FDA OKs Cetirizine Injection (Quzyttir) for Acute Urticaria
Cetirizine hydrochloride (10 mg/mL) intravenous injection is for treatment of acute urticaria in adults and children 6 months of age or older. FDA Approvals
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FDA Clears First Transdermal Patch for Schizophrenia
The once-daily transdermal patch provides sustained concentrations of asenapine over 24 hours and is approved for patients with schizophrenia aged 18 and older. FDA Approvals
DA Allows Marketing of First Rapid Ebola Test
The FDA has allowed marketing of the first rapid diagnostic test (RDT) to identify Ebola virus antigens, or proteins, in certain body fluids from living and deceased individuals. FDA Approvals
FDA Allows Marketing of First Rapid Ebola Test
The FDA has allowed marketing of the first rapid diagnostic test (RDT) to identify Ebola virus antigens, or proteins, in certain body fluids from living and deceased individuals. FDA Approvals
FDA Approves Pfenex’s Osteoporosis Therapy
Reuters Health Information
FDA Approves Dexcom G6 Pro CGM for Use in Diabetes
Dexcom G6 Pro is a single-use, professional CGM that gathers real-time glucose data over 10 days and offers both a blinded and unblinded mode, enabling choice of whether patient sees the data or not. FDA Approvals
FDA OKs New Treatment Afamelanotide for Phototoxic Reactions
The FDA has approved afamelanotide (Scenesse, Clinuvel), offering relief of phototoxic reactions to sunlight for patients with erythropoietic protoporphyria. FDA Approvals
FDA Approves New Injection Brolucizumab (Beovu ) for Wet AMD
The US Food and Drug Administration approved brolucizumab (Beovu, Novartis) injection for wet age-related macular degeneration (AMD). FDA Approvals
Nobel Prize in Medicine Awarded to British-American Trio
Discoveries by two American and a British researcher regarding how cells sense and adapt to oxygen offer key insights for treating cancers and heart and lung diseases. Medscape Medical News
EU Panel: Don’t Use Estradiol Creams for Longer Than 4 Weeks
A European Medicines Agency committee warns against using certain estradiol creams for longer than a single period of 4 weeks to reduce the risk for adverse health effects. International Approvals
FDA OKs Asthma Drug Benralizumab (Fasenra) for At-Home Use
The Fasenra Pen is a prefilled, single-use autoinjector for use as adjunctive maintenance treatment for adults and for children aged 12 years or older who have severe eosinophilic asthma. FDA Approvals
FDA OKs Descovy, Second Drug for HIV PrEP
The combo of emtricitabine and tenofovir alafenamide is indicated to reduce the risk for HIV-1 infection from sex (excluding receptive vaginal sex) in at-risk adults and teens weighing at least 35 kg. FDA Approvals
FDA Clears Sacubitril/Valsartan for Children With Heart Failure
Sacubitril/valsartan is approved to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients 1 year and older. FDA Approvals
FDA Clears Architect Stat High-Sensitivity Troponin Test for MI
Abbott’s Architect Stat troponin-I assay can identify myocardial infarction several hours sooner than standard troponin tests and improve diagnosis in women, the company says. FDA Approvals
FDA OKs First Treatment for Rare Types of Vasculitis in Kids
The FDA has approved rituximab injection for granulomatosis with polyangiitis and microscopic polyangiitis in children aged 2 years or older. FDA Approvals
FDA OKs Canagliflozin to Curtail Diabetic Kidney Disease
Results of CREDENCE lead to FDA approval for canagliflozin to slow kidney disease progression and reduce the risk of heart failure hospitalization in adults with type 2 diabetes. FDA Approvals
FDA Approves Daratumumab Combo for New First-Line Use
The drug is now approved in combination with three other agents for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant. FDA Approvals
FDA Clears Novel ‘Recharge-Free’ Device for Chronic Pain
Abbott’s Proclaim XR platform utilizes the company’s low energy BurstDR stimulation waveform to provide effective pain relief without the hassle of recharging for up to 10 years. FDA Approvals
Second Generic Zantac Recall Due to Contamination Concerns
Apotex Corp has voluntarily recalled all pack sizes and formats of ranitidine tablets in the US on a ‘precautionary basis’ after a probable carcinogen was found in other generic Zantac products. Medscape Medical News
FDA Further Expands Approval of HCV Combo Drug Mavyret
Mavyret is the first 8-week treatment approved for all treatment-naive adult and certain pediatric patients with any hepatitis C virus genotype, both without cirrhosis and with compensated cirrhosis. FDA Approvals