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Sex Differences
Half the Data, Half the Science: The Cost of Ignoring Sex Differences in Preclinical Research
David Alvaro, Ph.D.
Pharma's Almanac
PAO-05-25-NI-05
May 15, 2025
DSCSA
Understanding the Drug Supply Chain Security Act
Leandro Moreira
Frontier Scientific Solutions
PAO-04-25-CL-05
May 08, 2025
Food Dyes
What’s Really in Your Rainbow Cereal? The Truth About Synthetic Food Dyes and Why They’re (Finally) Getting the Boot
Emilee Kudla
That's Nice LLC
PAO-04-25-NI-12
Apr 23, 2025
Animal Testing
The End of an Era: What the FDA's Move Away from Animal Testing Means for Biopharma
Daniel Smith, Ph.D.
Nice Consulting
PAO-04-25-NI-06
Apr 14, 2025
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
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
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
Announcement
Sano Chemicals Inc Announces Approval to Start Phase 1 MAD Study
Sano Chemicals Inc
PR-01-25-NI-30
Feb 04, 2025
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
FDA
Axcynsis Therapeutics Receives FDA Clearance for IND Application of AT03-65 Powered by AxcynDOT™ Technology
Axcynsis Therapeutics
PR-01-25-NI-19
Jan 16, 2025
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
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
Clinical Trials
Update on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial
Novavax
PR-10-24-NI-48
Oct 17, 2024
FDA
U.S. Food and Drug Administration
U.S. Food & Drug Administration
PR-10-24-NI-44
Oct 14, 2024
FDA
FDA Approves IMULDOSA, Accord BioPharma's Biosimilar to STELARA, for the Treatment of Chronic Inflammatory Conditions
Accord Biopharma
PR-10-24-NI-43
Oct 14, 2024
FDA
SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia
Systimmune, Inc.
PR-10-24-NI-42
Oct 14, 2024
Clinical Trials
StemCyte's HPC Cord Blood Receives RMAT Designation for Long COVID-19 Treatment
StemCyte
PR-09-24-NI-28
Oct 07, 2024
FDA
Thryv Therapeutics Granted FDA Orphan Drug Designation for LQT-1213 in Long QT Syndrome Treatment
Thryv Therapeutics Inc
PR-09-24-NI-27
Oct 03, 2024
