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The European Commission ( EC ) has approved Bavencio ( Avelumab ) in combination with Axitinib ( Inlyta ) for the first-line treatment of adult patients with advanced renal cell carcinoma ( RCC ). ...


The European Commission has approved Xeomin ( IncobotulinumtoxinA ) for the symptomatic treatment of chronic sialorrhea due to neurological disorders in adult patients. Xeomin is the first and only n ...


The European Commission ( EC ) has approved the oral once-daily therapy Xospata ( Gilteritinib ) as a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia ...


The FDA ( U.S. Food and Drug Administration ) has approved Sunosi ( Solriamfetol ) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive ...


The FDA ( U.S. Food and Drug Administration ) has approved Reyvow ( Lasmiditan ) tablets for the acute treatment of migraine with or without aura ( a sensory phenomenon or visual disturbance ) in adul ...


The FDA ( U.S. Food and Drug Administration ) has approved Ofev ( Nintedanib ) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with syste ...


The FDA ( U.S. Food and Drug Administration ) has expanded the approval of Mavyret ( Glecaprevir and Pibrentasvir ) tablets for an eight-week duration for the treatment of adults and children ages 12 ...


The European Commission has granted marketing authorization in the European Union ( EU ) for the precision oncology treatment Vitrakvi ( Larotrectinib ). The drug is indicated for the treatment of a ...


The European Commission ( EC ) has granted marketing authorisation for Erleada ( Apalutamide ), a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastat ...


The FDA ( U.S. Food and Drug Administration ) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence ( OCE ). Project Orbis provides a framework for concurrent submissio ...


The European Commission ( EC ) has approved Empliciti ( Elotuzumab ) plus Pomalidomide and low-dose Dexamethasone ( EPd ) for the treatment of adult patients with relapsed and refractory multiple myel ...


The Food and Drug Administration ( FDA ) has approved Nubeqa ( Darolutamide ) for non-metastatic castration-resistant prostate cancer. Approval was based on ARAMIS, a multicenter, double-blind, pla ...


The European Commission has approved Tecentriq ( Atezolizumab ) plus chemotherapy ( Abraxane [ Paclitaxel protein-bound particles for injectable suspension ( albumin-bound ); nab-Paclitaxel ] ) for th ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Xpovio ( Selinexor ) in combination with Dexamethasone for adult patients with relapsed or refractory multiple myeloma ( RR ...


The FDA ( Food and Drug Administration ) has approved Inrebic ( Fedratinib ) for adults with intermediate-2 or high-risk primary or secondary ( post-polycythemia vera or post-essential thrombocythemia ...


The FDA ( U.S. Food and Drug Administration ) has approved Rinvoq ( Upadacitinib ), a 15 mg, once-daily oral Janus kinase ( JAK ) inhibitor, for the treatment of adults with moderately to severely act ...


The FDA ( U.S. Food and Drug Administration ) has approved Emgality ( Galcanezumab-gnlm; Galcanezumab ) solution for injection for the treatment of episodic cluster headache in adults. Cluster hea ...


The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Rozlytrek ( Entrectinib ), a treatment for adult and adolescent patients whose cancers have the specific genetic defec ...


The FDA ( U.S. Food and Drug Administration ) has granted approval to Turalio ( Pexidartinib ) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor ( TGCT ) asso ...


The European Commission has granted Marketing Authorisation for Dovato ( Dolutegravir / Lamivudine ) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at le ...


The FDA ( U.S. Food and Drug Administration ) has approved Dupixent ( Dupilumab ) for use with other medicines to treat chronic rhinosinusitis with nasal polyposis ( CRSwNP ) in adults whose disease i ...


The European Commission has approved Talzenna ( Talazoparib ), an oral poly (ADP-ribose) polymerase ( PARP ) inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer s ...


The European Commission ( EC ) has approved Lynparza ( Olaparib ) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer. The licensed indication is as a maintenanc ...


The European Commission ( EC ) has granted conditional marketing authorization for Lorviqua ( Lorlatinib, available in the U.S., Canada and Japan under the brand name Lorbrena ), as a monotherapy for ...


The European Commission has approved Dupixent ( Dupilumab ) for use in adults and adolescents 12 years and older as an addon maintenance treatment for severe asthma with type 2 inflammation characteri ...


The U.S. Food and Drug Administration ( FDA ) has approved Jakafi ( Ruxolitinib ) for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is the f ...


