SOFIE Biosciences doses first patient in Phase 3 trial of novel cancer imaging agent

The study will run across 18 sites and enroll roughly 200 patients over 24 months

Biohaven reports Phase 2 depression trial results

Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials

Edgewise Therapeutics reports positive updates from HCM drug EDG-7500

CIRRUS-HCM, an open-label, multi-part study, evaluates EDG-7500 in patients with obstructive and nonobstructive HCM

INOVIO’s DNA therapy for rare throat disease gets FDA review

INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway

Briefs: CuraTeQ Biologics, Sigachi Industries and Natural Capsules

CuraTeQ Biologics and BioFactura USA to terminate agreement mutually

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity

EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation

Teva moves within reach of investment grade as S&P upgrades credit rating & Moody’s positive

Gilead licenses Assembly Bio's investigational Herpes drugs after positive phase 1b data

Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option

Biocon Biologics expands FKB deal to secure global rights for Adalimumab biosimilar

Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized