FDA recently approved Amgen’s Repatha to treat pediatric patients ten and older with autosomal dominant disease, heterozygous familial hypercholesterolemia (HeFH), to reduce low-density...
FDA recently approved Samsung Bioepis and Biogen’s Byooviz as the first biosimilar to Lucentis to treat several eye diseases and conditions.
Byooviz is approved to treat neovascular (wet)...
FDA recently approved Johnson & Johnson’s long-acting atypical antipsychotic, Invega Hafyera, the first and only twice yearly injectable to treat schizophrenia in adults.
Providers...
FDA recently approved the MicroTransponder Vivistim Paired VNS System (Vivistim System) to treat moderate to severe upper extremity motor deficits associated with chronic ischemic...
FDA recently granted accelerated approval to GSK’s PD-1 blocking antibody drug, Jemperli, for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid...
FDA recently approved Abbott’s device to treat individuals with atrial fibrillation (AFib) at risk of ischemic stroke.
The Amplatzer Amulet Left Atrial Appendage Occluder immediately closes the...
FDA recently approved a new indication for chronic disease treatment, Xywav, intended for adults with idiopathic hypersomnia (IH).
The oral solution is already approved to treat cataplexy...
The novel FDA drug approval process allows researchers to uncover the appropriate dosage for both children and adults, determine the best route of administration, and test for any drug interactions....
FDA recently approved GSK’s Nucala, a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The new indication for...
FDA recently approved Mylan’s interchangeable biosimilar insulin product, Semglee, to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with...
FDA recently approved Merck’s anti-PD-1 therapy, Keytruda, for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with...
FDA recently approved the combination of Merck’s monoclonal antibody, Keytruda, and Eisai’s tyrosine kinase inhibitor, Lenvima, for the treatment of patients with advanced endometrial...
FDA recently approved Sanofi’s Fexinidazole, the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness.
The agency approved Fexinidazole for...
Merck recently announced that FDA approved an expanded label for its anti-PD-1 therapy, Keytruda, as a monotherapy for patients with locally advanced cutaneous squamous cell carcinoma (cSCC).
The...
FDA recently approved Jazz Pharmaceutical’s Rylaze as a component of a chemotherapy regimen to treat the most common childhood cancer
Specifically, Rylaze was approved to treat lymphoblastic...
FDA recently approved Boehringer Ingelheim Pharmaceuticals Pradaxa, the first oral blood thinning medication for children three months to less than 12 years old with venous thromboembolism.
Pradaxa...
FDA recently approved Novo Nordisk’s Wegovy obesity drug for chronic weight management in overweight adults with at least one weigh-related condition, including high blood pressure, type 2...
Three experts have resigned from FDA’s advisory committee following the agency’s approval of Biogen’s Alzheimer’s drug, aducanumab, according to multiple reports.
FDA approved...
FDA has approved Biogen’s drug for Alzheimer’s disease, Aduhelm (aducanumab), despite ongoing debate over the drug’s efficacy.
Aducanumab is a monoclonal antibody selected from...
