Regulation

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

Trimedx says new natural-language AI capabilities in TMX Protect cut medical device cybersecurity remediation time by 75% on average.

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

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.

Voluntary, vaguely documented US health industry agreements on drug prices and nutrition may fade without federal enforcement mechanisms, analysts warn.

Alvotech and Lotus Pharmaceutical will co-commercialise durvalumab and emicizumab biosimilars across the US and eight Asian markets.

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.

Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.

SeaStar Medical added three top-rated children's hospitals to its QUELIMMUNE customer base and enrolled 223 of 339 patients in its adult AKI pivotal

Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.

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

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

Erasca's ERAS-0015 has received Fast Track Designation for metastatic pancreatic adenocarcinoma, backed by a 57% response rate in second-line KRAS-mutant patients.

The NASDAQ-listed women's health company said the modular submission route lets regulators review key components before final FINALE trial data are available.