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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
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-26
Oct 03, 2024
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-20
Sep 27, 2024
CDMO
FDA Approves First Treatment for Niemann-Pick Disease, Type C
U.S. Food & Drug Administration
PR-09-24-NI-12
Sep 23, 2024
CDMO
UCB Announces FDA Approvals for BIMZELX for Psoriatic Arthritis, Axial Spondyloarthritis, and Ankylosing Spondylitis
UCB
PR-09-24-NI-13
Sep 23, 2024
Cell and Gene Therapy Regulatory
Navigating Regulatory Complexity for Cell and Gene Therapies
Natasha Rivas
PAO-04-24-CL-03
Apr 12, 2024
mRNA–LNP Manufacturing
The Innovators Bringing Continuous Manufacturing to Lipid Nanoparticles
Antonio Costa, Ph.D.; William Pasek
DIANT Pharma
PAO-03-24-CL-08
Mar 18, 2024
Nitrosamine Impurities
Addressing the Evolving Nitrosamine Contamination Issue
Olon
PAO-09-23-CL-07
Sep 15, 2023
Continuous Processing
US Food and Drug Administration (FDA) Purchase the LiFT System from DIANT® Pharma INC.
DIANT Pharma
PR-M07-23-03
Jul 31, 2023
Cultivated Meat
Leveraging Biopharma Sensor Technologies for Cultivated Meat Processes
Giovanni Campolongo
Hamilton
PAO-05-23-CL-02
May 17, 2023
Cosmeceuticals
Cosmeceuticals Are Here. When Will Regulations Catch Up?
Ameena Pathan
That's Nice LLC
PAO-08-022-CL-09
Aug 31, 2022
Column: Regulatory Spotlight
The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative
David Alvaro, Ph.D.
Pharma's Almanac
PAO-06-022--NI-05
Jun 24, 2022
