Tradename: VARIVAX Proper Name: Varicella Virus Vaccine Live Indication: To include safety and immunogenicity data that supports the intramuscular route as an additional route of administration for VARIVAX, and associated…
Name: Technegas Active Ingredient: technetium Tc 99m carbon Indications: Technegas (technetium Tc 99m carbon) is a radioactive diagnostic agent for the evaluation of pulmonary embolism. Approval Date: 09/29/2023 Company: Cyclopharm…
Drug Name: Tofidence Active Ingredient: tocilizumab-baviIndications: Tofidence is an interleukin-6 (IL-6) receptor antagonist that targets specific inflammatory proteins to suppress the immune system. Tofidence is approved for rheumatoid arthritis in…
Drug Name: Pombiliti Active Ingredient: cipaglucosidase alfa-atga Indications: To treat late-onset Pompe disease Approval Date: 9/28/2023 Company: Amicus Therapeutics, Inc. More: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761204s000lbl.pdf
Drug Name: Exxua Active Ingredient: gepirone Indications: To treat major depressive disorder Approval Date: 9/22/2023 Company: Mission Pharmacal Company More: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021164s000lbl.pdf
Drug Name: Ojjaara Active Ingredient: momelotinib Indications: To treat intermediate or high-risk myelofibrosis in adults with anemia Approval Date: 9/15/2023 Company: GlaxoSmithKline More: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216873s000lbl.pdf
Beacon Biosignals is thrilled to announce the milestone achievement of FDA 510(k) Clearance for the Dreem 3S, an advanced wearable headband with integrated machine learning algorithms to capture electroencephalogram (EEG) data from…
Drug Name: Rivfloza Active Ingredient: nedosiran Indications: To lower urinary oxalate levels in patients 9 years and older with primary hyperoxaluria type 1 and relatively preserved kidney function Approval Date:…
Drug Name: Aphexda Active Ingredient: motixafortide Indications: To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with…
Tradename: ABRYSVO Proper Name: Respiratory Syncytial Virus Vaccine Indication: Indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory…