North America

Remibrutinib becomes the first FDA-approved therapy for symptomatic dermographism, doubling Rhapsido's approved indications in chronic hives.

Rezera's RESOLVE-2 Phase 2 trial showed ruvonoflast added significant hsCRP reductions to semaglutide therapy, with no new safety signals observed.

TISSIUM has treated its first US patients with the ECLIPSIUM System in a 240-patient IDE trial comparing non-penetrating mesh fixation against resorbable tacks.

Vaxcyte priced concurrent equity and $500m convertible note offerings to bankroll its 31-valent pneumococcal vaccine through Phase 3 and potential US launch.

The North Carolina biotech's oral Nrf2/Bach1 modulator HPPD has received FDA Orphan Drug Designation for sickle cell disease, backed by preclinical fetal haemoglobin

Petrelintide cut body weight by up to 9.2% versus 2.0% on placebo in the ZUPREME-2 trial, with near-placebo gastrointestinal discontinuation rates.

The FURVENT trial's firmonertinib failed to beat chemotherapy on BICR-assessed progression-free survival in first-line EGFR exon 20 insertion-mutant NSCLC.

BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.

The Brisbane biotech adds at least one new target to its Lilly collaboration, with total milestone-contingent deal value potentially exceeding $870 million.

Jupiter Neurosciences has begun dosing in the RESET trial of JOTROL in Parkinson's disease while simultaneously exploring a sale or licensing of its assets.

A Spherix Global Insights survey shows physician confidence in autologous CAR-T fell sharply after trial pauses at Novartis and Bristol Myers Squibb.

Joint venture Klothonova has shown GMP-banked Klotho-producing cells remain viable and secrete therapeutic protein inside Cell-in-a-Box capsules.

Ernexa Therapeutics has appointed oncology veteran Robert Spiegel to its board as it targets a Q4 2026 IND filing for its lead iMSC cell therapy.

NorthStrive Biosciences has signed a statement of work with Charles River Laboratories to characterise plasmid copy numbers in its EL-22 and EL-32 engineered

Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15

Climb Bio will present preliminary PrisMN Phase 2 data on budoprutug in membranous nephropathy at ASN Kidney Week in Denver this October.

Elutia has cleared its final 2026 funding milestone, receiving the full $8m holdback from its BioEnvelope sale with no indemnity claims.

Phase 1b open-label extension data show no clinically meaningful motor progression in 12 Parkinson's patients after a full year of daily oral rexaceract.

Phase 2 data show Rina-S achieved a 45.9% objective response rate and 12.1-month median duration of response in heavily pretreated platinum

New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.