine booster for children aged 5 through 11 years.

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu has been approved by the U.S. Food and Drug Administration as the first HER2-directed medicine for patients with HER2-mutant metastatic NSCLC, a particularly lethal form of the disease.

Booster campaigns using upgraded shots specifically targeting the Omicron variant are expected to increase demand in autumn. Pending regulatory approval, BioNTech said, both of its adapted vaccines would be available in time for the campaigns.

The digital health company touts its approval for the first and only machine learning algorithm to assist healthcare professionals in identifying structural heart murmurs using a smart stethoscope.

The agency will expedite its review of Eisai Co Ltd’s (4523.T) and Biogen Inc’s (BIIB.O) experimental Alzheimer’s drug lecanemab, with a decision due by Jan 6, 2023, the companies said on Tuesday.