Proper survival and regeneration of retinal ganglion cells (RGCs), which constitute the optic nerve, is crucial for managing traumatic or ischemic optic nerve injury, optic neuropathy, or optic ...

Tanvex Biopharma Inc. said its U.S. subsidiary, Tanvex Biopharma U.S.A. Inc., received an FDA complete response letter (CRL) on Jan. 3 for its TX-05 BLA, a biosimilar that references Roche AG’s ...

South Korea’s government continued to ramp up investment in its pharmaceutical and med-tech sector in 2025, including a 7.2% ...

The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and ...

Aromatase inhibitors (AI) are among the most widely used therapies in the treatment of breast tumors expressing estrogen ...

Strong interim safety and efficacy data from Hoth Therapeutics Inc.’s phase IIa study of HT-001 helped boost the company’s stock (NASDAQ:HOTH) on Jan. 7 as shares rose 178% to close at $2.28 each.

Medtronic plc received CE mark approval for its Harmony transcatheter pulmonary valve system to treat congenital heart disease patients with native or surgically repaired right ventricular outflow ...

Sun Pharmaceutical Industries Ltd. has divulged incretin analogues acting as dual agonists of gastric inhibitory polypeptide (GIPR) receptor/GLP-1 or GLP-1/glucagon receptor (GCGR) or triple agonists ...

What does it mean for a confirmatory trial to be “underway”? That’s a question that’s been plaguing some drug sponsors, especially those in the ultra-rare disease space, since the U.S. Congress, in ...

The question of how skin pigmentation affects the performance of pulse oximeters has drawn the U.S. FDA’s close attention for several years, and the agency issued a draft guidance to address these ...

The discussion about taxpayer appropriations for CMS has been ongoing for decades, leading to futile speculation regarding user fees for the agency. Louis Jacques, who formerly worked at CMS, told ...

Ibio Inc. has expanded its cardiometabolic and obesity treatment development program by in-licensing a long-acting anti-myostatin antibody from Astralbio Inc. The antibody, now named IBIO-600, was ...