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Regulatory Approval

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How can the industry balance the need for faster drug approvals with the necessity of ensuring patient safety and efficacy?
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
Axcynsis Therapeutics
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
Building a Regulatory Roadmap for IND, NDA, and BLA
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
Many First-in-Class Drugs Approved by FDA in 2022, but Overall Approval Numbers Down
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
The Opportunities and Challenges Posed by Biosimilar Interchangeability
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: Regulatory Approval Brings siRNA into the Rare Disease Toolbox
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
Janssen Pharmaceutical Companies
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
Fast Approval for Roche Drug Alecensa in China
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
China to Accelerate Review of 48 Foreign Drugs
Regulatory

China to Accelerate Review of 48 Foreign Drugs

Cynthia A. Challener, Ph.D.

Pharma's Almanac

PAO-M08-18-NI-013Aug 14, 2018
Amgen
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

EU Approves AstraZeneca’s Respiratory Biologic

Nigel Walker

Nice Insight

PAO-M01-18-NI-031Jan 18, 2018
Abbott
Innovation

New FDA MR-Conditional Labeling Approvals Further Expand Abbott's Portfolio of MRI-Ready Devices

Abbott

PR-M01-18-NI-008Jan 03, 2018
Mitochondrial Expert Mitobridge Snapped Up by Astellas Pharma
Strategic Partnership

Mitochondrial Expert Mitobridge Snapped Up by Astellas Pharma

Nice Insight

PAO-M01-18-NI-002Jan 02, 2018
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