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RNA
Is mRNA a Gene Therapy? Unpacking the Evolving Regulatory Debate
Cynthia A. Challener, Ph.D.; April Stanley, MS MBA
Pharma's Almanac
PAO-03-25-NI-06
Mar 26, 2025
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-01
Mar 26, 2025
Global Trials
Clinical Trials Without Borders: The Evolution of Global Drug Development
David Alvaro, Ph.D.
Pharma's Almanac
PAO-25-30-21
Mar 14, 2025
Advocacy
From Patients to Partners: The Rising Power of Advocacy in Drug Development
David Alvaro, Ph.D.
Pharma's Almanac
PAO-25-30-19
Mar 13, 2025
Accelerated Approval
30 Years of Accelerated Approvals: Fast-Tracking Innovation in Drug Development
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-25-30-07
Mar 02, 2025
Orphan Drugs
From Market Failures to Lifesaving Innovations: The Evolution of Orphan Drugs
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-25-30-06
Mar 02, 2025
Boehringer Ingelheim Pharmaceuticals, Inc.
FDA
Boehringer's Zongertinib ReceivesFDA Priority Review for the Treatment of HER2 (ERBB2)- NSCLC
Boehringer Ingelheim Pharmaceuticals, Inc.
PR-02-25-NI-21
Feb 20, 2025
Anixa Biosciences
Approval
Anixa Biosciences Announces Approval of Protocol Amendment for Ovarian Cancer CAR-T Clinical Trial
Anixa Biosciences
PR-02-25-NI-16
Feb 19, 2025
Federal Job Cuts
Science Under Siege: The Devastating Consequences of Public Health and Research Cuts
David Alvaro, Ph.D.
Pharma's Almanac
PAO-02-25-NI-04
Feb 19, 2025
Roche
FDA
Roche Receives FDA 510(k) Clearance for the First Blood Test in the U.S. Measuring Lp(a) in Nolar Units
Roche
PR-01-25-NI-29
Feb 11, 2025
Nektar Therapeutics
Drug Development
Nektar Therapeutics Receives Fast Track Designation for the Treatment of Moderate-to-Severe Atopic Dermatitis
Nektar Therapeutics
PR-02-25-NI-07
Feb 10, 2025
Sano Chemicals Inc
Announcement
Sano Chemicals Inc Announces Approval to Start Phase 1 MAD Study
Sano Chemicals Inc
PR-01-25-NI-30
Feb 04, 2025
Clarity
FDA
Clarity Receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in Biochemical Recurrence of Prostate Cancer
Clarity
PR-01-25-NI-25
Jan 24, 2025
Axcynsis Therapeutics
FDA
Axcynsis Therapeutics Receives FDA Clearance for IND Application of AT03-65 Powered by AxcynDOTâ„¢ Technology
Axcynsis Therapeutics
PR-01-25-NI-19
Jan 16, 2025
Oncolytics Biotech
Clinical CRO
Regulatory Approval Clears Path for Oncolytics Biotech to Pancreatic Cancer Treatment
Oncolytics Biotech
PR-01-25-NI-18
Jan 16, 2025
Large Molecule
Managing Pharmacovigilance Challenges for Biosimilars
Ivana Lisec, MPharm
PrimeVigilance
PAO-11-24-CL-05
Jan 02, 2025
AI
AI Implementation to Enhance Quality
Seongil Cho; Hyeokgeon Kwon; Kisung Shim
Samsung Biologics
PAO-12-24-CL-5
Dec 13, 2024
HuidaGene Therapeutics
FDA
HuidaGene Therapeutics Receives the First-Ever FDA Clearance of CRISPR/Cas13 RNA-Editing HG202 for Macular Degeneration
HuidaGene Therapeutics
PR-10-24-NI-81
Nov 07, 2024
Eisai
Clinical Treatment
Eisai Completes Submission to US FDA for LEQEMBI Application for Maintenance Dosing for the Treatment of Early Alzheimer's Disease
Eisai
PR-10-24-NI-70
Nov 01, 2024
QbD
Designing Quality into Biomanufacturing
Miguel Carrion; Michelle Kneeland
Tanvex CDMO
PAO-10-24-CL-09
Oct 29, 2024
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