FDA News

Experimental IgG4-RD Drug Submission to FDA After Successful Trial

FDA · IgG4-RD · 2 min

FDA PreCheck Pilot Program Launches: A New Era for Clinical Trials

FDA · 4 min

FDA Loosens Regulations on Digital Health Tools

FDA · 2 min

US FDA Extends Decision Date for Camizestrant Filing

FDA · oncology · 2 min

FDA Delays Decision on AstraZeneca Breast Cancer Pill: What It Means

FDA · breast cancer · 2 min

Lifesaving Upgrades: 40 Years of FDA Oncology Approvals

FDA · oncology · 3 min

FDA Guidelines Enhance Generic Bioequivalence in Oncology Drugs

FDA · oncology · 2 min

FDA Calendar 2026: Key Approval Dates and PDUFA Insights

FDA · 2 min

FDA Restricts Large-Scale Compounding of Weight Loss Drugs

FDA · weight loss · 2 min

FDA Clarifies 3-Year Exclusivity Guidance: Key Insights

FDA · 2 min

Industry Groups Push for FDA Guidance Changes on Form 483 Responses

FDA · 2 min

Potential FDA Approval for Eye Drug: What It Means for Pharma

FDA · 3 min