FDA News
The FDA has given the MEK inhibitor mirdametinib (Gomekli; SpringWorks) approval for the treatment of adult and pediatric patients aged ≥2 years with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PNs) not amenable to complete resection.1 With the approval, SpringWorks was granted a rare pediatric disease Priority Review Voucher by the FDA. Read More ›
Officials with Bavarian Nordic A/S have announced that the FDA has approved their recombinant chikungunya vaccine (Vimkunya) for injection, the first virus-like particle single-dose chikungunya vaccine in the United States for persons aged ≥12 years. Read More ›
Officials with AbbVie have announced that the FDA has approved aztreonam and avibactam (Emblaveo; AbbVie), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. Read More ›
In a first since the 1960s, methylenedioxymethamphetamine (MDMA)-assisted therapy for posttraumatic stress disorder (PTSD) and alcohol use disorder among veterans will be the subject of a study being launched by Veterans Affairs (VA). Read More ›
Fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo) has been approved by FDA officials for use in patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, who have progressed on one or more endocrine therapies in the metastatic setting. Read More ›
On January 17, 2025, the FDA approved datopotamab deruxtecan-dlnk (Datroway; Daiichi Sankyo) for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. Read More ›
The FDA has approved sotorasib (Lumakras; Amgen) with panitumumab (Vectibix; Amgen) for adult patients with KRAS G12C–mutated metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Read More ›
Acalabrutinib (Calquence; AstraZeneca) with bendamustine and rituximab has been greenlit for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem-cell transplantation (HSCT). Officials with the FDA also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL. Read More ›
Officials with the FDA have approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; Bristol Myers Squibb) for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of combination therapy. Read More ›
Ensartinib (Ensacove; Xcovery Holdings, Inc) has been approved for use in treating adult patients with ALK-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor. Read More ›