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).
The U.S. Food and Drug Administration (FDA) has given the green light to a new, prefilled syringe presentation of GSK’s highly effective shingles vaccine, Shingrix.
An application from GSK to increase the use of its very effective RSV vaccine, Arexvy, has been formally approved by the U.S. Food and Drug [Read More…]
The U.S. Food and Drug Administration (FDA) has officially approved an updated label for Eli Lilly’s groundbreaking Alzheimer’s drug, Kisunla (donanemab-azbt). This significant update introduces a new, more gradual dosing schedule specifically designed to enhance patient safety by reducing the risk of amyloid-related imaging abnormalities (ARIA), a critical side effect.
Novo Nordisk has applied to the European Medicines Agency (EMA) for a new, increased dosage of Wegovy® (semaglutide), a well-known medication for weight loss, of [Read More…]
