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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
Thryv Therapeutics Inc
FDA

Thryv Therapeutics Granted FDA Orphan Drug Designation for LQT-1213 in Long QT Syndrome Treatment

Thryv Therapeutics Inc

PR-09-24-NI-27Oct 03, 2024
PTC Therapeutics, Inc.
FDA

PTC Therapeutics Announces FDA Acceptance for Filing of NDA for the Treatment of Pediatric and Adult Phenylketonuria Patients

PTC Therapeutics, Inc.

PR-09-24-NI-26Oct 03, 2024
Johnson & Johnson
Clinical Trails

TALVEY and TECVAYLI suggests high response rates in triple-class refractory patients with relapsed or refractory multiple myeloma

Johnson & Johnson

PR-09-24-NI-20Sep 27, 2024
U.S. Food & Drug Administration
CDMO

FDA Approves First Treatment for Niemann-Pick Disease, Type C

U.S. Food & Drug Administration

PR-09-24-NI-12Sep 23, 2024
UCB
CDMO

UCB Announces FDA Approvals for BIMZELX for Psoriatic Arthritis, Axial Spondyloarthritis, and Ankylosing Spondylitis

UCB

PR-09-24-NI-13Sep 23, 2024
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