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Arkayli Biopharma Inc. Receives FDA Study May Proceed Response to IND and NIH SBIR Grant to Advance Clinical Development of ARK001 for a Rare Pediatric Disease

Arkayli BioPharma Inc. a biopharmaceutical company dedicated to developing innovative therapies for rare dermatologic conditions, announced that the U.S. Food and Drug Administration (FDA) has responded to its Investigational New Drug (IND)...

Aptar Pharma Launched Premia™ Precision, Establishing a New Quality Standard for Demanding Injectable Therapies

Aptar Pharma, a global leader in drug delivery, dosing, protection technologies and services, announced the launch of Premia™ Precision, a new quality standard for elastomer components, designed to support sensitive and high-value injectable...

FDA Updates WINREVAIR™ Label with HYPERION Phase 3 Trial Data in Adults Newly Diagnosed with PAH

Merck known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg, based on the Phase 3...

StimCardio’s NeuroPulse Study Reports a Substantial Reduction in Recurrent Atrial Fibrillation Events Following Ablation Using Non-Invasive Wearable Neuromodulation

StimCardio Medical announced positive results from the randomized, double-blind, sham-controlled NeuroPulse pilot study evaluating non-invasive median nerve stimulation (MNS) following atrial fibrillation (AF) ablation. The study was selected for...

Stasis Introduces the First Day-and-Night Supplement System Built for Children Who Take Stimulants

Stasis, the company behind the first supplement system designed to be taken alongside stimulants, today introduced Stasis Kids, a day-and-night nutritional supplement system made for children ages 6 to 17. In 2023, 16.5 million people in the...

Neurolief Advances Veteran Mental Health and Migraine Care With New VA Contract for Prescription Neuromodulation

Neurolief, a neuroscience-driven medical technology company developing brain neuromodulation therapies for mental health and neurological conditions, is bringing two prescription therapies to U.S. veterans through a new Department of Veterans...

Takeda's ORZEYFUL™ Receives U.S. FDA Approval for Narcolepsy Type 1

Takeda announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent...

Why the Pharmacy System Rewards the Wrong Results: It Is Working as Designed

Pharmacy costs are consuming a growing share of employer healthcare budgets, but high drug prices and opaque contracts do not explain the entire problem. Employers continue to face spending above expectations despite rebate guarantees, contractual...

Erbitux® (cetuximab) in Combination with Encorafenib and FOLFOX Approved by the European Commission as a First-Line Treatment for BRAF V600E-Mutant Metastatic Colorectal Cancer

Merck, a leading global science and technology company, announced that the European Commission (EC) approved an update to the Erbitux (cetuximab) EU label on June 26, 2026. Erbitux is now indicated in combination with encorafenib for patients with...

FDA Approves Expanded Indication for Octapharma USA's wilate® for Prophylaxis of von Willebrand Disease in Children Younger Than 6 Years

On July 2, 2026, the U.S. Food and Drug Administration (FDA) approved the use of wilate® (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) for routine prophylaxis to reduce the frequency of bleeding episodes in pediatric patients...

CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) Receives U.S. FDA Approval for an Additional Indication in Children and Adolescents Aged 2–17 Years at Increased Risk for Pneumococcal Disease

Merck known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) to include children and...

Rugiet Launched Physician-Prescribed Peptide and Longevity Therapies, Setting a New Standard in Performance Medicine

Rugiet, the performance medicine company that’s helped more than 500,000 men take control of their health, announced the expansion of its treatment areas to include longevity. Rugiet is bringing its physician-prescribed standards to an emerging...

Results from Incyte’s Phase 3 frontMIND Trial of Tafasitamab Combination Show Prolonged Progression-Free Survival Presented at EHA 2026

Incyte announced positive results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®/Minjuvi®), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, and lenalidomide added to...

BEACON Real-World Study Shows Positive Top-Line Results for ZUNVEYL® in Alzheimer’s Disease, Reports Alpha Cognition

Alpha Cognition Inc. a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, announced the top-line results from its BEACON real-world study evaluating provider-reported cognitive, behavioral,...

Lundbeck Receives Marketing Authorization in South Korea for Vyepti® (eptinezumab) for the Preventive Treatment of Migraine

H. Lundbeck A/S (Lundbeck) announced that the Ministry of Food and Drug Safety (MFDS) of South Korea has granted marketing authorization for eptinezumab for use in adults with migraine. Migraine is a progressive and debilitating neurological...

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