Sponsor	Brand Generic Name	Indication	Approval Date
MediWound	NexoBrid (anacaulase-bcdb)	Removal of eschar in adults with deep partial- or full-thickness thermal burns	12/29/2022
Genentech (Roche)	Lunsumio (mosunetuzumab-axgb)	Treatment of adults with relapsed or refractory folicular lymphoma after two or more lines of systemic therapy	12/22/2022
Mirati Therapeutics	Krazati (adagrasib)	Treatment of adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy	12/12/2022
Forma Therapeutics and Rigel	Rezlidhia (olutasidenib)	Treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA approved test	12/1/2022
ImmunoGen	Elahere (mirvetuximab soravtansine-gynx)	Treatment of adults with FRα positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens, selected based on an FDA-approved test	11/14/2022
Johnson & Johnson (Janssen)	Tecvayli (teclistamab-cqyv)	Treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody	10/21/2022
AstraZeneca	Imjudo (tremelimumab-actl)	Treatment of adults with unresectable hepatocellular carcinoma	10/21/2022
Taiho Oncology	Lytgobi (futibatinib)	Treatment of adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements	9/30/2022
Amylyx Pharmaceuticals	Relyvrio (sodium phenlybutyrate and taurursodiol)	Oral treatment of amyotrophic lateral sclerosis in adults	9/29/2022
Mallinckrodt	Terlivaz (terlipressin)	Improvement in kidney function in adults with hepatorenal syndrome with rapid reduction kidney function	9/14/2022
Boehringer Ingelheim	Spevigo (spesolimab-sbzo)	Treatment of generalized pustular psoriasis flares in adults	9/1/2022
Sanofi	Xenpozyme (olipudase alfa-rpcp)	Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency in adult and pediatric patients	8/31/2022
Alnylam	Amvuttra (vutrisiran)	Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults	6/13/2022
Bristol Myers Squibb (Myokardia)	Camzyos (mavacamten)	Treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms	4/28/2022
Bristol Myers Squibb	Opdualag (relatlimab-rmbw and nivolumab)	Treatment of adult and pediatric patients 12 years of age or older with unresectable metastatic melanoma	3/18/2022
Marinus	Ztalmy (ganaxolone)	Treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder in patients 2 years of age and older	3/18/2022
CTI Biopharma	Vonjo (pacritinib)	Treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a baseline platelet count below 50 x 109/L	2/28/2022
Agios Pharmaceuticals	Pyrukynd (mitapivat)	Treatment of hemolytic anemia in adults with pyruvate kinase deficiency	2/17/2022
Bioverativ (Sanofi)	Enjaymo (sutimlimab-jome)	To decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease	2/2/2022
Immunocore	Kimmtrak (tebentafusp-tebn)	Treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma	1/25/2022
Ferring (Rebiotix)	Rebyota (fecal microbiota, live-jslm)	To prevent recurrence of Clostridioides difficile infection in adults after completion of antibiotic treatment for recurrent CDI	11/30/2022
CSL Behring	Hemgenix (etranacogene dezaparvovec-drlb)	Treatment of adults with hemophilia B who currently use Factor IX prophylaxis, or who have current or historical life-threatening hemorrhage or repeated, serious spontaneous bleeding episodes	11/22/2022
bluebird bio	Skysona (elivaldogene autotemcel)	To slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy	9/16/2022
bluebird bio	Zynteglo (betibeglogene autotemcel)	Treatment of adult and pediatric patients with ß-thalassemia who require regular red blood cell transfusions	8/17/2022
Johnson & Johnson (Janssen) and Legend Biotech	Carvykti (ciltacabtagene autoleucel)	Treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody	2/23/2022
argenx BV	Vyvgart (efgartigimod alfa-fcab)	Treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive	12/17/2021
On Target Laboratories	Cytalux (pafolacianine)	Optical imaging agent for use in adults with ovarian cancer as an adjunct for intraoperative identification of malignant lesions	11/29/2021
Takeda	Livtencity (maribavir)	Treatment of adults and pediatric patients 12 years of age and older and weighing at least 35 kg with post-transplant of cytomegalovirus infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or fascarnet	11/23/2021
BioMarin	Voxzogo (vosoritide)	Treatment of pediatric patients aged five years and older with achondroplasia and open epiphyses	11/19/2021
Ascendis Pharma	Skytrofa (lonapegsomatropin-tcgd)	Treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone	8/25/2021
Sanofi (Genzyme)	Nexviazyme (avalglucosidase alfa-ngpt)	Enzyme replacement therapy that targets the mannose-6-phosphate receptor for treatment of patients one year of age and older with late-onset Pompe disease	8/6/2021
Jazz Pharmaceuticals	Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)	Asparagine specific enzyme as a component of multi-agent chemotherapy regimen for treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have hypersensitivity to E coli-derived asparaginase	6/30/2021

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