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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
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
Passion and Understanding Essential for Rare Disease Clinical Trials
Juliet Moritz
Ergomed
PAO-10-24-CL-03
Oct 29, 2024
BIOSECURE Act
Can you discuss the anticipated impacts of the BIOSECURE Act on the biopharmaceutical landscape?
Pharma's Almanac
PAO-11-24-RT-01
Oct 28, 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
Clinical Result
Actinium Pharmaceuticals Announces Publication of Results from the Phase 3 SIERRA Trial of Iomab-B in Clinical Oncology
Actinium Pharmaceuticals, Inc.
PR-09-24-NI-09
Sep 20, 2024
Expansion
Building on a Pioneering Biomanufacturing Legacy with Client Centricity
Benedikt von Braunmühl; Tom Roberts
Rentschler Biopharma SE
PAO-09-24-CL-05
Sep 09, 2024
IND Enablement
IND Enablement and Drug Product Development – Mitigating Risk and Accelerating through the "Valley of Death"
Johannes Clemens
Coriolis Pharma
PAO-08-24-CL-07
Aug 16, 2024
