FDA approves drug from Boston-based company to treat pain without opioid effects
The drug, suzetrigine, made by Boston-based Vertex Pharmaceuticals and to be sold as Journavx, works only on nerves outside ...
FDA approves new type of non-opioid pain medication
The U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) oral tablets on Thursday as a first-in-class ...
BioPharma Dive1d
Enhertu, with new OK, set to supplant chemo in HER2-low breast cancer
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
JD Supra2d
FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
verywellhealth3d
Spravato Nasal Spray Can Now Be Used Alone for Treatment-Resistant Depression
People with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.
JD Supra3d
FDA Releases Proposed Front-of-Package Nutrition Labeling Rule
On January 16, 2025, the U.S. Food and Drug Administration (“FDA”) published a highly anticipated proposed rule on front-of-package (“FOP”) ...
Truthout4d
Trump Aims to Overhaul the FDA. What Does That Mean for Public Health?
Meanwhile, in an executive order, Trump created his long-discussed “Department of Government Efficiency,” to be led by Elon ...
Pharm Exec4d
FDA Grants Priority Review to Merck’s Welireg for Advanced, Unresectable, or Metastatic Pheochromocytoma, Paraganglioma
Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in ...
ConsumerAffairs4d
FDA upgrades Costco salmon recall to Class I
The U.S. Food and Drug Administration has upgraded a recall of salmon sold at Costco to Class I, its highest threat level.
manilatimes4d
Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis
"This SPA agreement marks an important milestone in the development of Descartes-08 for MG, providing critical regulatory clarity and a clear path toward potential approval,” said Carsten Brunn, Ph.D.
manilatimes4d
FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease
LEQEMBI ® [ (lecanemab-irmb) 100 mg/mL injection for intravenous use] is indicated for the treatment of Alzheimer's disease (AD). Treatment with LEQEMBI should be initiated in patients with mild ...