The U.S. Food and Drug Administration approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
The U.S. Food and Drug Administration will weigh the benefits of authorizing a round of boosters of either the Pfizer/BioNTech or Moderna COVID-19 vaccine to a broader population in the fall, a top official said on March 29.
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth shot of the Pfizer-BioNTech and Moderna COVID-19 vaccines for everyone 50 years of age and older.
The U.S. Food and Drug Administration approved a 2 mg dose of Novo Nordisk’s Ozempic (semaglutide) injection, a once-weekly glucagon-like peptide-1 (GLP-1) analog indicated along with diet and exercise to improve blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.
UCB’s Fintepla (fenfluramine) oral solution CIV was approved in the United States for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older. Additionally, the FDA granted pediatric exclusivity for the product.
The U.S. health regulator said on March 25 the current authorized dose of GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody therapy is unlikely to be effective against the Omicron BA.2 variant.
Shares of MEI Pharma Inc. plunged more than 60% in trading on March 25 after the company announced that additional clinical research will be needed in order for the its phosphatidylinositol-3-kinase (PI3K) inhibitor zandelisib to be considered for regulatory approval.
The European Medicines Agency on March 25 recommended the use of Johnson & Johnson and partner Legend Biotech Corp.’s CAR-T therapy Carvykti to treat multiple myeloma, nearly a month after the treatment was cleared in the United States.
Pfizer announced March 24 that the company received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the vaccine candidate PF-06928316 (RSVpreF), intended to prevent infections caused by a respiratory syncytial virus (RSV).
The U.S. Food and Drug Administration rejected Eli Lilly’s Biologics License Application, issuing a Complete Response Letter for the company’s PD-1 checkpoint inhibitor sintilimab.
