The FDA’s collaboration with the U.S. Patent Trade Office (USPTO) to bring down barriers that delay generics is off to a good start, according to FDA Commissioner Robert Califf, who points to drug ...

CurvaFix has received FDA’s 510(k) clearance for an updated version of its CurvaFix IM implant for smaller patients with fractures of the pelvis. Based on surgeon feedback, the company redesigned the ...

Spanish drugmaker SOM Biotech has received an Orphan Drug designation from the FDA for SOM3355 (bevantolol hydrochloride), an experimental drug for treating a movement disorder in patients with ...

Illumina said it will appeal a Federal Trade Commission (FTC) order to divest itself of Grail — developer of the Galleri early detection liquid biopsy test to screen for multiple types of cancer.

Texas-based Dalton Medical, a manufacturer of powered wheelchairs, adjustable hospital beds and other durable medical equipment, received a Form 483 for failure to establish design control and ...

UK-based liquid biopsy company Angle said its Parsortix system delivered promising results in a proof of concept study that demonstrated that removal of plasma from a blood sample did not affect the ...

Women with breast or ovarian cancer had fewer hot flashes, less psychiatric distress and better quality of life after using XRHealth’s virtual reality (VR)-artificial intelligence (AI)- based ...

The FDA granted Hologic’s Aptima CMV Quant assay premarket approval for quantifying the viral load of cytomegalovirus in patients who have had solid organ or stem cell transplants. The test for ...

Roche has secured European Commission approval for Enspryng (satralizumab) for treating adolescents and adults with neuromyelitis optica spectrum disorder (NMOSD), a central nervous system condition ...

The FDA has issued Soligenix a Refusal to File letter for its HyBryte (synthetic hypericin) new drug application (NDA), deeming it not sufficiently complete for a substantive review. Soligenix said it ...

Invitae’s in vitro diagnostic test that uses a blood sample to help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers has received de novo marketing ...

The FDA has issued a nine-observation Form 483 to Sacks Holdings, based on an inspection last December of the company’s facility in San Diego, Calif. The investigator noted Sacks lacked a design ...