Portal Diabetes has received Breakthrough Device Designation by the Food and Drug Administration (FDA) for its implantable ...

Today, Portal Diabetes, Inc. ("Portal") announced its receipt of the Breakthrough Device Designation by the Food and Drug Administration (FDA) for its implantable insulin pump system called "Portal ...

The FDA's regulatory change enables no artificial colours labelling claims and expands natural colour approvals, supporting ...

PBGENE-DMD is Precision's wholly-owned, first-in-class in vivo gene editing program utilizing a gene excision approach intended to permanently correct the dystrophin gene in patients with mutations ...

Maharashtra FDA appoints 34 lab personnel for its Mumbai based drug testing lab: Shardul Nautiyal, Mumbai Monday, February 16, 2026, 08:00 Hrs [IST] As part of strengthening of ma ...

A milestone in the treatment of Duchenne muscular dystrophy (DMD) passed recently with remarkably little public notice. That ...

Encora's device is set to be available in the US via a prescription-only model.

REGENXBIO Inc. RGNX shares are lower during Tuesday's premarket session as the company faces challenges following a recent Complete Response Letter (CRL) from the U.S. Food and Drug Administration ...

Agency Feedback Provides Regulatory Clarity on Enrichment Strategy and Confirms CDR-SB as Sole Primary Endpoint for ...

A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi. | A ...

Showcase EXOMIND GRAND RAPIDS, Mich., Feb. 3, 2026 /PRNewswire/ -- Freedom Functional Medicine is ringing in the New Year by offering the latest noninvasive device to optimize mental health. EXOMIND, ...

CTK recently completed FDA OTC registration and related compliance steps for three white-label suncare products: a sun lotion, sun stick, and sun serum. “OTC” refers to drug products that can be ...