Incyte Corporation has announced positive topline results from its Phase 3 frontMIND trial evaluating tafasitamab (marketed as Monjuvi/Minjuvi) and lenalidomide in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint of progression-free survival (PFS) and a key secondary endpoint of event-free survival (EFS), setting the stage for […]
Island Pharmaceuticals Limited has confirmed that the United States Food and Drug Administration (FDA) continues to evaluate its most recent regulatory submission related to Galidesivir, the company’s clinical-stage antiviral candidate being advanced under the Animal Rule pathway. In correspondence dated 2 January 2026, the regulator informed the Australian biotech firm that additional time is required […]
Find out how Diamyd Medical is accelerating its type 1 diabetes Phase 3 trial after FDA alignment—what this means for approval, adoption, and risk.
AstraZeneca PLC and Daiichi Sankyo’s HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for use in patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment and are at high risk of recurrence. The designation is based on positive results […]
The U.S. Food and Drug Administration has approved Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), the first subcutaneous version of its bispecific EGFR-MET antibody therapy, for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval spans all current RYBREVANT indications and is based on the Phase 3 PALOMA-3 study, which demonstrated comparable pharmacokinetics […]
Milestone Pharmaceuticals’ CARDAMYST FDA approval marks a new era in PSVT care. Find out how this first‑in‑class nasal treatment could transform acute arrhythmia management.
Innoviva Specialty Therapeutics has reported publication of pivotal Phase 3 data in The Lancet showing that its investigational oral antibiotic zoliflodacin was non-inferior to the current standard-of-care dual therapy for uncomplicated urogenital gonorrhea. The study, conducted in partnership with the Global Antibiotic Research & Development Partnership, or GARDP, compared a single oral dose of zoliflodacin […]
TuHURA Biosciences, Inc. has announced a comprehensive corporate update that includes progress across three of its major immuno-oncology programs. The update covers the company’s lead asset IFx-2.0, currently in a Phase 3 trial in combination with pembrolizumab for advanced Merkel cell carcinoma; the next-stage development of TBS-2025, a VISTA-blocking monoclonal antibody being advanced for relapsed […]
Atossa Therapeutics has received Rare Pediatric Disease (RPD) designation from the U.S. Food and Drug Administration for (Z)-Endoxifen in Duchenne muscular dystrophy (DMD), a strategic shift that positions the estrogen receptor modulator for possible use in pediatric neuromuscular disorders. If approved, the program could qualify for a transferable Priority Review Voucher, but the timeline and […]
KVP International has announced the acquisition of SafePath Laboratories and IVD Research, a diagnostics manufacturer and contract development and manufacturing organization (CDMO) provider headquartered in Carlsbad, California. With this move, KVP International aims to strengthen its footprint in veterinary diagnostics while unlocking the potential to expand into human health markets. This acquisition provides KVP International […]