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FDA Issues Updated Guidance on Food-Effect Studies for IND and NDA Submissions
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Shaily Engineering Gains Tri-Jurisdiction Approval for ShailyPen Neo Autoinjector Device Technology

Pharma Now Editorial Team

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FDA Issues Updated Guidance on Food-Effect Studies for IND and NDA Submissions

FDA's CDER revises food-effect study guidance for IND/NDA submissions, splitting the 2002 document across three pathway-specific instruments.

Pharma Now Editorial Team

Pharma Now

Shaily Engineering Gains Tri-Jurisdiction Approval for ShailyPen Neo Autoinjector Device Technology

Shaily Engineering secures USFDA tentative approval, Health Canada NOC, and Indian clearance for ShailyPen Neo autoinjector in a single development cycle.

Pharma Now Editorial Team

Pharma Now

Phathom Pharmaceuticals Presents 31 Vonoprazan Abstracts at DDW 2026 Across Key GI Indications

Phathom Pharmaceuticals presented 31 vonoprazan abstracts at DDW 2026, including 28 independent studies spanning GERD, H. pylori, and long-term safety.

Pharma Now Editorial Team

Pharma Now

Madrigal Presents Rezdiffra Phase 3 and Real-World Data at EASL 2026 Across Eight Abstracts

Madrigal presents eight Rezdiffra abstracts at EASL 2026, covering CV risk, portal hypertension, and real-world effectiveness data.

Pharma Now Editorial Team

Pharma Now