Explore

Rapid Read Rapid Read
Takeda's MIMRYLO™ (rusfertide) Approved by U.S. FDA for Polycythemia Vera Erythrocytosis

Takeda's MIMRYLO™ (rusfertide) Approved by U.S. FDA for Polycythemia Vera Erythrocytosis

Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution and red blood cell overproduction, aiming to control hematocrit levels. Maintaining hematocrit below 45% is the primary treatment goal for PV patients to prevent life-threatening thrombotic events. The approval is supported by data from the global randomized Phase 3 VERIFY study, which included 293 PV patients. The study showed that MIMRYLO, combined with standard of care, resulted in a higher response rate, reduced phlebotomy needs, and improved fatigue compared to placebo. MIMRYLO is administered once weekly via subcutaneous injection and was generally well-tolerated in trials, with common adverse events being injection site reactions and anemia.
Rapid Read Rapid Read
FDA Approves Mimrylo for Polycythemia Vera, First-in-Class Treatment

FDA Approves Mimrylo for Polycythemia Vera, First-in-Class Treatment

The U.S. Food and Drug Administration (FDA) has approved Mimrylo (rusfertide), a new treatment for adults diagnosed with polycythemia vera, a rare blood disorder characterized by the overproduction of red blood cells. This condition can lead to thickened blood and an increased risk of cardiovascular complications such as blood clots, stroke, and heart attack. Mimrylo represents a first-in-class therapy, targeting the biological mechanisms that drive red blood cell overproduction. It mimics hepcidin, a hormone that naturally regulates iron levels in the body, thereby limiting the iron available for new red blood cell formation. This novel approach offers a new option for patients whose disease has not been adequately controlled by existing treatments, aiming to reduce the burden of frequent phlebotomies.
Rapid Read Rapid Read
Compass Pathways Seeks Director for U.S. Site of Care to Advance Psilocybin Therapy for PTSD

Compass Pathways Seeks Director for U.S. Site of Care to Advance Psilocybin Therapy for PTSD

Compass Pathways, a biotechnology company headquartered in London with a U.S. office in New Jersey, is actively developing COMP360 psilocybin, an investigational treatment for Post-traumatic Stress Disorder (PTSD) and treatment-resistant depression (TRD). COMP360 has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for TRD. The company is currently executing a late-stage trial for COMP360 in PTSD and is seeking a Director, National Site of Care in the United States. This role is crucial for establishing strategic relationships with organized care groups, health systems, and treatment centers that will serve as early adopters of COMP360 therapy. The Director will lead a team responsible for site-of-care execution, ensuring consistent account planning, customer engagement, and launch readiness activities across the U.S.
USA Today USA Today
Thyroid medicine recalled. See affected product

Thyroid medicine recalled. See affected product

A popular thyroid tablet medication has been recalled. Here's why and which product is affected.
Rapid Read Rapid Read
Divalproex Sodium Linked to Severe Fatalities and Adverse Events, Including Hypothermia

Divalproex Sodium Linked to Severe Fatalities and Adverse Events, Including Hypothermia

Divalproex sodium, a medication used for seizure control, mood stabilization, and migraine prevention, has been associated with severe and potentially fatal adverse events. These include severe fatal hepatotoxicity (liver failure), acute hemorrhagic pancreatitis, and severe hyperammonemic encephalopathy, which can manifest as confusion, lethargy, and hypothermia. The risk of fatal hepatotoxicity is particularly elevated in children under two years old, especially those with congenital metabolic disorders, severe seizure disorders with mental retardation, or organic brain disease. Patients with hereditary mitochondrial disease caused by mutations in the POLG gene also face an increased risk. The medication carries a black box warning from the FDA due to these serious risks, as well as the potential for major congenital malformations and decreased IQ scores if taken during pregnancy. Regular monitoring of liver function, blood counts, and metabolic screenings is crucial before and during treatment with dival...
AP News AP News
Juul gets OK to sell updated vaping device with age-gating technology

Juul gets OK to sell updated vaping device with age-gating technology

E-cigarette maker Juul Labs has received U.S. permission to sell an updated version of its vaping device
Rapid Read Rapid Read
CoRegen's CRG-150, a Gene-Edited Regulatory T-Cell Therapy, Cleared for Phase 1/2a Clinical Trial in Cancer

CoRegen's CRG-150, a Gene-Edited Regulatory T-Cell Therapy, Cleared for Phase 1/2a Clinical Trial in Cancer

