NDA News-CliniExpert

FDA Approves Iyuzeh (latanoprost ophthalmic solution) for the Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

Iyuzeh™ (latanoprost ophthalmic solution) 0.005% is the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA) in the United States LEXINGTON

FDA Approves Krazati (adagrasib) for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation

SAN DIEGO, Dec. 12, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a targeted oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated

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