First biologic approved for this rare autoimmune blistering skin disease; pivotal trial data drive swift Priority Review.
First biologic approved for this rare autoimmune blistering skin disease; pivotal trial data drive swift Priority Review.
Cycle Pharmaceuticals’ CEO calls approval “a defining moment for patients, physicians and science—proving unmet metabolic needs can be …
Once-monthly subcutaneous treatment offers new option for preventing hereditary angioedema attacks across all patient types from therapy initiation.
Clinical trial results underscore safety and diagnostic accuracy for radiopharmaceutical imaging; Clarity pursues regulatory filings and wider manufacturing …
This approval adds a key anti-inflammatory eye drop to Amneal’s Affordable Medicines portfolio, with a commercial launch planned …
The FDA’s June 9 drug approvals bring new preventive options for infants at risk of RSV, innovative combination …
U.S. regulators expand treatment options in prostate cancer as biotech innovators TRexBio and Spinogenix push forward with immune …
FDA’s Oncologic Drugs Advisory Committee (ODAC) critiques a major lymphoma trial for having too few U.S. participants, warning …
Novavax’s protein-based COVID-19 vaccine, Nuvaxovid, wins FDA approval for older adults and people with underlying health risks under …
A new antibody-drug conjugate brings hope for patients with lung cancer who have few options
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