FDA Grants Accelerated Approval to Dostarlimab for Advanced dMMR Endometrial Cancer
This indication is approved under accelerated approval based on tumor response rate and durability of response.
FDA OKs New Combined Oral Contraceptive
Nextstellis (drospirenone; estetrol) now is approved as a combined oral contraceptive for birth control.
AstraZeneca’s COVID-19 Vaccine Data Show 79% Efficacy Against Symptomatic Disease
AstraZeneca is preparing to submit its COVID-19 vaccine data to the FDA for emergency use authorization in the coming weeks.
FDA Grants Emergency Use Authorization to Third COVID-19 Vaccine
The FDA has granted emergency use authorization status for the first single-dose vaccine for COVID-19 in the United States.
FDA OKs Expanded Indication for Heart Failure Treatment
Novartis’ sacubitril/valsartan (Entresto) is now indicated for use in the treatment of chronic heart failure.
Belantamab mafodotin-blmf for Relapsed or Refractory Multiple Myeloma
Belantamab mafodotin-blmf is now indicated for adult patients with relapsed or refractory myeloma who have received at least 4 prior therapies.
FDA OKs Long-Acting Injectable Drug Regimen for HIV Treatment
Officials with the FDA have approved cabotegravir and rilpivirine, injectable formulation (Cabenuva; ViiV Healthcare) as a complete regimen for the treatment of HIV-1 infection in adults.
Remdesivir in the Treatment of COVID-19
On October 22, 2020, the FDA approved remdesivir (Veklury; Gilead) as the first treatment for coronavirus disease 2019 (COVID-19).
Leukemia, Bladder Cancer Drug Markets Expected to Soar
The market for acute lymphocytic leukemia and bladder cancer drug therapies is expected to soar over the next few years, thanks in part to new and innovative medications.
Top FDA Approvals of 2020
Here are some of the top-read FDA approvals covered by Drug Topics® from this year.
Leucadia Pharmaceuticals Launches Acetaminophen Injection
Acetaminophen injection, 1000 mg/100 mL, is an FDA-approved generic to Ofirmev.
Azacitidine Tablets for Acute Myeloid Leukemia
The FDA approved azacitidine tablets (Onureg; Celgene Corporation) on September 1, 2020
FDA OKs Omalizumab for Maintenance Treatment of Nasal Polyps
Omalizumab (Xolair; Genentech and Novartis) is the first biologic approved for the treatment of nasal polyps that targets and blocks immunoglobulin E.
Social Determinants of Health Analytics To Improve Patient Outcomes
Tim Suther, senior vice president of data solutions at Change Healthcare, discusses a new Social Determinants of Health Analytics resource.
FDA OKs First Treatment for Primary Hyperoxaluria Type 1
Lumasiran (Oxlumo; Alnylam Pharmaceuticals) is the first drug approved for the treatment of primary hyperoxaluria type 1, a rare genetic disorder.
SingleCare Announces New Home Delivery Service To Improve Access to Drugs
SingleCare, in partnership with GeniusRx, launched the delivery service with the goal of improving access to and affordability of popular medications.
Satralizumab-mwge for Neuromyelitis Optica Spectrum Disorder in Adults
An overview of the use of satralizumab-mwge (Enspryng; Genentech) in neuromyelitis optica spectrum disorder (NMOSD).
FDA Approves Short-Term Treatment for Dry Eye Disease
Loteprednol etabonate ophthalmic suspension (Eysuvis; Kala Pharmaceuticals) 0.25% is the first ocular corticosteroid indicated for dry eye disease.
FDA Approves Remdesivir for Treatment of COVID-19
Remdesivir (Veklury; Gilead) is the first and only fully FDA-approved treatment for COVID-19.
Clascoterone Cream 1% for the Treatment of Acne
Clascoterone cream 1% is a first-in-class topical acne treatment that targets the androgen receptors in the skin.
Oliceridine (Olinvyk) Offers New Treatment Option for Acute Pain Management in Hospitals and Controlled Clinical Settings
Oliceridine (Olinvyk; Trevena, Inc) is an intravenous opioid agonist indicated in adults for management of acute severe pain in a hospital or controlled clinical setting.
Sunovion Launches Sublingual Therapy for “Off” Episodes in Parkinson Disease
Apomorphine hydrochloride (Kynmobi; Sunovion) is a sublingual therapy for the acute intermittent treatment of off episodes in patients with Parkinson disease.
Fenfluramine for the Treatment of Seizures Associated With Dravet Syndrome
On June 25, 2020, fenfluramine (Fintepla) was approved for the treatment of seizures associated with Dravet syndrome in patients 2 years and older.
FDA OKs Preservative-Free OTC Eye Drops for Allergy Symptoms
The FDA has approved OTC ketotifen fumarate (Alaway Preservative Free; Bausch + Lomb and Eton Pharmaceuticals) ophthalmic solution, 0.035% antihistamine eye drops.
Teva Launches 2 New Digital Maintenance Inhalers
Teva’s 2 digital inhalers for patients with asthma provide insight into objective inhaler use data.
FDA Approves New Asthma Indication for Trelegy Ellipta
Fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta; GlaxoSmithKline) is indicated for the treatment of asthma in patients aged 18 years and older.
FDA OKs Tramadol Hydrochloride Oral Liquid for Pain Management
Tramadol hydrochloride (Qdolo; Athena Bioscience) oral solution is indicated for use when pain is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
FDA OKs Azacitidine Tablets for Acute Myeloid Leukemia
Oral azacitidine (Onureg; Celgene) is approved for patients in first remission with acute myeloid leukeimia.
Coronavirus News Roundup: FDA Issues EUA for Rapid Antigen Test, ASHP Releases COVID-19 Vaccine Guidelines
Here's the coronavirus-related news from this week that you should know.
FDA Issues Emergency Use Authorization to New 15-Minute COVID-19 Antigen Test
Abbott’s BinaxNOW COVID-19 Ag Card rapid test produces results in 15 minutes.
