Drugs.com - New Drug Approvals New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
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FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes
on January 23, 2023 at 9:01 pm
MARLBOROUGH, Mass.--(BUSINESS WIRE) January 23, 2023 --TheracosBio today announced that the U.S. Food and Drug Administration (FDA) has approved Brenzavvy (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. Brenzavvy is...
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Brukinsa (zanubrutinib) Approved in the U.S. for Chronic Lymphocytic Leukemia
on January 19, 2023 at 10:01 pm
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. -- January 19, 2023 --(BUSINESS WIRE)-- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has...
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Seagen Announces FDA Accelerated Approval of Tukysa (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
on January 19, 2023 at 8:01 pm
BOTHELL, Wash.--(BUSINESS WIRE) January 19, 2023 -- Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients...
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FDA Approves Adacel for Immunization During Pregnancy to Help Protect Young Infants Against Pertussis
on January 17, 2023 at 9:01 pm
Expanded indication will help protect infants in the first months of life when their immune systems are still developing Bridgewater, NJ, January 17th, 2023 -- The U.S. Food and Drug Administration (FDA) has approved Adacel (Tetanus...
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FDA Approves Rykindo (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia and Bipolar 1 Disorder
on January 15, 2023 at 9:01 pm
PRINCETON, N.J., Jan. 15, 2023 /PRNewswire/ -- Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications, today announced that the U.S. Food and Drug...
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Novo Nordisk Announces FDA Approval of Label Update for Rybelsus (semaglutide) Allowing Use as a First-Line Option for Adults with Type 2 Diabetes
on January 12, 2023 at 9:01 pm
People living with type 2 diabetes can now take Rybelsus®, the first and only oral glucagon-like peptide-1 (GLP-1) analog, along with diet and exercise, as initial therapy to help lower their A1C1,2 Since its approval, Rybelsus® has been...
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FDA Approves Airsupra (albuterol/budesonide) Metered-Dose Inhaler to Reduce the Risk of Asthma Exacerbations
on January 11, 2023 at 12:01 am
January 11, 2023 -- Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years...
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FDA Approves Leqembi (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease
on January 6, 2023 at 7:01 pm
Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with Leqembi™ Treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia...
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FDA Approves NexoBrid (anacaulase-bcdb) for the Treatment of Severe Thermal Burns in Adults
on December 29, 2022 at 6:12 pm
YAVNE, Israel, Dec. 29, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today...
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FDA Approves Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis
on December 28, 2022 at 2:12 am
NEW YORK, Dec. 28, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the U.S. Food and Drug Administration (FDA) has approved Briumvi™ (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis...
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FDA Approves Xenoview (xenon Xe 129 hyperpolarized) for use with MRI for the Evaluation of Lung Ventilation
on December 28, 2022 at 2:12 am
Durham, N.C., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Polarean Imaging plc (AIM: POLX), the medical imaging technology company, announces that the U.S. Food and Drug Administration (“FDA”) has granted approval for its drug device combination...
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FDA Approves Olpruva (sodium phenylbutyrate) for Patients with Urea Cycle Disorders
on December 27, 2022 at 2:12 am
NEWTON, Mass. and GENEVA, Dec. 27, 2022 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. and its collaboration partner, RELIEF THERAPEUTICS Holding SA (“Relief”), today announced that the U.S. Food and Drug Administration (FDA) has approved...
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FDA Approves Once-Weekly Wegovy injection for the Treatment of Obesity in Teens Aged 12 Years and Older
on December 23, 2022 at 5:12 pm
New indication based on clinical trial that demonstrated a 16.1% reduction in body mass index (BMI) in teens with obesity treated with Wegovy® (semaglutide) injection 2.4 mg compared to placebo (0.6% increase in BMI) 1 Approval represents a...
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FDA Approves Lunsumio (mosunetuzumab-axgb) for the Treatment of Relapsed or Refractory Follicular Lymphoma
on December 22, 2022 at 4:12 am
With Lunsumio, people with heavily pretreated follicular lymphoma (FL) may experience remission with a chemotherapy-free, fixed-duration treatment that can be accessed in an outpatient setting Results from the pivotal Phase II GO29781 study...
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FDA Approves Sunlenca (lenacapavir) Twice-Yearly Treatment for People Living With Multi-Drug Resistant HIV
on December 22, 2022 at 3:12 am
Sunlenca is the First and Only Approved Capsid Inhibitor-Based HIV Treatment Option New Drug Application Approval Based on High Rates of Sustained Virologic Suppression in the CAPELLA Trial FOSTER CITY, Calif.--(BUSINESS WIRE) December...
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FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults
on December 21, 2022 at 11:12 pm
South San Francisco, CA -- December 21, 2022 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab)...
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Radius Health’s Tymlos (abaloparatide) Receives U.S. FDA Approval as a Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture
on December 20, 2022 at 11:12 pm
Cambridge, Mass., December 20, 2022 – Radius Health, Inc. (“Radius” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved Tymlos® (abaloparatide), a parathyroid hormone...
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Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for Pemfexy in Combination with Pembrolizumab and Platinum Chemotherapy
on December 19, 2022 at 10:12 pm
Additional indication is for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations Represents the fifth indication for Pemfexy, a ready-to-use liquid with a...
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FDA Approves Adstiladrin (nadofaragene firadenovec-vncg) for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
on December 16, 2022 at 8:12 pm
Ferring’s novel adenovirus vector-based gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) is the first gene therapy approved for bladder cancer Efficacy and safety of Adstiladrin supported by Phase 3 results demonstrating that...
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U.S. FDA Approves Vraylar (cariprazine) as an Adjunctive Treatment for Major Depressive Disorder
on December 16, 2022 at 2:12 am
Approval marks fourth indication for Vraylar, backed by proven efficacy and well-established tolerability as an adjunctive treatment for major depressive disorder (MDD) with an antidepressant therapy (ADT), showing improvement in symptoms when...
