Acadia Pharmaceuticals announced that the FDA has approved Daybue Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome… read more.
Axogen, Inc. announced that the FDA has approved the Biologics License Application (“BLA”) for Avance (acellular nerve allograft-arwx). Avance is an acellular nerve scaffold for the treatment of… read more.
Insulet Corporation, a global leader in tubeless insulin pump technology with its Omnipod brand of products, today announced it has received FDA 510(k) clearance for significant enhancements to… read more.
CSL announced five-year (60-month) results from the pivotal Phase III HOPE-B study, confirming the long-term durability and safety of a one-time infusion of Hemgenix (etranacogene dezaparvovec-drlb) in adults… read more.
Fresenius announced the launch of its denosumab biosimilars, Conexxence (denosumab) and Bomyntra (denosumab), in Europe. These biosimilars received approval from the European Commission in July 2025 for all… read more.
Eli Lilly and Company announced that the FDA approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for subcutaneous use in adults with moderately to… read more.
Insmed announced that the European Commission has approved Brinsupri (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and… read more.
Roche announced that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted FDA 510(k) clearance and Clinical Laboratory Improvement… read more.
Amgen and AstraZeneca announced that the FDA approved Tezspire (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric… read more.
NICE (UK): Darolutamide with androgen deprivation therapy (ADT) can be used as an option to treat hormone-sensitive metastatic prostate cancer in adults, only if: i) docetaxel is not… read more.
Sandoz announced the European launch of Wyost (denosumab 120 mg) and Jubbonti (denosumab 60 mg). The medicines are among the first denosumab biosimilars to launch in Europe and are approved… read more.
GE HealthCare announced CE Mark for its next-generation Omni 128cm total body positron emission tomography / computed tomography (PET/CT) system, a major milestone in its mission to advance… read more.
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