Guardant Health partners with Manulife to launch its Shield MCD blood test in Hong Kong, Singapore and the Philippines. Analysis of what this means for oncology.
TETON-2 phase 3 data show nebulized treprostinil slows IPF lung decline and cuts clinical worsening risk. Analysis of what the NEJM results mean.
Genentech's obinutuzumab met all ALLEGORY phase III endpoints in SLE. What the remission and flare data mean for lupus treatment strategy.
Life Recovery Systems (LRS), a medical device developer headquartered in Alexandria, Louisiana, has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration to advance its ThermoSuit System into a pivotal clinical trial enrolling ischemic stroke patients. The study, which will enroll up to 160 patients across as many as eight hospitals,
Invivyd’s LIBERTY trial could reshape COVID prophylaxis by comparing VYD2311 antibody safety with mRNA vaccines. See what’s at stake for regulators.
The FDA has recognized Tasly’s 3P assay as the first quality control standard for MSCs. Find out what this changes for developers and regulators.
Blau Farmacêutica’s pembrolizumab biosimilar earns ANVISA GMP approval—see what this means for Brazil’s global position in cancer immunotherapy.
Sarepta’s EMBARK 3-year readout could clarify ELEVIDYS’ long-term role in Duchenne care. Find out what’s at stake in this pivotal gene therapy trial.
Waskyra’s FDA and EMA approvals spotlight AGC Biologics’ rare disease manufacturing model. Find out what this means for future nonprofit-led therapies.
Camurus AB announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmission of the New Drug Application for Oclaiz (CAM2029), an extended-release octreotide injection for acromegaly. The agency assigned a Prescription Drug User Fee Act (PDUFA) action date of June 10, 2026, reinitiating regulatory review after an earlier Complete Response Letter related