Disease

LISRAYA becomes the first targeted oral therapy approved for dermatomyositis, backed by Phase 3 data showing significant steroid-sparing and disease-activity benefits.

LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.

Verrica Pharmaceuticals has finished enrolling its first pivotal Phase 3 warts trial, with topline data expected in Q1 2027 and a second trial over 50

BridgeBio has initiated ASCEND-ATTR, a 150-patient study testing whether long-term acoramidis can reverse cardiac damage in ATTR-CM.

SOTIO Biotech's LRRC15-targeting antibody-drug conjugate gained Fast Track Designation, with a first-in-human study expected before year end.

Femasys and UNC Health have partnered to offer in-office fertility diagnostics and intratubal insemination across the academic system's statewide OB/GYN locations.

INmune Bio has submitted an orphan drug designation application and pre-MAA scientific advice package to the EMA for its cell therapy Ebstrocel in RDEB.

JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.

A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.

Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.

Mesoblast reported sevenfold revenue growth in FY2026, driven by RYONCIL's US commercial launch, while its Phase 3 back pain trial completed patient treatment.

MicrobiotiX's MP101 bacteriophage candidate passed its 72-hour safety review in South Korea's first MFDS-approved phage therapy trial.

APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse

Ascendis Pharma will present Week 104 ApproaCH Trial data on navepegritide in achondroplasia, with FDA approval secured and an EMA decision due Q4 2026.

CELZ-201 / Olastrocel has treated all patients across the FDA-cleared ADAPT trial, including the opioid cohort, ahead of RMAT evaluation and Phase 3 planning.

SPY072 showed statistically significant benefits in rheumatoid arthritis but fell short of Spyre's internal threshold to advance it as a standalone therapy.

ADARx Pharmaceuticals has secured Fast Track designation for its siRNA candidate onvuzosiran, now in Phase 3 trials for HAE prophylaxis.

Alvotech has licensed two biosimilar candidates to Lotus Pharmaceutical across the US and eight Asian markets, with milestone payments potentially reaching $150 million.

Biomea Fusion has fully enrolled its Phase II trial of oral menin inhibitor icovamenib in insulin-deficient type 2 diabetes, with topline data expected in

The FDA has pushed Deramiocel's PDUFA date to 22 November 2026 after Capricor submitted 24-month HOPE-3 open-label extension data.