Regulation

The FDA has set a 30 April 2027 review deadline for NCX 470, a nitric oxide-donating bimatoprost eye drop targeting open-angle glaucoma.

The companies' 2026-2027 mRNA COVID-19 vaccine, targeting the XFG variant, has been approved for high-risk adults and children aged five and over.

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

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.