Gazyva’s ALLEGORY data: what the SRI-4 and DORIS remission outcomes mean for lupus care
Genentech’s obinutuzumab met all ALLEGORY phase III endpoints in SLE. What the remission and flare data mean for lupus treatment strategy.
LRS wins FDA clearance to test ThermoSuit cooling device in pivotal ischemic stroke trial
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, […]
Could Invivyd’s VYD2311 offer a safer alternative to mRNA COVID vaccines for vulnerable groups?
Invivyd’s LIBERTY trial could reshape COVID prophylaxis by comparing VYD2311 antibody safety with mRNA vaccines. See what’s at stake for regulators.
Landmark FDA nod gives MSC developers long-awaited quality benchmark for clinical use
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.
How Brazil’s GMP approval for pembrolizumab biosimilar changes global biosimilar dynamics
Blau Farmacêutica’s pembrolizumab biosimilar earns ANVISA GMP approval—see what this means for Brazil’s global position in cancer immunotherapy.
Can ELEVIDYS meet its promise? Sarepta’s pivotal Duchenne gene therapy trial nears major milestone
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.
What AGC Biologics’ role in Waskyra tells us about the future of ethical cell therapy scale-up
Waskyra’s FDA and EMA approvals spotlight AGC Biologics’ rare disease manufacturing model. Find out what this means for future nonprofit-led therapies.
Camurus’s FDA review restart for Oclaiz puts long-acting octreotide on track for a potential U.S. launch in mid-2026
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 […]
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.
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.