Regulation

Radar Healthcare has bought patient experience platform Cemplicity to link PREMs and PROMs data with its quality and safety workflows.

Gyre posted Q2 revenue of $29.1m and reaffirmed full-year guidance of up to $111m as its Cullgen acquisition added a protein-degrader pipeline.

IMVANEX is now authorised in the EU for children aged 2 to 11, backed by Phase 2 data showing non-inferior immune responses versus adults.

CG Oncology says PIVOT-006 has accrued most target events, with topline data imminent and a BLA submission for bladder cancer due in Q4 2026.

The MIT spinout will use five-year federal funding to develop a magnetic robotic navigation platform for autonomous endovascular thrombectomy.

The Toronto-listed theranostic company said 12-month Tigris trial data showed a 13.9% absolute mortality reduction versus standard care.

Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.

Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.

The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.

Pharvaris published the first qualitative disease-burden study in AAE-C1INH, informing endpoint selection for its ongoing Phase 3 CREAATE trial of deucrictibant.

Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m

Priovant's BEACON+ study targets a rare inflammatory skin disease with no approved therapies, with topline data expected in 2028.

NewAmsterdam Pharma secured a positive CHMP opinion for obicetrapib in Europe as its 9,500-patient PREVAIL outcomes trial heads toward an interim readout.

Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases

Arcutis posted Q2 net product revenue of $129.9m, up 59% year-on-year, and lifted its full-year sales guidance to $525m–$540m.

The Danish pharma giant raised its full-year adjusted sales and operating profit guidance, citing higher-than-expected demand for its GLP-1 product portfolio.

BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.

Adneuris Therapeutics receives $35m upfront as it grants Maruishi Pharmaceutical exclusive rights to develop its dual-receptor pain candidate in two Asian markets.

Eton has acquired US rights to topical timolol gel ASN-001, targeting moderate infantile hemangiomas with an NDA filing planned for late 2027.

The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.