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AbbVie’s Rinvoq has gotten the thumbs up from the European Commission (EC) for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 and older who are candidates for systemic therapy, becoming the first Janus kinase (JAK) inhibitor approved for the condition in the EU for both adults and adolescents. Read More
Sesen Bio has withdrawn its EU marketing authorization application for Vysyneum (oportuzumab monatox-qqrs) — called Vicineum in the U.S. — a week after FDA regulators denied approval for the bladder cancer drug. Read More
The current standard of care consists of anti-seizure medications which target symptoms but do not target the underlying cause of the disease. Read More
Moderna said it has completed submitting data for its COVID-19 vaccine’s rolling biologics license application (BLA) and has requested an FDA Priority Review, which would require the FDA to make its decision within 60 days. Read More
Stealth BioTherapeutics is pursuing FDA approval for elamipretide, for treatment of Barth syndrome, a rare genetic disease, even though the FDA has said it needs to see data from an additional phase 3 study. Read More
The FDA has granted full approval to Pfizer’s/BioNTech’s mRNA COVID-19 vaccine in people age 16 years and older. The move is expected to ease worries among some as-yet-unvaccinated people, as well as inspiring more vaccine mandates from businesses and institutions. Read More