The FDA ( U.S. Food and Drug Administration ) has approved Piqray ( Alpelisib ) tablets, to be used in combination with the FDA-approved endocrine therapy Fulvestrant, to treat postmenopausal women, a ...


The US Food and Drug Administration ( FDA ) has approved Bavencio ( Avelumab ) in combination with Inlyta ( Axitinib ) for the first-line treatment of patients with advanced renal cell carcinoma ( RCC ...


The U.S. Food and Drug Administration ( FDA ) has approved Venclexta ( Venetoclax ) in combination with Obinutuzumab ( Gazyva ) for previously untreated patients with chronic lymphocytic leukemia ( CL ...


The U.S. Food and Drug Administration ( FDA ) has approved Cyramza ( Ramucirumab injection, 10 mg/mL solution ), as a single agent, for the treatment of patients with hepatocellular carcinoma ( HCC ) ...


The FDA ( U.S. Food and Drug Administration ) has approved Benlysta ( Belimumab ) intravenous ( IV ) infusion for treatment of children with systemic lupus erythematosus ( SLE ), a serious chronic dis ...


The European Commission ( EC ) has approved Skyrizi ( Risankizumab ) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. Skyrizi ( 150 m ...


The European Commission has granted marketing authorization for Zynquista ( Sotagliflozin ), at once-daily doses of 200 mg and 400 mg, for use as an adjunct to Insulin therapy to improve glycemic cont ...


The FDA ( U.S. Food and Drug Administration ) has approved Praluent ( Alirocumab ) to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with est ...


The FDA ( U.S. Food and Drug Administration ) has approved Dovato ( Dolutegravir and Lamivudine ), as a complete regimen for the treatment of human immunodeficiency virus type 1 ( HIV-1 ) infection in ...


The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Balversa ( Erdafitinib ), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a ...


The FDA ( U.S. Food and Drug Administration ) has approved Mayzent ( Siponimod ) tablets to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing- ...


The FDA ( U.S. Food and Drug Administration ) has extended the indication of Ibrance ( Palbociclib ) capsules in combination with specific endocrine therapies for hormone receptor-positive ( HR+ ), hu ...


The FDA ( U.S. Food and Drug Administration ) has approved Zulresso ( Brexanolone ) injection for intravenous ( IV ) use for the treatment of postpartum depression ( PPD ) in adult women. This is th ...


The European Commission ( EC ) has approved a new indication for Praluent ( Alirocumab ), to reduce cardiovascular ( CV ) risk in adults with established atherosclerotic CV disease ( ASCVD ) by loweri ...


The FDA ( U.S. Food and Drug Administration ) has approved Spravato ( Esketamine ) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried oth ...


The FDA ( U.S. Food and Drug Administration ) has approved Keytruda ( Pembrolizumab ), anti-PD-1 therapy, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) followi ...


The FDA ( U.S. Food and Drug Administration ) has granted approval for a new indication for Alimta ( Pemetrexed for injection ) in combination with Pembrolizumab ( Keytruda ) and Platinum chemotherapy ...


The FDA ( U.S. Food and Drug Administration ) has approved Cablivi ( Caplacizumab-yhdp ) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytop ...


The European Commission ( EC ) has approved Mylotarg ( Gemtuzumab ozogamicin ) in combination with Daunorubicin and Cytarabine for the treatment of patients age 15 years and above with previously untr ...


The U.S. Food and Drug Administration ( FDA ) has approved the 2-mg dose of Olumiant ( Baricitinib ), a once-daily oral medication for the treatment of adults with moderately-to-severely active rheuma ...


The Food and Drug Administration ( FDA ) has approved Lutathera ( Lutetium Lu 177 Dotatate ), a radiolabeled Somatostatin analog, for the treatment of Somatostatin receptor-positive gastroenteropancre ...


The Food and Drug Administration ( FDA ) has approved Hemlibra ( Emicizumab-kxwh; Emicizumab ) injection for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric ...


The U.S. Food and Drug Administration ( FDA ) has granted accelerated approval to Vitrakvi ( Larotrectinib ), a treatment for adult and pediatric patients whose cancers have a specific genetic feature ...


Menière's disease ( MD ) is an idiopathic pathological condition of the inner ear ( IE ) whose major symptoms are vertigo, fluctuating hearing loss, tinnitus, and fullness. These symptoms are most o ...