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                News & Events for Human Drugs

News & Events for Human Drugs

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          News & Events for Human Drugs
          Notable Approvals | DrugsNews & Events for Human Drugs Notable Approvals | Drugs
  
  	
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			Date
			Brand Name
			Active IngredientFDA approves new drug under special pathway for patients receiving hemodialysis
			11/15/2023
			Defencath
			taurolidine and heparinFDA approves first biosimilar to Actemra to treat adult and pediatric arthritis
			9/29/2023
			Tofidence
			tocilizumab-baviFDA approves multiple generics of ADHD and BED treatment
			8/28/2023
			Vyvanse
			lisdexamfetamine dimesylateFDA approves first treatment for CD55-deficient protein-losing enteropathy (CHAPLE disease)
			8/18/2023
			Veopoz
			pozelimab-bbfgFDA approves first treatment for Fibrodysplasia Ossificans Progressiva
			8/17/2023
			Sohonos
			palovaroteneFDA approves first treatment for molluscum contagiosum
			7/24/2023
			Ycanth
			cantharidinFDA approves first treatment for pediatric functional constipation
			6/12/2023
			Linzess
			linaclotideFDA approves treatment for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma
			5/19/2023
			Epkinkly
			epcoritamab-byspFDA approves first oral treatment for moderately to severely active Crohn’s disease
			5/18/2023
			Rinvoq
			upadacitinibFDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
			4/25/2023
			Qalsody
			tofersenFDA approves first treatment for activated phosphoinositide 3-kinase delta syndrome
			3/24/2023
			Joenja
			leniolisibFDA approves first treatment for Rett Syndrome
			3/13/2023
			Daybue
			trofinetideFDA approves first treatment for Friedreich’s ataxia
			2/28/2023
			Skyclarys
			omaveloxoloneFDA approves first enzyme replacement therapy for rare alpha-mannosidosis
			2/17/2023
			Lamzede
			velmanase alfaFDA approves drug combination treatment for adults with asthma
			1/10/2023
			Airsupra
			albuterol-budesonideFDA approves imaging drug to help identify lung cancer lesions
			12/16/2022
			Cytalux
			pafolacianineFDA approves first treatment for prurigo nodularis
			9/28/2022
			Dupixent
			dupilumabFDA approves treatment to improve kidney function in adults with hepatorenal syndrome
			9/14/2022
			Terlivaz
			terlipressinFDA approves topical treatment addressing repigmentation in vitiligo in patients aged 12 and older
			7/19/2022
			Opzelura
			ruxolitinibFDA approves treatment for chronic weight management in pediatric patients aged 12 years and older
			6/24/2022
			Qsymia
			phentermine and topiramateFDA approves treatment for weight management in patients with Bardet-Biedl Syndrome aged 6 or older
			6/16/2022
			Imcivree
			setmelanotideFDA Approves Oral Form for the treatment of adults with amyotrophic lateral sclerosis (ALS)
			5/12/2022
			Radicava ORS
			edaravoneFDA approves new drug to improve heart function in adults with rare heart condition
			4/29/2022
			Camzyos
			mavacamtenFDA approves drug for treatment of seizures associated with rare disease in patients two years of age and older
			3/18/2022
			Ztalmy
			ganaxoloneFDA approves drug for adults with rare form of bone marrow disorder
			2/28/2022
			Vonjo
			pacritinibFDA approves treatment for anemia in adults with rare inherited disorder
			2/17/2022
			Pyrukynd
			mitapivatFDA approves treatment for adults with rare type of anemia
			2/4/2022
			Enjaymo
			sutimlimab-jomeFDA approves add-on therapy to lower cholesterol among certain high-risk adults
			12/22/2021
			Leqvio
			inclisiranFDA approves drug to treat, help prevent types of blood clots in certain pediatric populations
			12/20/2021
			Xarelto
			rivaroxabanFDA approves Tezspire as maintenance treatment for severe asthma
			12/17/2021
			Tezspire
			tezepelumab-ekkoFDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years
			12/17/2021
			Oxbryta
			voxelotorFDA approves first drug to decrease urine protein in IgA nephropathy, a rare kidney disease
			12/15/2021
			Tarpeyo
			budesonideFDA approves naloxone injection to counteract opioid overdoses
			10/15/2021
			ZIMHI
			naloxone hydrochlorideFDA approves add-on drug for adults with rare form of blood vessel inflammation
			10/13/2021
			Tavneos
			avacopanFDA approves add-on drug for ages 10 & up with rare forms of high cholesterol
			9/24/2021
			Repatha
			evolocumabFDA approves new use of transplant drug based on real-world evidence
			7/16/2021
			Prograf
			tacrolimusFDA approves drug to reduce risk of serious kidney and heart complications in adults with chronic kidney disease associated with type 2 diabetes
			7/9/2021
			Kerendia
			finerenoneFDA approves therapy for pediatric patients with serious rare blood disease
			6/7/2021
			Ultomiris
			ravulizumab-cwvzFDA approves drug to treat smallpox
			6/4/2021
			Tembexa
			brincidofovirFDA approves second PSMA-targeted PET imaging drug for men with prostate cancer
			5/27/2021
			Pylarify
			piflufolastat F 18FDA approves new treatment for adults with serious rare blood disease
			5/14/2021
			Empaveli
			pegcetacoplanFDA approves add-on therapy for patients with genetic form of severely high cholesterol
			4/1/2021
			Praluent
			alirocumabFDA approves first treatment for disease that causes recurrent inflammation in sac surrounding heart
			3/18/2021
			Arcalyst
			rilonaceptFDA approves add-on therapy for patients with genetic form of severely high cholesterol
			2/11/2021
			Evkeeza
			evinacumab-dgnbFDA approves treatment for ebola virus
			12/21/2020
			Ebanga
			Ansuvimab-zyklFDA approves weight management drug for patients aged 12 and older
			12/4/2020
			Saxenda
			liraglutideFDA approves first treatment for weight management for people with certain rare genetic conditions
			11/27/2020
			Imcivree
			setmelanotideFDA’s approval of Veklury (remdesivir) for the treatment of COVID-19—the science of safety and effectiveness
			10/22/2020
			Veklury
			remdesivirFDA approves weekly therapy for adult growth hormone deficiency
			9/1/2020
			Sogroya
			somapacitanFDA approves new treatment for rare hereditary disease
			8/23/2018
			Takhzyro
			lanadelumab

                                                                                  Content current as of:
      11/15/2023
              
              
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		 DrugsNews & Events for Human Drugs

          
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