The American Journal of Managed Care

FDA Issues Complete Response Letter for Cingulate's Once-Daily ADHD Drug CTx-1301

FDA feedback centered on CMC documentation and quality/manufacturing controls, a common first-cycle barrier that typically does not necessitate additional efficacy or safety trials. Pediatric ...
Pharm Exec

FDA Sends CRL to Cingulate for CTx-1301

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 ...
Investopedia

HTML Basics: Understanding HyperText Markup Language

Adam Hayes, Ph.D., CFA, is a financial writer with 15+ years Wall Street experience as a derivatives trader. Besides his extensive derivative trading expertise, Adam is an expert in economics and ...
Business Wire

Centauri Therapeutics Granted FDA QIDP Status for CTX-187 Treatment of Gram-Negative Bacterial Infections

ALDERLEY PARK, England--(BUSINESS WIRE)--Centauri Therapeutics Limited (‘Centauri’ or ‘the Company’), an immunotherapy company with a unique and proprietary platform technology applicable across a ...
GitHub

2d.drawImage.zerosource.html

assert_throws("INDEX_SIZE_ERR", function() { ctx.drawImage(response, 10, 10, 0, 1, 0, 0, 100, 50); }); assert_throws("INDEX_SIZE_ERR", function() { ctx.drawImage ...
Nasdaq

Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control

Once-daily formulation of dexmethylphenidate achieved primary endpoint (p 0.001) with consistent symptom relief up to 12 hours post-dose KANSAS CITY, Kan., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Cingulate ...
Nasdaq

Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301

KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform ...
Yahoo Finance

New Rapid Test to Detect CTX-M Enzymes Now FDA-cleared

SANTA MARIA, Calif., July 29, 2025 /PRNewswire/ -- Hardy Diagnostics is pleased to announce the FDA clearance of the NG-TEST® CTX-M Multi, an in vitro, rapid, and visual immunoassay for the ...
ascopubs.org

Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304.

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 ...
PMLiVE

FDA approves Mirum’s Ctexli as first treatment for rare lipid storage disease CTX

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 ...
pharmaphorum

FDA clears first therapy for rare disease CTX from Mirum

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 ...
The Business Journals

Deal pays off for drugmaker with approval for rare cholesterol-related disease treatment

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min The drug was central to a $445 ...