FDA’s CRL focused on CMC deficiencies, with no objections to clinical safety or efficacy, enabling a resubmission pathway primarily driven by manufacturing remediation. The NDA was accepted in October ...

All Swiss watch manufactures are not the same. But on the surface, yeah, they pretty much are. A lot of white coats, airlocks, dust suppression mechanisms, highly skilled watchmakers, and inspiring ...

Randomized phase II trial investigating whether atezolizumab after chemoradiotherapy (CRT) prolongs survival in limited stage (LS) small cell lung cancer (SCLC). Perioperative nivolumab (NIVO) vs ...

CTx-1301 is designed to deliver 3 separate releases of medication at different times and in different ratios. Topline data were announced from a phase 3 trial evaluating CTx-1301 for the treatment of ...

Cingulate Inc. submitted CTx-1301 Phase 3 safety data to the FDA, preparing for a Pre-NDA meeting on April 2, 2025. Cingulate Inc. announced the submission of Phase 3 safety data for its ADHD ...

Mirum Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has approved Ctexli (chenodiol) tablets, a bile acid, for the treatment of adults with cerebrotendinous ...

The US Food and Drug Administration (FDA) has approved Mirum Pharmaceuticals’ Ctexli (chenodiol) to treat adults with cerebrotendinous xanthomatosis (CTX). The oral drug is now the first treatment to ...

Mirum Pharma's Ctexli has become the first FDA-approved therapy for cerebrotendinous xanthomatosis (CTX), an ultra-rare form of lipid storage disease. Ctexli (chenodiol) has been cleared to treat ...

Last year, Casio released a collection of rings, each designed to look like one of its most iconic digital watches from the last 50 years. The catch? None of those previous tiny timepieces actually ...

There’s no fitness tracking or heart rate monitoring with Casio’s new wearable. There’s no fitness tracking or heart rate monitoring with Casio’s new wearable. is a senior reporter who’s been covering ...

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No, Casio’s “vintage” watches aren’t actually vintage. They do look the part, though, which is one reason they’re so popular. That, and they’re damn awesome watches that are astonishingly affordable.