Food and Drug Administration (FDA)
NEWS
The FDA has greenlit Merck and Ridgeback’s molnupiravir under EUA to treat mild to moderate COVID-19 infections in adults at high risk of progression to severe disease.
Studies found that AstraZeneca’s EVUSHELD was still effective against the Omicron variant. EVUSHELD is a long-acting antibody combination made up of tixagevimab and cilgavimab.
Janssen Pharmaceutical says goodbye to San Francisco’s Theravance Biopharma after a disappointing performance from a drug the two companies were developing together.
The latest approvals mark the first time a biologic has been approved for ERA. Cosentyx is also the only biologic approved in the United States for both ERA and PsA in pediatric patients.
The FDA has approved Novartis’ new drug for lowering bad cholesterol. Leqvio is the first and only siRNA treatment that can reduce low-density lipoprotein cholesterol.
The U.S. Food and Drug Administration granted Emergency Use Authorization to Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) for high-risk adults and pediatric patients 12 years and older to treat COVID-19.
Takeda hoped that its experimental therapy could become the first FDA-approved treatment for EoE. However, the FDA wants the company to initiate another clinical study with TAK-721.
The new Phase III study will include an enhanced version of the Viaskin Peanut patch, approximately 50% larger than the patch initially rejected by the FDA.
Novartis believes Gyroscope’s investigational Phase II gene therapy for geographic atrophy has the potential to become the first therapy that demonstrates sustained efficacy for GA patients.
JOBS
IN THE PRESS