Pfizer and BioNTech’s updated COMIRNATY vaccine, targeting the LP.8.1 COVID-19 sublineage, gained FDA approval for use in seniors and high-risk individuals aged 5 to 64. The vaccine promises enhanced immune defense against current variants and is set for immediate distribution across the U.S.
The U.S. Food and Drug Administration (FDA) has broadened the approved use of Amgen’s Repatha (evolocumab) for adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C).
Novo Nordisk’s Wegovy has received FDA approval to treat MASH, a serious liver disease linked to obesity and diabetes. This new indication highlights Wegovy’s role in improving liver fibrosis and reversing liver damage alongside lifestyle changes.
The US FDA has granted priority review to GSK’s new drug application for gepotidacin, a potential new oral treatment for uncomplicated urogenital gonorrhea.
The U.S. FDA has declined to approve an expanded indication for Johnson & Johnson’s multiple myeloma therapy, Darzalex Faspro. The decision, delivered via a Complete Response Letter, was not based on the drug’s clinical efficacy but on unresolved issues at a third-party manufacturing facility.
AstraZeneca‘s supplemental biologics license application (sBLA) for Imfinzi (durvalumab) has been approved and given priority review in the U.S. FDAÂ for the treatment of patients with [Read More…]
Novo Nordisk reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a favorable opinion, suggesting that [Read More…]
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion under accelerated review, recommending lenacapavir, the company’s [Read More…]
The European Commission (EC) has granted a landmark approval for Johnson & Johnson’s DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma (SMM). This decision marks a significant shift in the treatment paradigm for this precursor to active multiple myeloma, moving away from the traditional “watch and wait” approach to proactive, early therapeutic intervention.
Genentech, a member of the Roche Group, announced Friday that the U.S. Food and Drug Administration (FDA) has rejected its application to expand the use of its cancer drug Columvi® (glofitamab-gxbm). The FDA issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA), effectively declining to approve Columvi in combination with chemotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
