FDA Priority Review for Epcoritamab in Refractory Lymphoma
Genmab A/S and AbbVie have received Priority Review from the FDA for epcoritamab-bysp, a bispecific antibody for the treatment...
Jon Napitupulu
Mandara III Data: Fasenra Aids EGPA Remission, NEJM Reports
Positive results from the MANDARA Phase III trial for FASENRA® (benralizumab) in patients with eosinophilic granulomatosis with polyangiitis (EGPA)...
Biktarvy by Gilead: FDA Approval for Resistant HIV Cases
Gilead Sciences, Inc. has announced the FDA’s approval of an expanded indication for Biktarvy® to treat people with HIV...
Merck’s Keytruda Gets Positive CHMP Opinion for NSCLC Therapy
Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive...
Xolair’s NEJM Phase III Data: Hope for Multiple Food Allergies
Genentech announced key findings from Stage 1 of the NIH-sponsored Phase III OUtMATCH study, published in the New England...
Silence Therapeutics Nabs $10M From AstraZeneca Phase 1 Start
Silence Therapeutics plc, a biotechnology company specializing in RNA interference (RNAi) therapies, has announced the initiation of a Phase...
Worldwide Clinical Trials Trials Upgrades Unit Pharmacy for Client Efficiency
Worldwide Clinical Trials has enhanced its Clinical Pharmacology Unit (CPU) in San Antonio, Texas, with a significant expansion completed...
Tagrisso’s Phase III Success in Unresectable EGFR Lung Cancer
AstraZeneca’s TAGRISSO® (osimertinib) has shown positive results in the LAURA Phase III trial, demonstrating a significant and clinically meaningful...
EU Nods Pfizer’s Velsipity® for Ulcerative Colitis
Pfizer Inc. announced that the European Commission has approved VELSIPITY® (etrasimod) for the treatment of patients aged 16 and...
Datopotamab Deruxtecan BLA Accepted for US Lung Cancer
Daiichi Sankyo and AstraZeneca’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the U.S. FDA...