The US Food and Drug Administration (FDA) has approved Element Science’s premarket approval application for its Jewel Patch ...

The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson's drug to treat a type of muscle-weakening ...

The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...

The FDA is expected to decide on treatments for bullous pemphigoid, hereditary angioedema, HIV PrEP, ovarian cancer, and RSV.

The FDA has issued a Complete Response Letter to Telix Pharmaceuticals regarding the NDA for TLX101-CDx for the imaging of gliomas.

The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...

Dechra Announces FDA Approval of Otiserene® (marbofloxacin, terbinafine, and dexamethasone otic suspension) the latest ...

In a phase 3 trial, 81% of wounds treated with autologous cell sheet-based gene therapy showed ≥ 50% healing at 6 months, ...

Here is a recap of every FDA approval announced by the regulatory agency in the month of April, spanning various cancer types ...

The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia ...