Biden Rule Cleared Hurdles to Lifesaving HIV Drug, but Barriers Remain in Georgia
A new rule requires insurers to improve coverage of PrEP, which can prevent HIV, but Georgians face challenges getting the ...
pharmaphorum4h
FDA clears new antibiotic for superbug infections
AbbVie has claimed FDA approval for Emblaveo, a new antibiotic product to treat complicated intra-abdominal infections (cIAI) ...
Healio6d
FDA clears first assay designed to measure lipoprotein(a) in nanomoles
Roche announced its next generation assay received FDA 510(k) clearance for the measurement of lipoprotein(a) for assessment ...
Targeted Oncology3d
FDA Grants 225Ac-SSO110 Orphan Drug Status in SCLC
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
EssilorLuxottica receives FDA clearance for its Nuance audio glasses
EssilorLuxottica said on Monday it received a green light from the U.S. Food and Drug Administration (FDA) for its ...
JD Supra2d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
FDA clears migraine device for children as young as 8
A device long used by adults to manage migraines was now available for children as young as eight years old, offering new ...
COUR Pharmaceuticals Secures FDA Clearance of IND Application for CNP-103 in Type 1 Diabetes
COUR Pharmaceuticals, a clinical-stage biotechnology company developing first-in-class, disease-modifying therapies designed ...
Healio5d
FDA grants 510(k) clearance to AI Optics’ handheld retinal imaging system
The FDA has granted 510(k) clearance to AI Optics’ Sentinel Camera, a handheld retinal imaging system that captures ...
MassDevice5d
FDA clears AI 3D head, neck imaging tech from RapidAI
RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.
HCW Biologics Granted FDA Clearance to Evaluate One of the Company’s Lead Product Candidates in a First-In-Human Phase 1 Clinical Trial
This study will evaluate HCW9302 in patients with moderate to severe alopecia areataMIRAMAR, Fla., Feb. 03, 2025 (GLOBE ...