U.S. Food and Drug Administration– tag –
-
FDA Accepts BioMarin’s sNDA for Full Approval of VOXZOGO® (vosoritide) in Children with Achondroplasia; PDUFA Date Set for February 28, 2027
BioMarin USA Overview The FDA has accepted BioMarin's supplemental New Drug Application (sNDA) seeking full approval for VOXZOGO® (vosoritide) in children with achondroplasia, setting a PDUFA target action date of February 28, 2027. This... -
FDA Accepts Shionogi’s sNDA for Fetroja® (cefiderocol) in Pediatric Patients with Serious Gram-Negative Infections
Shionogi Japan Overview The FDA has accepted Shionogi's supplemental New Drug Application (sNDA) for Fetroja® (cefiderocol) to treat serious infections caused by susceptible Gram-negative bacteria in pediatric patients. This submission a... -
2026 GLP-1 Agonist Pipeline Highlights Oral Orforglipron Approval and Retatrutide’s >28% Weight Reduction
Drug Discovery News USA Overview The 2026 GLP-1 agonist clinical pipeline is focusing on enhanced weight loss efficacy through novel mechanisms. Notably, Eli Lilly's oral small-molecule GLP-1 receptor agonist, orforglipron, received FDA ... -
First AI-Designed Drug Poised for FDA Approval by 2026-2027: Insilico Medicine’s IPF Candidate Leads
Oncodaily USA Overview The first AI-designed drug is increasingly likely to gain FDA approval between 2026 and 2027, with Insilico Medicine's rentosertib for idiopathic pulmonary fibrosis (IPF) identified as the leading candidate. Eli Li... -
FDA Approves Oral Carbapenem for cUTI and Combination Therapy for PTEN-Deficient Prostate Cancer in June 2026
Urology Times USA Overview In June 2026, the U.S. FDA announced multiple key approvals in urology, including the oral carbapenem antibiotic tebipenem pivoxil (Utebzi) for adult complex urinary tract infections (cUTI). Additionally, a com... -
FDA Grants Fast Track Designation to Multiple Oncology Drugs in May & June 2026, Including ADC for Metastatic Neuroendocrine Tumors
Oncology News Central USA Overview In May and June 2026, the U.S. FDA granted Fast Track designation to several novel oncology therapies, accelerating their development for serious conditions. Noteworthy designations include Zai Lab Limi... -
FDA Approves 22 Novel Drugs in First Half of 2026, Signaling Major Progress in Rare Disease Treatments
HCPLive USA Overview In the first half of 2026, the U.S. FDA approved a remarkable 22 novel drugs, driving significant advancements across diverse therapeutic areas including oncology, rare diseases, and ultra-rare conditions. Notable ap... -
FDA Approves Multiple Novel Oncology Drugs in June 2026, Including ADC for Breast Cancer and Combination for Prostate Cancer
Targeted Oncology USA Overview In June 2026, the U.S. FDA granted several new drug approvals and expanded indications in oncology, notably for Gilead Sciences' antibody-drug conjugate (ADC), sacituzumab govitecan-hziy (Trodelvy), in two ... -
GLP-1 Receptor Agonists Expand Therapeutic Scope to MASH: Novo Nordisk’s Wegovy First FDA-Approved for MASH, Eli Lilly’s Oral Foundayo Launched
Drug Discovery Trends USA Overview The therapeutic scope of GLP-1 receptor agonists has expanded beyond diabetes and obesity to include cardiovascular risk, obstructive sleep apnea, chronic kidney disease, and by 2025, MASH (Metabolic Dy... -
FDA Approves, Clears Trials for Autism-Related Symptom Treatments: DeFloria’s AJA001 Oral Liquid Enters Phase 2, Generic Leucovorin Approved
Barchart.com (via DelveInsight) USA Overview The FDA has authorized Phase II clinical trials for DeFloria's AJA001 oral liquid, a plant-derived drug candidate for autism spectrum disorder (ASD)-related symptoms. Additionally, in March 20...