CoRegen has received U.S. Food and Drug Administration (FDA) clearance for its Investigational New Drug (IND) application for CRG-150, a novel gene-edited regulatory T-cell (Treg) therapy. This clearance allows CoRegen to proceed with a first-in-human Phase 1/2a clinical trial (NCT07730125) for patients with metastatic triple-negative breast cancer, metastatic hormone receptor-positive/HER2-negative breast cancer, or metastatic prostate cancer. The therapy involves collecting a patient's own Tregs through apheresis, then using CRISPR-Cas9 gene editing to disrupt the NCOA3 gene, which produces the SRC-3 protein. This reprogramming aims to alter the Tregs' function from suppressing immune responses to actively promoting an anti-tumor immune environment. Unlike many existing cell therapies, CRG-150 does not require lymphodepleting chemotherapy prior to infusion, and the edited cells are intended to reshape the tumor microenvironment and recruit the patient's existing effector immune cells to fight the cancer.
Trendline Trendline
Federal Appeals Court Upholds FDA Decision Against Compounded Weight-Loss Drugs, Benefiting Novo Nordisk and Eli Lilly

Federal Appeals Court Upholds FDA Decision Against Compounded Weight-Loss Drugs, Benefiting Novo Nordisk and Eli Lilly

Federal Appeals Court Upholds FDA Decision Against Compounded Weight-Loss Drugs, Benefiting Novo Nordisk and Eli Lilly
Rapid Read Rapid Read
Northwest Naturals Voluntarily Recalls Raw Pet Food Due to Salmonella and Listeria Contamination

Northwest Naturals Voluntarily Recalls Raw Pet Food Due to Salmonella and Listeria Contamination

Northwest Naturals of Portland, Oregon, has voluntarily recalled 53 cases (1,272 lbs.) of its Frozen Chicken Recipe cat food (2 lbs. bags) and 19 cases (684 lbs.) of its Frozen Raw Diet for Dogs Chicken Recipe (6 lbs. bags). The recall was initiated due to potential contamination with Salmonella and/or Listeria monocytogenes. The U.S. Food and Drug Administration (FDA) identified the contamination after testing product samples, with the cat food testing positive for Salmonella and the dog food testing positive for both Salmonella and Listeria monocytogenes. The affected products are from specific lots: Northwest Naturals Frozen Chicken Recipe (cat food) Lot B-5 with a Best By date of 01/26/2028 and UPC 087316384956; and Northwest Naturals Frozen Raw Diet for Dogs Chicken Recipe (dog food) Lot B-19 with a Best By date of 01/25/2028 and UPC 087316380392. These products were distributed to retail stores nationwide. No illnesses have been reported to date in connection with this voluntary recall.
Rapid Read Rapid Read
Eli Lilly's Mounjaro Receives FDA Approval to Reduce Cardiovascular Risk in Type 2 Diabetes Patients

Eli Lilly's Mounjaro Receives FDA Approval to Reduce Cardiovascular Risk in Type 2 Diabetes Patients

Eli Lilly's Mounjaro (tirzepatide) has received U.S. FDA approval to reduce the risk of cardiovascular death, heart attack, or stroke in adults with type 2 diabetes (T2D) who are at high risk for these cardiovascular events. This approval makes Mounjaro the first dual GIP and GLP-1 receptor agonist to achieve this indication. Mounjaro was already approved for improving blood sugar in T2D patients. The new approval is supported by data from the SURPASS-CVOT trial, which involved 13,000 participants over more than four and a half years. The trial compared Mounjaro to Lilly's Trulicity, a GLP-1 treatment with established cardiovascular benefits, demonstrating Mounjaro's non-inferiority and an 8% lower rate of major adverse cardiovascular events (MACE-3) compared to Trulicity.
Trendline Trendline
Superbrewed Food Introduces Shelf-Stable Postbiotic Thryvia for Digestive and Immune Health

Superbrewed Food Introduces Shelf-Stable Postbiotic Thryvia for Digestive and Immune Health

Superbrewed Food Introduces Shelf-Stable Postbiotic Thryvia for Digestive and Immune Health
Trendline Trendline
AstraZeneca and Amgen's Tezspire Shows Promise for Eosinophilic Esophagitis, Paving Way for Label Expansion

AstraZeneca and Amgen's Tezspire Shows Promise for Eosinophilic Esophagitis, Paving Way for Label Expansion

AstraZeneca and Amgen's Tezspire Shows Promise for Eosinophilic Esophagitis, Paving Way for Label Expansion