Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three ...

Ori Biotech has lassoed a significant milestone for its space- and cost-efficient cell and gene therapy manufacturing ...

Aug. 7 (UPI) --The U.S. Food and Drug Administration announced Thursday it is launching the "FDA PreCheck" program in order to help construct drug manufacturing sites in the United States. "Our ...

The Food and Drug Administration has issued a stern warning to Amneal Pharmaceuticals for what it called “significant violations” of manufacturing standards, citing instances in which the drugmaker ...

Pharmaceutical Technology serves as the connection to bio manufacturing and development, featuring regulatory updates and ...

The US Food and Drug Administration (FDA) has launched a new scheme that will streamline the introduction of new pharmaceutical manufacturing facilities in the US, a strategy in line with US President ...

Indian drugmaker Sun Pharmaceutical Industries said on Tuesday the U.S. Food and Drug Administration had determined that its ...

The PDA Regulatory Conference convenes more than 30 FDA experts to discuss cGMP excellence, compliance trends, and regulatory outlook, offering crucial insights for pharma manufacturing professionals.

Perhaps the most interesting of the pile of FDA rejection letters was for Lykos Therapeutics’ MDMA therapy. Letters sent to ...

The crackdown from the U.S. Food and Drug Administration could snuff out Breeze Smoke, a 6-year-old company based in Hazel ...