Acadia Pharmaceuticals has announced U.S. Food and Drug Administration approval for DAYBUE STIX (trofinetide) for oral solution, a new powder-based formulation of its existing drug DAYBUE used in the treatment of Rett syndrome. The approval covers use in adult and pediatric patients two years and older and is based on bioequivalence data, not new clinical […]
Why this collaboration marks a turning point for AI-driven breast cancer diagnostics The ECOG-ACRIN Cancer Research Group and Caris Life Sciences have released early findings from a large-scale collaboration aimed at transforming how recurrence risk is predicted in early-stage breast cancer. Presented at the 2025 San Antonio Breast Cancer Symposium, the joint effort has produced […]
Privo Technologies has officially initiated dosing in a Phase 1/2 trial evaluating PRV131, its nanoengineered intratumoral cisplatin injectable, for the treatment of T1–T3 oral squamous cell carcinoma (OSCC). The trial, designated Arm 3 of the CLN-004 study, will explore PRV131 as a neoadjuvant therapy aimed at shrinking tumors before surgery. The announcement marks a pivotal […]
Lee’s Pharmaceutical Holdings Limited has acquired the Staccato One Breath Technology platform and related assets from Alexza Pharmaceuticals, gaining exclusive rights to manufacture and license Staccato alprazolam under its global agreement with UCB. The transaction expands Lee’s Pharmaceutical’s inhalation drug delivery pipeline, deepens its foothold in central nervous system therapies, and positions the company to […]
Medical Manufacturing Technologies has been acquired by Perimeter Solutions for $685 million in a cash-backed deal, marking a strategic shift for the Clayton, Missouri-based specialty chemicals company toward the precision-driven medical manufacturing sector. The acquisition, announced by both parties in December 2025, is expected to close in the first quarter of 2026, subject to regulatory […]
NewcelX Ltd. has announced the publication of its international DOXA compound patent in China, further securing intellectual property protection for its cross-domain pipeline in neurology and metabolic diseases. The patent application covers a new class of small molecules derived from quinazoline, benzothiazine, and benzoxazine scaffolds. These compounds are designed to modulate orexin signaling, neuroinflammation, and […]
MATELASER, INC. has launched the W1 REGEN Series, a wearable cold laser therapy device delivering 5,100 mW/cm² of dual-wavelength red and near-infrared light through a 24-gram unit, positioning it as the lightest high-power photobiomodulation device ever commercialized. The official debut, coupled with a Kickstarter campaign and a planned CES 2026 showcase, marks an aggressive bid […]
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 […]
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 […]
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 […]