Posts

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.

Siga Technologies has won a new contract for its oral antiviral drug, Tpoxx, worth up to $10.7 million from the U.S. Department of Defense as the country stocks up on the treatment amid a monkeypox outbreak.

The U.S. Food and Drug Administration said on Tuesday it will now review only a small number of emergency use authorization requests for COVID tests that are likely to have a significant benefit to public health, including fulfilling an unmet need.

The agency put the partial hold after a serious adverse event was seen in a patient during the study.

The agency had earlier said Moderna requested authorization for additional batches in light of the current supply issues. It did not provide details on the number of doses cleared.

In an 8-4 vote, the FDA’s Oncologic Drugs Advisory Committee Roster voted against the benefit-risk profile of Secura Bio’s P13K inhibitor Copiktra (duvelisib).

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.

The company stated that it would start fresh late-stage studies of its HIV treatment, islatravir, months after the U.S. Food and Drug Administration put the trials on hold, citing safety concerns.

The agencies announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases.