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
FDA Approves Omlonti (omidenepag isopropyl ophthalmic solution) for Reduction of Elevated Intraocular Pressure in Primary Open-Angle Glaucoma or Ocular Hypertension
EMERYVILLE, Calif. & UBE, Japan--(BUSINESS WIRE) September 26, 2022 --Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE) today announced that t
FDA Approves Pedmark (sodium thiosulfate injection) to Reduce Risk of Ototoxicity Associated with Cisplatin
Pedmark is the First and Only FDA-Approved Therapy Indicated to Reduce the Risk of Ototoxicity Associated with Cisplatin in Pediatric Patients with Localized, Non-Metastatic Solid Tumors RESEARCH TRIA
FDA Approves Aponvie (aprepitant) for the Prevention of Postoperative Nausea and Vomiting (PONV)
Aponvie is the first and only intravenous (IV) formulation of a substance P/neurokinin-1 (NK1) receptor antagonist indicated for PONV Delivered via a single 30-second IV injection, Aponvie has demonst
FDA Approves Skysona (elivaldogene autotemcel) Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)
Skysona is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys with this devastating and fatal neurodegenerative disease SOMERVILLE, Mass.--(BUSINESS WIRE)--
FDA Approves Terlivaz (terlipressin) for the Treatment of Hepatorenal Syndrome (HRS)
DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz
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