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
When Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration had approved UPLIZNA (inebilizumab-cdon) for adults with generalized myasthenia gravis (gMG), the industry’s attention snapped not just to the therapy’s mechanism but to its twice-yearly maintenance schedule. For patients, this marks a seismic shift away from the exhausting cycle of daily oral immunosuppressants
The European Commission’s recent approval of €47 million in German state aid for Vetter Pharma’s new aseptic filling facility in Saarlouis marks more than a regional win. It signals a structural shift in how Europe views contract manufacturing organizations, or CDMOs—not merely as outsourcing vendors, but as core pillars of supply chain resilience, regional economic
Vesalio has received 510(k) clearance from the U.S. Food and Drug Administration for enVast, its stent-based coronary clot retrieval system, making it the first device of its kind approved for mechanical thrombectomy in the cardiac circulation. The approval authorizes enVast for U.S. commercialization, following prior regulatory clearance and use in European markets. The device is
Xtant Medical Holdings, Inc. has launched its next-generation synthetic bone graft, nanOss Strata, in the United States. The graft, built from hydroxycarbonapatite (HCA), is designed to enhance bioactivity and integration in orthopedic and spinal surgeries. This launch follows the company’s strategic exit from non-core spinal implant assets, signaling a renewed focus on its biologics portfolio.
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
Allegria Therapeutics has secured USD 5.1 million in a seed extension financing round led by ALK-Abelló, with additional participation from HighLight Capital, the Lichtsteiner Foundation, and existing backer Forty51 Ventures. The Swiss biotechnology company will use the funds to nominate its first clinical candidate and advance its portfolio of mast cell-modulating therapies for allergy and
TransCode Therapeutics, Inc. and Quantum Leap Healthcare Collaborative have launched a Phase 2a dose-expansion trial of TTX-MC138, an RNA-targeting therapeutic aimed at preventing metastatic recurrence in colorectal cancer patients who are ctDNA-positive after standard curative treatment. The trial is part of the PRE-I-SPY platform and will enroll up to 45 patients in early 2026, led
Sen-Jam Pharmaceutical has disclosed a significant equity-based agreement with TASK Clinical, under which the global contract research organization will fund two-thirds of the Phase 3 trial for SJP-001. The candidate, a first-in-class therapy targeting alcohol-induced inflammation, now becomes one of the few mid-stage biotech programs to receive such substantial CRO-driven capital support. The partnership is
Sōlaria Biō has disclosed new mechanistic data showing that its synbiotic medical food, Bondia, reinforces gut barrier integrity, reduces systemic inflammation, and suppresses osteoclast activity—offering biological insight into the 85 percent improvement in bone density reported in a prior large-scale clinical trial. These results support Bondia’s positioning as a novel intervention for osteopenia and age-related