Drug Approvals
How can the industry balance the need for faster drug approvals with the necessity of ensuring patient safety and efficacy?
Pharma's Almanac
PAO-03-25-RT-01Mar 26, 2025
FDA
Axcynsis Therapeutics Receives FDA Clearance for IND Application of AT03-65 Powered by AxcynDOT™ Technology
Axcynsis Therapeutics
PR-01-25-NI-19Jan 16, 2025
IND, NDA, and BLA
Building a Regulatory Roadmap for IND, NDA, and BLA
Rebecca Lamb-Wharton, Ph.D.; Brenda Schlenk, RPh; Mamadou Diallo, PharmD
PAO-03-24-CL-10Mar 26, 2024
FDA New Drug Approvals
Many First-in-Class Drugs Approved by FDA in 2022, but Overall Approval Numbers Down
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-03-23-NI-03Mar 07, 2023
Interchangeable Biosimilars
The Opportunities and Challenges Posed by Biosimilar Interchangeability
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-03-23-NI-01Mar 07, 2023
New Drug News
New Drug News: Regulatory Approval Brings siRNA into the Rare Disease Toolbox
David Alvaro, Ph.D.
Pharma's Almanac
PAP-Q4-18-NI-010Oct 26, 2018
Regulatory
Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX® (daratumumab) Split Dosing Regimen
Janssen Pharmaceutical Companies
PR-M08-18-NI-093Aug 23, 2018
Drug Approval
Fast Approval for Roche Drug Alecensa in China
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-M08-18-NI-023Aug 22, 2018
Regulatory
China to Accelerate Review of 48 Foreign Drugs
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-M08-18-NI-013Aug 14, 2018
Biosimilar
European Commission Approves Amgen And Allergan's MVASI® (Biosimilar Bevacizumab) For The Treatment Of Certain Types Of Cancer
Amgen
PR-M01-18-NI-077Jan 24, 2018
EU Approves AstraZeneca’s Respiratory Biologic
Nigel Walker
Nice Insight
PAO-M01-18-NI-031Jan 18, 2018
Innovation
New FDA MR-Conditional Labeling Approvals Further Expand Abbott's Portfolio of MRI-Ready Devices
Abbott
PR-M01-18-NI-008Jan 03, 2018
Strategic Partnership
Mitochondrial Expert Mitobridge Snapped Up by Astellas Pharma
Nice Insight
PAO-M01-18-NI-002Jan 02, 2018