Drug Approvals
How can the industry balance the need for faster drug approvals with the necessity of ensuring patient safety and efficacy?
Pharma's Almanac
PAO-03-25-RT-01Mar 26, 2025
FDA
Boehringer's Zongertinib ReceivesFDA Priority Review for the Treatment of HER2 (ERBB2)- NSCLC
Boehringer Ingelheim Pharmaceuticals, Inc.
PR-02-25-NI-21Feb 20, 2025
FDA
Roche Receives FDA 510(k) Clearance for the First Blood Test in the U.S. Measuring Lp(a) in Nolar Units
Roche
PR-01-25-NI-29Feb 11, 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-25Jan 24, 2025
CDMO
UCB Announces FDA Approvals for BIMZELX for Psoriatic Arthritis, Axial Spondyloarthritis, and Ankylosing Spondylitis
UCB
PR-09-24-NI-13Sep 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-09Sep 20, 2024
Expansion
Building on a Pioneering Biomanufacturing Legacy with Client Centricity
Benedikt von Braunmühl; Tom Roberts
Rentschler Biopharma SE
PAO-09-24-CL-05Sep 09, 2024
FDA Approval
Possible New Hope for Metastatic Cancer Patients: Food and Drug Administration Grants Approval for Clinical Trials For Lamassu's Groundbreaking Cancer Treatment Protocol
Lamassu Biotech
PR-M04-24-01Apr 19, 2024
FDA New Drug Approvals
Many First-in-Class Drugs Approved by FDA in 2022, but Overall Approval Numbers Down
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-03-23-NI-03Mar 07, 2023
Column: Clinical Trials
CAR-T Study Shines New Spotlight on Clinical Trials Representation
David Alvaro, Ph.D.
Pharma's Almanac
PAO-06-022--NI-06Jul 02, 2022
Column: New Drug Watch
New Drug Watch: A Validation of the ‘Twincretin’ Approach to Type 2 Diabetes
David Alvaro, Ph.D.
Pharma's Almanac
PAO-06-022--NI-08Jun 24, 2022
Column: New Drug Watch
Alzheimer Drug Still Controversial
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-03-022-NI-04Mar 23, 2022
COVID-19 Vaccine
FDA Approves SPIKEVAX®, Moderna's mRNA COVID-19 Vaccine
Brand Institute
PR-M02-22-01Feb 01, 2022
FDA Approval
FDA Grants Accelerated Approval for Aduhelm™ as the First and Only Alzheimer’s Disease Treatment to Address a Defining Pathology of the Disease
Biogen
PR-M06-21-015Jun 08, 2021
FDA Approval
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis
Bristol-Myers Squibb
PR-M06-21-008Jun 07, 2021
FDA Approval
Novartis Cosentyx Receives FDA Approval for Treatment of Children and Adolescents with Moderate to Severe Plaque Psoriasis
Novartis
PR-M06-21-002Jun 01, 2021
FDA Approval
Blueprint Medicines Announces FDA Approval of GAVRETO™ (pralsetinib) for the Treatment of Patients with Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancer
Blueprint Medicines
PR-M11-20-027Dec 02, 2020
Antibodies
Lilly's Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19
Eli Lilly and Company
PR-M11-20-023Dec 01, 2020
FDA Approval
FDA Approves First Treatment for Ebola Virus
U.S. Food & Drug Administration
PR-M10-20-10Oct 15, 2020
Opioid
Trevena Announces FDA Approval of OLINVYK Injection
Trevena
PR-M08-20-NI-30Aug 18, 2020