Tolerability is a key factor in the appeal of Enliven Therapeutics Inc.’s ELVN-001 for previously treated chronic myeloid leukemia (CML), which yielded positive updated phase I data from the Enable trial. Dennis Kim, hematologist from Princess Margaret Cancer Center in Toronto, said he would use the drug for a patient “who doesn’t have any other options.” Read More
Dermasensor Inc. received CE mark approval for its handheld skin cancer detection device using spectroscopy and AI to test suspicious skin lesions for cancer in real time at the point of care. The device is designed to help qualified healthcare professionals decide whether suspicious skin lesions need further investigation. With skin cancer rates rising, the Dermasensor joins several other AI-based tools entering the European market to help with the analysis of suspicious lesions. Read More
China’s National Medical Products Administration has approved Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), through priority review for adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received at least one trastuzumab-containing regimen. Read More
Laekna Inc. is handing ex-China rights to internally discovered PI3Kα pan-mutant selective inhibitor LAE-118 to U.S.-based Vasque Bio Inc. in a deal worth up to $527 million, marking another asset-monetization move by the Shanghai company as it looks to fund and accelerate development across its oncology and metabolic disease pipeline. Read More
Ethyreal Bio Inc. has come out of stealth mode in order to disclose preclinical data for ETHY-001, its monoclonal antibody targeting thyroid stimulating hormone receptor, at the Endocrine Society’s 2026 annual meeting on June 15. Read More
The biotech industry delivered another year of strong headline performance in 2025, yet beneath the surface, a growing divide between the industry’s haves and have-nots is reshaping every dimension of how companies raise money, build pipelines and navigate an increasingly volatile policy environment. That is the message of the EY Biotech Beyond Borders Report 2026, an annual industry analysis produced by EY Insights that framed the sector’s defining challenge in a single question: “How can biopharma keep its balance?” Read More
In a repeat move, the U.S. FDA issued yet again a complete response letter (CRL) to Camurus AB for its subcutaneous extended-release injection drug CAM-2029 (octreotide) to treat the rare chronic growth disorder acromegaly. The drug, which expects to be branded Oclaiz in the U.S. upon approval, is called Oczyesa in the EU and the U.K., where it received marketing authorization in 2025. Read More
New hires and promotions in the biopharma and med-tech industries, including: Aldeyra, Covalon, Cytospire, Hansa, Phoremost, Rakuten, Vascarta. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Alnylam, Cordex, Cosylab, Excellthera, Genesis, Heron, Medexus, Predicta, Sensorion, Tenacia, Verge. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Cellectis, Dermasensor, Eli Lilly, Italfarmaco, Onkos, Organon, Radiomedix, Sibel, Subtle, Takeda, Tris, Vara. Read More
