Regulatory Filings and Submissions

According to Eli Lilly and Company, the extended dosing interval reduces maintenance injections to as few as 6 per year without required topical corticosteroids.

The approval is based on phase 3 non-inferiority data from the IRAKLIA study, making isatuximab the first anticancer therapy administered via an on-body injector in the EU.

The Phase 3 CANOPY-HCH-3 data show statistically significant gains in annualized growth velocity, standing height, and arm span at 52 weeks; regulatory filings planned for Q3 2026.

FDA’s approval of Immgolis and Immgolis Intri introduces the first golimumab biosimilars for rheumatoid arthritis and ulcerative colitis in the United States.

The approval of zenocutuzumab-zbco for NRG1 fusion-positive cholangiocarcinoma expands precision oncology options for patients with rare molecularly defined cancers.

FDA’s extended review of a subcutaneous formulation of lecanemab highlights ongoing regulatory evaluation of alternative anti-amyloid delivery approaches for early Alzheimer’s disease.

Data from a phase 3 study show statistically significant improvements in proptosis and diplopia, along with favorable tolerability, which support regulatory advancement of elegrobart, a subcutaneous IGF-1R–targeting therapy for chronic autoimmune disease.

MRM Health’s MH002 gains FDA fast track, advancing microbiome-based therapy targeting immune modulation in ulcerative colitis patients.

BeOne Medicines’ tislelizumab and zanidatamab show improved survival in HER2+ GEA, highlighting combination immunotherapy advances in gastroesophageal cancer.

Henlius and Organon have secured approval in Europe for its pertuzumab (POHERDY) biosimilar, expanding biosimilar access for HER2-positive breast cancer treatment across oncology settings.

FDA has granted priority review to Johnson & Johnson's nipocalimab for warm autoimmune hemolytic anemia, a rare disorder with no approved US therapies.

CHMP has supported intrathecal onasemnogene abeparvovec, Novartis' gene therapy for 5q SMA in patients aged 2 years and older in the EU.

Savara’s inhaled GM-CSF therapy for autoimmune PAP faces delayed review, potentially postponing access to a treatment targeting impaired lung function

FDA approval of a denosumab (Prolia) biosimilar and dual filing acceptances by FDA and EMA for an omalizumab (Xolair) biosimilar candidate from Teva signal increasing competition in the biosimilar markets as well as expanded access for allergy and immunology patients.

The approval introduces a one-time gene therapy for LAD-I that restores immune function and addresses the underlying cause of a life-threatening pediatric disease.

FDA’s approval of a high-dose nusinersen from Biogen improves SMA treatment durability and supports evolving therapy sequencing strategies in a competitive neuromuscular market.

GSK’s B7-H3-targeted ADC has shown durable responses in SCLC, supporting regulatory momentum and advancing targeted approaches for high-unmet-need lung cancers.

Data from a Phase III trial showed durable survival benefit with PD-L1 blockade plus chemotherapy, reinforcing the use of immunotherapy in curative-intent GI cancer settings.

Regulatory acceptance of tildrakizumab's sBLA signals a potential expansion of IL-23 inhibition into joint disease, an area in which treatment gaps persist for a substantial share of psoriatic disease patients.

Data from the MajesTEC-9 Phase III trial shows teclistamab as monotherapy improves survival, indicating a shift in multiple myeloma treatment.

Phase III trial results show that trastuzumab deruxtecan reduced invasive recurrence or death 53% in patients with residual HER2-positive disease after neoadjuvant therapy.

China’s approval of Sciwind’s ecnoglutide for weight management, alongside the company’s Pfizer commercialization deal, intensifies competition in the global GLP-1 market.

FDA’s priority review designation of Regeneron Pharmaceuticals’ garetosmab underscores Activin A inhibition as a potential disease-modifying strategy for genetically driven ossification disorders.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

FDA’s breakthrough therapy designation for Johnson & Johnson’s co-formulated bispecific antibody therapy validates dual EGFR/MET targeting in HPV-negative head and neck cancer.