Approved
AbbVie Advances Solid Tumor Program with FDA Approval of Emrelis for Lung Cancer
AbbVie; Emrelis; FDA Approval; ADC; solid tumor; lung cancer; non-small cell lung cancer; c-Met overexpression; telisotuzumab vedotin-tllv; accelerated approval
Argenx brews up DTC push for Vyvgart Hytrulo prefilled syringe in generalized myasthenia gravis
Vyvgart Hytrulo, prefilled syringe, FDA approval, self-administration, generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), DTC campaign, patient empowerment
RFK Jr. claims placebo-controlled vaccine trials are’radical departure’ from past. Experts disagree
Vaccines, placebo-controlled trials, CHARGE Syndrome, experts, Effectiveness, RFK Jr., Policy, Approved, HHS
Aldeyra hopes new data for dry-eye disease drug will satisfy FDA
United States Food and Drug Administration, Aldeyra, reproxalap, Approved, Dry Eye Syndromes, Clinical Trials, New Drug Application
PTC crashes as win for Novartis-partnered Huntington’s drug fails to convince investors
factor IX, PTC518, Accelerated, Approved, United States Food and Drug Administration
FDA Approves Johnson & Johnson’s Imaavy: A New Treatment Option for Generalized Myasthenia Gravis
Imaavy, nipocalimab-aahu, FcRn blocker, generalized myasthenia gravis (gMG), FDA approval, Johnson & Johnson, autoimmune disease, IgG reduction
FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts
United States Food and Drug Administration, PDUFA, Impact food supplement, Approved, Agencies, questions
AbbVie’s Rinvoq cleared for giant cell arteritis in US
Giant Cell Arteritis, Rinvoq, upadacitinib, Approved, Janus kinase, Inhibitor, United States Food and Drug Administration, Steroids
Abeona’s $3.1M gene therapy wins FDA nod for rare skin disease
United States Food and Drug Administration, United States Food and Drug Administration, Infrequent, ZEVASKYN, Abeona, gene therapy, Dermatologic disorders, Hallopeau-Siemens Disease, Approved, Abeona ‘s
FDA approves Abeonas skin disease cell therapy
ZEVASKYN, United States Food and Drug Administration, Hallopeau-Siemens Disease, Approved, Wounds – qualifier, gene therapy, Abeona, Treating