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Drug Approvals

🇺🇸 FDA Page 12

FDA news and analysis for pharmaceutical BD, investment, and market access · 12 articles on this page

Track global drug approvals & regulatory decisions. Gain critical intelligence on new therapies, market access, and competitive landscapes for pharma BD.

Showing 133–144 of 665 articles

High impact NewsJun 3, 2026

FDA Issues Final Guidance for Pulmonary Tuberculosis Drug Development

FDA · pulmonary tuberculosis · 5 min

Dr. Sarah Mitchell
High impact AnalysisJun 3, 2026

Biosimilars Drive Significant Reductions in Specialty Drug Spending

9 min

Dr. Sarah Mitchell
High impact AnalysisJun 3, 2026

ALX Oncology to Present at 2026 Jefferies Global Healthcare Conference, Highlighting Oncology Pipeline

oncology · 6 min

Dr. Sarah Mitchell
High impact AnalysisJun 3, 2026

Legend Biotech's In Vivo CAR-T Data Sparks Stock Surge: A Catalyst Tracking Analysis

8 min

Dr. Sarah Mitchell
High impact AnalysisJun 3, 2026

Advancing Bladder Cancer Care Through Education and Awareness

FDA · bladder cancer · 6 min

Dr. Sarah Mitchell
High impact AnalysisJun 2, 2026

ASCO ‘26: Bispecifics, ADCs, and the RAS Revolution Reshape Oncology

prostate cancer · 7 min

Dr. Sarah Mitchell
High impact AnalysisJun 2, 2026

This Week’s Biopharma News: New Approvals, Appeals, and AI

FDA · 10 min

Dr. Sarah Mitchell
High impact AnalysisJun 2, 2026

Tissue TMB Superior to Blood TMB in Predicting Immunotherapy Response, Cleveland Clinic Study Finds

Tumor Mutation Burden · 7 min

Dr. Sarah Mitchell
High impact AnalysisJun 2, 2026

Celcuity's Gedatolisib: Navigating the Path to Broad FDA Approval in Breast Cancer

FDA · breast cancer · 8 min

Dr. Sarah Mitchell
High impact AnalysisJun 2, 2026

FDA Delays Decision on AstraZeneca's Camizestrant Following Negative Adcomm Vote

FDA · breast cancer · 9 min

Dr. Sarah Mitchell
Critical impact AnalysisJun 2, 2026

FDA Declines Cingulate's ADHD Drug CTx-1301 Over Manufacturing Concerns

FDA · ADHD · 9 min

Dr. Sarah Mitchell
High impact AnalysisJun 2, 2026

ASCO 2026 Preview: Key Data and Trends in Cancer Research

pancreatic cancer · 7 min

Dr. Sarah Mitchell