Why Aurora Therapeutics believes the FDA is ready for grouped CRISPR approvals
Can Aurora Therapeutics make CRISPR work at scale? Find out how its platform model for rare disease editing is testing biotech’s next big leap.
Pharma & Biotech
Pharma & Biotech
Can zetomipzomib move the needle in autoimmune hepatitis? What Kezar’s FDA meeting signals
Kezar is seeking FDA alignment for zetomipzomib in autoimmune hepatitis. Find out what’s at stake for trial design, safety, and strategic alternatives.
Pharma & Biotech
Incyte’s tafasitamab clears pivotal trial in high-risk DLBCL—will it shift front-line treatment?
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
Pharma & Biotech
FDA maintains constructive stance as Island Pharmaceuticals progresses Galidesivir clinical development
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
Pharma & Biotech
Diamyd Medical fast-tracks type 1 diabetes Phase 3 trial after FDA alignment on earlier efficacy readout
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.
Pharma & Biotech
AstraZeneca, Daiichi Sankyo push Enhertu into early breast cancer with new FDA nod
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
Pharma & Biotech
FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers
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
Pharma & Biotech
Milestone Pharmaceuticals’ CARDAMYST nasal spray wins FDA approval: A new chapter for self-administered PSVT treatment
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.
Pharma & Biotech
Gonorrhea resistance crisis: Can Innoviva’s zoliflodacin rewrite treatment guidelines?
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
Pharma & Biotech
Will IFx-2.0 and TBS-2025 push TuHURA into the frontline of resistance-focused oncology?
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