Successful Type B RDEP Meeting confirms FDA alignment on pivotal Phase 3 study designFDA indicates Opus Genetics may submit a BLA based on ...

The FDA has issued a warning letter to China-based continuous positive airway pressure (CPAP) device maker BMC Medical.

Seven pharma companies have been selected for the FDA PreCheck pilot – a framework intended to bolster the US drug supply ...

Heat and Control will debut its new metal detector, CEIA THS/210-MBH9, to local food processors at foodpro 2026.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), today announced its acceptance into the U.S ...

Replimune Group, Inc. nears a pivotal FDA AdCom for RP1 ahead of an Aug 2, 2026 decision. Click for this REPLY stock update ...

A new study suggests inexpensive AI could reshape healthcare’s business model by helping patients use LLMs to manage and ...

All the small things, true care, truth brings,” sang Blink-182 and, in the world of medical devices, it is the small things that can bring ...

Strategic collaboration at Sanford, North Carolina facility, currently under construction, to optimize cGMP validation, accelerate time-to-market for complex biologics, and shore up U.S. medicine ...

Adults with blood cancers who receive stem cell transplants from matched donors now have a new defense against one of the ...

The U.S. Food and Drug Administration (FDA) recently announced a pilot program for "One-Day Inspectional Assessments," a new ...

The FDA provided favorable feedback on NewcelX’s Chemistry, Manufacturing, and Controls (“CMC”) processes and preclinical program allowing the Company to proceed toward its Investigational New Drug ...