FDA

1 / 25
Inclusive Trials Are Better Trials: Why Women’s Health Can’t Be a Footnote Anymore
Inclusive Trials

Inclusive Trials Are Better Trials: Why Women’s Health Can’t Be a Footnote Anymore

Emilee Kudla

Pharma's Almanac

PAO-05-25-NI-13May 30, 2025
Half the Data, Half the Science: The Cost of Ignoring Sex Differences in Preclinical Research
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-05May 15, 2025
Understanding the Drug Supply Chain Security Act
DSCSA

Understanding the Drug Supply Chain Security Act

Leandro Moreira

Frontier Scientific Solutions

PAO-04-25-CL-05May 08, 2025
What’s Really in Your Rainbow Cereal? The Truth About Synthetic Food Dyes and Why They’re (Finally) Getting the Boot
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

Pharma's Almanac

PAO-04-25-NI-12Apr 23, 2025
The End of an Era: What the FDA's Move Away from Animal Testing Means for Biopharma
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-06Apr 14, 2025
Is mRNA a Gene Therapy? Unpacking the Evolving Regulatory Debate
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-06Mar 26, 2025
30 Years of Accelerated Approvals: Fast-Tracking Innovation in Drug Development
Accelerated Approval

30 Years of Accelerated Approvals: Fast-Tracking Innovation in Drug Development

Cynthia A. Challener, Ph.D.

Pharma's Almanac

PAO-25-30-07Mar 02, 2025
From Market Failures to Lifesaving Innovations: The Evolution of Orphan Drugs
Orphan Drugs

From Market Failures to Lifesaving Innovations: The Evolution of Orphan Drugs

Cynthia A. Challener, Ph.D.

Pharma's Almanac

PAO-25-30-06Mar 02, 2025
Science Under Siege: The Devastating Consequences of Public Health and Research Cuts
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-04Feb 19, 2025
Sano Chemicals Inc
Announcement

Sano Chemicals Inc Announces Approval to Start Phase 1 MAD Study

Sano Chemicals Inc

PR-01-25-NI-30Feb 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-25Jan 24, 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
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-81Nov 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-70Nov 01, 2024
Designing Quality into Biomanufacturing
QbD

Designing Quality into Biomanufacturing

Miguel Carrion; Michelle Kneeland

Tanvex CDMO

PAO-10-24-CL-09Oct 29, 2024
Novavax
Clinical Trials

Update on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial

Novavax

PR-10-24-NI-48Oct 17, 2024
U.S. Food & Drug Administration
FDA

U.S. Food and Drug Administration

U.S. Food & Drug Administration

PR-10-24-NI-44Oct 14, 2024
Accord Biopharma
FDA

FDA Approves IMULDOSA, Accord BioPharma's Biosimilar to STELARA, for the Treatment of Chronic Inflammatory Conditions

Accord Biopharma

PR-10-24-NI-43Oct 14, 2024
Systimmune, Inc.
FDA

SystImmune, Inc. Announces FDA Clearance of IND Application for BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia

Systimmune, Inc.

PR-10-24-NI-42Oct 14, 2024
StemCyte
Clinical Trials

StemCyte's HPC Cord Blood Receives RMAT Designation for Long COVID-19 Treatment

StemCyte

PR-09-24-NI-28Oct 07, 2024
1 / 25