AbbVie’s RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis
Adult GCA can now be treated with RINVOQ (upadacitinib), the first and only oral Janus Kinase (JAK) inhibitor authorized for this purpose.
Category: Regulatory
Roche granted FDA breakthrough device designation for VENTANA TROP2, an AI-driven companion diagnostic for non-small cell lung cancer
The gadget analyzes images using artificial intelligence to achieve a degree of diagnosis accuracy that is not achievable with conventional manual grading techniques.
AbbVie Submits Biologics License Application (BLA) to U.S. FDA for TrenibotulinumtoxinE (TrenibotE), Treating Glabellar Lines
AbbVie declared that they had submitted the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE) to the United States FDA for the treatment of moderate to severe glabellar lines. [Read More…]
European Commission Approves Roche’s Columvi® (glofitamab) For B-cell Lymphoma Based on the Phase III STARGLO Study Results
Columvi therapy provides a much-needed, off-the-shelf, fixed-duration alternative for transplant ineligible individuals.
Dupixent (Dupilumab), Sanofi’s New Targeted Therapy For Chronic Spontaneous Urticaria Approved by the U.S. FDA
Phase 3 tests showing Dupixent dramatically decreased itching and hives when compared to a placebo led to approval.
European Union Grants Marketing Approval for Biogen’s Leqembi® an Amyloid-beta (Aβ) Monoclonal Antibody
Lecanemab is the only approved Aβ monoclonal antibody that binds and clears hazardous protofibrils.
U.S. FDA to Phase Out Animal Testing for the Development of Monoclonal Antibodies and Other Drugs
The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.
U.S. FDA Approved Amgen’s UPLIZNA® (INEBILIZUMAB-CDON) for the Treatment of Rare Immune Disorder
IgG4-RD can arise in various organs, causing fibrosis and irreversible organ damage. Understanding how organ damage occurs is key to making an accurate diagnosis of IgG4-RD.
Aldeyra Therapeutics Responds to the U.S. FDA’s Denial of Reproxalap’s NDA Application for Treating Signs and Symptoms of Dry Eye Disease
FDA stated in the letter that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes”.
Pfizer’s RSV Lower Respiratory Tract Disease Vaccine ABRYSVO®Approved by European Commission
Pfizer Inc (PFI). announced that the European Commission (EC) has amended the marketing authorization for ABRYSVO®, the company’s bivalent respiratory syncytial virus (RSV) prefusion F [Read More…]
