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.
- FDA Approves Omlonti (omidenepag isopropyl ophthalmic solution) for Reduction of Elevated Intraocular Pressure in Primary Open-Angle Glaucoma or Ocular Hypertensionon September 26, 2022 at 9:09 pm
EMERYVILLE, Calif. & UBE, Japan--(BUSINESS WIRE) September 26, 2022 --Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE) today announced that the U.S. Food and Drug Administration (FDA) has...
- FDA Approves Pedmark (sodium thiosulfate injection) to Reduce Risk of Ototoxicity Associated with Cisplatinon September 21, 2022 at 9:09 pm
Pedmark is the First and Only FDA-Approved Therapy Indicated to Reduce the Risk of Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic Solid Tumors RESEARCH TRIANGLE PARK, N.C., Sept. 21, 2022 (GLOBE...
- FDA Approves Skysona (elivaldogene autotemcel) Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)on September 18, 2022 at 10:09 pm
Skysona is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys with this devastating and fatal neurodegenerative disease SOMERVILLE, Mass.--(BUSINESS WIRE)--Sep. 16, 2022-- bluebird bio, Inc. (Nasdaq:...
- FDA Approves Aponvie (aprepitant) for the Prevention of Postoperative Nausea and Vomiting (PONV)on September 16, 2022 at 1:09 am
Aponvie is the first and only intravenous (IV) formulation of a substance P/neurokinin-1 (NK1) receptor antagonist indicated for PONV Delivered via a single 30-second IV injection, Aponvie has demonstrated rapid achievement of therapeutic drug...
- FDA Approves Terlivaz (terlipressin) for the Treatment of Hepatorenal Syndrome (HRS)on September 14, 2022 at 3:09 am
DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz (terlipressin) for injection. Terlivaz is...
- FDA Approves Rolvedon (eflapegrastim-xnst) Injection to Decrease the Incidence of Chemotherapy-Induced Neutropeniaon September 9, 2022 at 10:09 pm
First novel Long-Acting GCSF (LA-GCSF) product approved in over 20 years Rolvedon™ developed using proprietary LAPSCOVERY™ technology with a differentiated molecular structure and proven safety and efficacy profile Commercial team...
- FDA Approves Sotyktu (deucravacitinib) for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasison September 9, 2022 at 1:09 am
Bristol Myers Squibb’s Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the first innovation in oral treatment for moderate-to-severe plaque...
- FDA Approves Daxxify (daxibotulinumtoxinA-lanm) for Temporary Improvement of Moderate to Severe Glabellar Lines (Frown Lines)on September 8, 2022 at 2:09 am
NASHVILLE, Tenn.--(BUSINESS WIRE)--Sep. 8, 2022-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug...
- FDA Approves Stimufend (pegfilgrastim-fpgk), a Biosimilar to Neulastaon September 6, 2022 at 8:09 pm
September 6, 2022 -- Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced today that the United States (U.S.) Food and Drug...
- Imfinzi Plus Chemotherapy Approved in the US as the First Immunotherapy Regimen for Patients with Advanced Biliary Tract Canceron September 5, 2022 at 12:09 am
Approval based on TOPAZ-1 Phase III trial results, which showed Imfinzi combination reduced risk of death by 20% vs. chemotherapy alone September 05, 2022 -- AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for the treatment...
- FDA Approves Spevigo (spesolimab-sbzo) for Generalized Pustular Psoriasis (GPP) Flares in Adultson September 3, 2022 at 4:09 am
More than half of patients treated with Spevigo (spesolimab-sbzo) injection, for intravenous use showed no visible pustules one week after receiving treatment Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36)...
- FDA Approves Konvomep (omeprazole and sodium bicarbonate for oral suspension) for Gastric Ulcer and Reduction of Risk of Gastrointestinal Bleeding in Critically Ill Patientson September 3, 2022 at 2:09 am
WOBURN, Mass. (September 2, 2022) – Azurity Pharmaceuticals, Inc., a pharmaceutical company focused on developing innovative dose-forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food...
- Vertex Announces U.S. FDA Approval for Orkambi (lumacaftor/ivacaftor) in Children With Cystic Fibrosis Ages 12 to <24 monthson September 2, 2022 at 9:09 pm
With this approval, approximately 300 children with two copies of the F508del mutation will have a medicine to treat the underlying cause of their disease for the first time BOSTON--(BUSINESS WIRE)--Sep. 2, 2022-- Vertex Pharmaceuticals...
- FDA Approves Xenpozyme (olipudase alfa-rpcp) for Non-CNS Manifestations of Acid Sphingomyelinase Deficiency (ASMD)on August 31, 2022 at 3:08 am
Paris, August 31, 2022 -- The U.S. Food and Drug Administration (FDA) has approved Xenpozyme (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and...
- Incyte Announces FDA Approval of Pemazyre (pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangementon August 26, 2022 at 4:08 am
This marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2)...
- U.S. FDA Approves Imbruvica (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Diseaseon August 24, 2022 at 11:08 pm
August 24, 2022 (HORSHAM, PA) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Imbruvica® (ibrutinib) for the treatment of pediatric patients one...
- FDA Approves Auvelity (dextromethorphan and bupropion) for the Treatment of Major Depressive Disorder in Adultson August 20, 2022 at 2:08 am
Auvelity is the first and only rapid-acting oral treatment approved with labeling of statistically significant improvement in depressive symptoms compared to placebo starting at one week11-4 Auvelity uses the first new oral mechanism of action...
- FDA Approves Extension of Mirena (levonorgestrel-releasing intrauterine system) Intrauterine Device (IUD) for up to Eight Years of Pregnancy Preventionon August 18, 2022 at 1:08 am
WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer, a leader in women's healthcare, announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) that extends the duration of use for its market leading...
- FDA Approves Zynteglo (betibeglogene autotemcel) Gene Therapy for People with Beta-Thalassemia Who Require Regular Red Blood Cell Transfusionson August 17, 2022 at 9:08 pm
SOMERVILLE, Mass.--(BUSINESS WIRE)--Aug. 17, 2022-- bluebird bio, Inc. (Nasdaq: BLUE) today announced the U.S. Food and Drug Administration (FDA) has approved Zynteglo (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy...
- Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration Humira® Biosimilar Hadlima™ (adalimumab-bwwd)on August 17, 2022 at 4:08 am
INCHEON, Korea and Jersey City, N.J., United States – August 17, 2022 – Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free,...