Posts in category: News

FDA Approves Rytelo for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia June 6, 2024 – Geron Corporation has announced that the U.S. Food and Drug Administration (FDA) has  approved Rytelo™ (imetelstat) for the treatment of adult patients:

• with low- to intermediate-1 risk myelodysplastic syndromes (MDS),

• with transfusion-dependent (TD) anemia requiring four or more red blood cell units over eight weeks,

• who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

Rytelo is a first-in-class treatment that works by inhibiting telomerase enzymatic activity, and It is indicated to be administered as an intravenous infusion over two hours every four weeks.

Source: Geron Corporation

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FDA Approves mRESVIA for Prevention of Lower Respiratory Tract Disease Caused by RSV

The FDA has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

• The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna. The vaccine uses the same lipid nanoparticles (LNPs) as  the Moderna COVID-19 vaccines.

• Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.

Source: Moderna, Inc.

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FDA Approves Onyda XR Non-Stimulant Liquid Treatment for ADHD

The FDA has approved Onyda XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

• The FDA approval of Onyda XR is based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets.
• Onyda XR is the first non-stimulant ADHD medication in Tris’ portfolio, the first-and-only liquid non-stimulant ADHD medication approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing.
• Tris Pharma harnessed the flexibility of its proprietary LiquiXR® technology to develop Onyda XR, a
  liquid non-stimulant medication with a smooth, extended-release profile that physicians can use to treat ADHD patients either alone or in combination with stimulant therapy.

Source: Tris Pharma News and Media

The FDA has approved Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye.

The FDA also approved Opuviz (aflibercept-yszy), an interchangeable biosimilar to Eylea (aflibercept). Both Yesafili and Opuviz are the first interchangeable biosimilars to Eylea to treat certain eye conditions.
They are used to treat:

• Neovascular (wet) age-related macular degeneration
• Macular edema following retinal vein occlusion
• Diabetic macular edema
• Diabetic retinopathy
  Source: FDA

FDA Grants Accelerated Approval for Imdelltra for the Treatment of Extensive-Stage Small Cell Lung Cancer

The FDA has approved Imdelltra™ (tarlatamab-dlle), manufactured by Amgen, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

• Imdelltra is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the
  patient’s own T cells to attack DLL3-expressing tumor cells.
• Imdelltra is administered as an intravenous infusion over one hour in an appropriate hospital
  setting.

Source: Amgen

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