Anaphylaxis Alert: New Safety Concerns Emerge for Glatiramer Acetate
Glatiramer acetate, a drug approved in 1996, for the treatment of Multiple sclerosis, is currently facing increased scrutiny from the FDA due to serious concerns. What is Multiple sclerosis? Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system, specifically the brain and spinal cord. In MS, the immune system mistakenly attacks […]
Based on Phase 3 trial data, the FDA approved Alhemo for the treatment of hemophilia-related bleeding
On December 20, 2024, FDA approved Alhemo (concizumab-mtci) injection to reduce the hemophilia related bleeding frequency in patients of 12 years and older. This is a first of its kind subcutaneous injection treatment for patients suffering from hemophilia A with factor 8 inhibitors or hemophilia B with factor 11 inhibitors Who is the treatment target? […]
FDA Certifies Vyloy as a Novel Approach Against Gastric Cancer: a CLDN18.2-Targeted Therapy
On October 18, 2024, FDA approved Vyloy (zolbetuximab-clzb) as the first and only claudin-18.2-targeted antibody to treat gastric cancer. The drug has been approved to be used in combination with fluoropyrimidine and platinum containing chemotherapy for patients suffering from locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction […]
Recent FDA Approvals pack Double punches against Niemann-Pick disease type C
Rare diseases, affecting fewer than 200,000 people in the U.S., pose significant challenges due to their low prevalence. According to the NIH, there are over 7,000 known rare diseases, each with unique symptoms and treatments. For example, cystic fibrosis, a genetic disease affecting the lungs, often goes misdiagnosed. The lack of large patient populations hinders […]
Redefining the Standard of Care: Lazertinib and Amivantamab for NSCLC
The FDA has approved lazertinib (Lazcluze) in combination with amivantamab-vmjw (Rybrevant) for the first-line treatment of non-small cell lung cancer with specific genetic mutations. In a significant advancement for the treatment of non-small cell lung cancer (NSCLC), the U.S. Food and Drug Administration (FDA) has granted approval to lazertinib (Lazcluze) when used in combination with […]
Tasty Traps: FDA and FTC Warn Against Copycat Snack Containing Delta-8 THC
FDA and FTC crack down on illegal delta-8 THC copycat snacks, protecting consumers from unregulated edibles in deceptive packaging that risks accidental ingestion, especially by children Imagine opening a yellow and orange pack of Flamin’ hot Cheetos and munching on one of those crunchy sticks. Instead of the cheesy, salty taste of nostalgia, you start […]
Slimmer Days Ahead? Roche’s New Obesity Drug Shows Potential
Roche’s oral GLP-1 receptor agonist demonstrates significant weight loss in Phase I study. The global prevalence of obesity has surged dramatically over the past half century, driving a corresponding increase in pharmaceutical development within this therapeutic area. This week, Roche introduced a new treatment option, marking a significant advancement in the management of obesity. Facts […]
Forget Me Not: New Alzheimer’s Drug from Eli Lilly Gets FDA Nod
The FDA approved donanemab, a new drug for early-stage Alzheimer’s disease. I remember my grandmother, her summer house filled with the smell of freshly baked cookies, the air vibrating with the laughter of my cousins rolling on the floor from her silly jokes. It was the best time of our childhood. I wish it remained […]
Iqirvo Clears FDA Hurdle, Offering New Relief for Primary Biliary Cholangitis Patients
The FDA approves Iqirvo (elafibranor) for primary biliary cholangitis (PBC) treatment, offering a new option for patients intolerant to UDCA. What is Primary Biliary Cholangitis (PBC)? A case study from December 2023 reports a 19-year-old male with multiple congenital abnormalities and an intellectual disability suffered from pruritus for 5 years. Tests revealed elevated levels of […]
Breaking Barriers in Rare Disease Treatment: FDA Approves Bkemv as First Interchangeable Biosimilar
The US Food and Drug Administration (FDA) has approved Amgen’s Bkemv as the first interchangeable biosimilar to Soliris for treating rare diseases, such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The FDA has approved Bkemv, a biosimilar, as the first interchangeable treatment for two rare and debilitating diseases: paroxysmal nocturnal hemoglobinuria […]
FDA Greenlights mRESVIA: Moderna’s Breakthrough in RSV Prevention
Moderna’s mRESVIA, an mRNA vaccine, has received FDA approval, a significant milestone in the fight against respiratory syncytial virus (RSV). June 9th, 2024: In a significant development for public health, Moderna has received approval from the U.S. Food and Drug Administration (FDA) for its new respiratory syncytial virus (RSV) vaccine, mRESVIA. This marks a major […]
Eyeing a Brighter Future: Two New Biosimilars Approved for Macular Edema
FDA approves biosimilars Yesafili and Opuviz for Diabetic Macular Edema, offering affordable treatment options. Breakthrough in Diabetic Macular Edema Treatment May 25th, 2024: The FDA’s recent approval of two new biosimilars, Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy), marks a significant breakthrough in the treatment of Diabetic Retinopathy. These biosimilars are interchangeable with Eylea (Aflibercept), a biologic […]
