The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April ...

FDA approval represents more than a regulatory milestone; it’s a leap forward in how we, as clinicians, think about using cutting-edge therapeutic technology to empower patients to live their fullest ...

"If you are seeking information about a drug that is not approved, this information is confidential but may be publicly disclosed by the sponsor." "Any delays in drug approvals are the result of ...

The company plans to file for FDA approval of its drug, called cytisinicline, in June. Rick Stewart, Achieve’s co-founder and CEO, told STAT that he expects the drug to be approved in mid-2026 ...

On April 30, 2025, the FDA approved nipocalimab-aahu (Imaavy; Johnson & Johnson), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG) in adult and ...

The Food and Drug Administration on Wednesday approved an antibody drug that developer Johnson & Johnson expects will eventually become one of its top-selling medicines. The drug, which J&J will sell ...

The U.S. Food and Drug Administration (FDA) on Tuesday approved Abeona Therapeutics Inc.’s (NASDAQ:ABEO) Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel ...

This approval marks a historic moment for the EB community as the third FDA approved treatment and the first autologous, cell-based gene therapy for RDEB (Recessive Dystrophic Epidermolysis Bullosa).

Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine after the agency grants full approval. The company said it had responded and ...

FDA approval of Tepylute provides a ready-to-dilute thiotepa formulation for breast and ovarian cancer treatment, enhancing convenience and reducing preparation errors. The new formulation eliminates ...

File this under “So close, yet so far.” After several years of struggling with regulatory hurdles to win approval for its rare disease drug, Stealth BioTherapeutics had expected the U.S. Food ...