FDA Approves Rezlidhia (olutasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with a Susceptible IDH1 Mutation
Rezlidhia is a potentially market-leading, oral, mutant isocitrate dehydrogenase-1 (mIDH1) inhibitor Phase 2 registrational data supporting the approval showed a 35% CR+CRh rate in mIDH1 R/R AML patie
FDA Approves Rebyota (fecal microbiota, live-jslm) Microbiota-Based Live Biotherapeutic for the Prevention of Recurrence of Clostridioides Difficile Infection
Ferring’s novel first-in-class Rebyota is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatmen
FDA Approves Hemgenix (etranacogene dezaparvovec-drlb) Gene Therapy for Hemophilia B
This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX le
FDA Approves Tzield (teplizumab-mzwv) to Delay the Onset of Stage 3 Type 1 Diabetes
Tzield is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease In a clinical trial, in Stage 2 T1D patients, Tzield delayed the median onset of Stage 3 T1D by 25 months, o
FDA Approves Elahere (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer
Elahere is the First ADC Approved by FDA for Platinum-Resistant Ovarian Cancer Indication Covers Patients with One to Three Prior Systemic Treatment Regimens, Regardless of Prior Avastin® Use VENTANA
FDA Approves Tecvayli (teclistamab-cqyv) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Tecvayli, an off-the-shelf, subcutaneous therapy, is an important new medicine for patients with incurable blood cancer who face limited treatment options HORSHAM, Pa., October 25, 2022 – The Janssen
FDA Approves Imjudo (tremelimumab) in Combination with Imfinzi for Patients with Unresectable Hepatocellular Carcinoma
24 October 2022 -- AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with unresectable hepatocellular carcino
FDA Approves Furoscix (furosemide injection) for the At-Home Treatment of Congestion Due to Fluid Overload in Chronic Heart Failure
Furoscix demonstrated 99.6% bioavailability and produced similar diuresis and natriuresis compared to intravenous furosemide BURLINGTON, Mass., Oct. 10, 2022 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc.
FDA Approves Lytgobi (futibatinib) for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma
Lytgobi (pronounced “light-GOH-bee”) delivered an objective response rate of 42% and median duration of response of 9.7 months in the primary analysis of the pivotal clinical trial. Lytgobi covalently
FDA Approves Relyvrio (sodium phenylbutyrate/taurursodiol) for Patients with Amyotrophic Lateral Sclerosis (ALS)
Relyvrio (previously known as AMX0035 in the U.S.) is an oral, fixed-dose combination therapy for the treatment of adults with ALS Relyvrio significantly slowed loss of physical function in a randomiz
FDA Approves Iheezo (chloroprocaine hydrochloride ophthalmic gel) for Ocular Surface Anesthesia
Iheezo Represents the First Approved Use in the U.S. Ophthalmic Market of Chloroprocaine Hydrochloride and the First Branded Ocular Anesthetic Approved for the U.S. Ophthalmic Market in Nearly 14 Year
FDA Approves Vegzelma (bevacizumab-adcd), a Biosimilar to Avastin
Vegzelma is Celltrion’s third oncology biosimilar to receive approval from the U.S. FDA Vegzelma offers U.S. patients living with multiple types of cancer a new, safe, and effective treatment option T
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