Novartis has claimed accelerated approval from the FDA for Vanrafia, one of a trio of therapies it hopes will revolutionise the treatment of rare kidney disease IgA nephropathy (IgAN).

The FDA has approved Alnylam’s gene silencing drug Oxlumo, the first treatment for primary hyperoxaluria type 1 (PH1), an ultra-rare and life-threatening genetic disorder.

FDA denies Unicycive's NDA for Oxylanthanum Carbonate due to vendor issues; company eyes quick resolution with alternate ...

Novartis shares climb on strong Cosentyx sales, franchise growth, and a new malaria drug approval despite political risks.

The U.S. Food & Drug Administration (FDA) has granted approval for a new subcutaneous autoinjector formulation of belimumab (Benlysta®) treatment for children ages five years and older with active ...

Amarna Therapeutics and NorthX Biologics finalized an agreement to advance Nimvec AM510 gene therapy toward clinical trials for Type 1 Diabetes. Now in its fourth year, the MM+M Media Summit brings ...

The FDA approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show prevents new infections.

Patients with migraine discontinued treatment less often with atogepant and experienced a greater reduction in mean monthly ...

According to the latest study from BCC Research, "Global Cancer Therapeutics Market: Emphasis on Recurrent and Metastatic ...

Former FDA chief Dr. David Kessler says the new weight-loss drugs are a powerful tool to fight obesity. But they come with pitfalls. Here's his tips for how to use them successfully.

The biotech sector remains one of the most dynamic areas of the market, driven by clinical breakthroughs, regulatory decisions, and disruptive innovations. Over the years, large pharmaceutical ...