Pharma News

Syngene announced a significant extension of its long-standing collaboration with global biopharmaceutical leader Bristol Myers Squibb (BMS). The renewed strategic agreement will now continue through 2035, marking a new decade of deep partnership aimed at driving drug discovery, development, and commercialization.

The U.S. Food and Drug Administration (FDA) has issued an official warning letter to Genetrace, a company based in Blaine, Washington, for offering an HIV diagnostic self-collection kit to U.S. customers without proper authorization.

According to the FDA, the product in question is a dried blood spot (DBS) card self-collection kit that people use at home to collect blood samples and send them to a lab for HIV testing. The agency says this kit qualifies as a medical device because it is meant to help diagnose disease.

A new scientific review highlights the rapid evolution of microneedle technology as a versatile and minimally invasive platform for delivering biomacromolecules—large therapeutic molecules used to treat major diseases, including cancer, cardiovascular conditions, metabolic disorders, infections, and autoimmune diseases.

Zydus Lifesciences Limited has completed the acquisition of biologics manufacturing facilities from U.S.-based Agenus Inc., marking a major step in its global biologics and contract development and manufacturing (CDMO) strategy. Following regulatory clearances, including approval from the Committee on Foreign Investment in the United States (CFIUS), the acquired assets will operate under a newly formed U.S. subsidiary, Zylidac Bio LLC.

Sentynl Therapeutics Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ZYCUBO® (copper histidinate) for the treatment of patients with Menkes disease, a rare, inherited disorder that affects copper absorption and distribution in the body.