FDA News, New Drug Approvals, Biotech and Pharmaceutical Stock News
- FDA Approves Trudhesa (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine
- FDA Approves Invega Hafyera (paliperidone palmitate) for Twice-Yearly Treatment for Adults with Schizophrenia
- U.S. FDA Grants Brukinsa (zanubrutinib) Approval in Waldenström’s Macroglobulinemia
- UCB Announces Briviact (brivaracetam) Now FDA-Approved to Treat Partial-Onset Seizures in Pediatric Patients One Month of Age and Older
- Servier Announces FDA Approval of Tibsovo (ivosidenib tablets) in IDH1-Mutated Cholangiocarcinoma
- FDA Approves Skytrofa (lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Pediatric Growth Hormone Deficiency
- Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke Kit for the Treatment of Severe Hypoglycemia
- FDA Approves Korsuva (difelikefalin) Injection for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients
- FDA Approves Comirnaty (Pfizer-BioNTech COVID-19 Vaccine) to Prevent COVID-19 Individuals 16 Years and Older
- U.S. Food and Drug Administration Approves Opdivo (nivolumab) for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma
- FDA Approves Jardiance (empagliflozin) to Treat Adults Living with Heart Failure with Reduced Ejection Fraction
- GSK Receives FDA Accelerated Approval for Jemperli (dostarlimab-gxly) for Adult Patients with Mismatch Repair-Deficient (dMMR) Recurrent or Advanced Solid Tumors
- FDA Approves Lyumjev (insulin lispro-aabc injection) 100 units/mL for Use in Insulin Pumps
- FDA Approves Welireg (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors
- FDA Approves TicoVac (tick-borne encephalitis vaccine) to Prevent Tick-Borne Encephalitis (TBE)