Related coverage linked through entity extraction aliases.
May 26, 2026
BioNTech faces mixed analyst views as Bernstein initiates with a cautious Market Perform rating, while the company secures FDA Fast Track designation for BNT113 and prepares for a shareholder vote on capital restructuring and leadership transition.
May 23, 2026
Johnson & Johnson faces new talc verdicts in Minnesota and Pennsylvania totaling over $10 million, with 67,000+ lawsuits pending. Meanwhile, the FDA approved a new monthly dosing for RYBREVANT FASPRO, and the company launched its Shockwave C2 Aero coronary catheter globally.
May 22, 2026
A phase II trial of TAK-007 CAR-NK therapy in R/R B-cell NHL showed a 60.9% overall response rate. Preclinical CAR-NKT therapy eliminated endometrial tumors in models. Optimized costimulatory domains (2B4-DAP12) boosted CAR-NK tumor killing.
May 22, 2026
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
May 21, 2026
The FDA has accepted Ascelia Pharma's NDA for Orviglance, a manganese-based oral MRI contrast agent for liver imaging in patients with severe kidney impairment, and set a PDUFA action date of July 3, 2026.
May 21, 2026
Acrivon Therapeutics said its wholly owned laboratory in Watertown received Massachusetts CLIA certification with a full license to conduct patient testing and develop companion diagnostics. The company said the lab is expected to be fully operational in the first half of 2026 and will support targeted therapeutics development.
May 22, 2026
A comparative study found Canadian patients waited more than 90 weeks longer than Americans and 65 weeks longer than Europeans for new drugs approved between 2019 and 2025. The report said late submissions to Health Canada, along with price controls and other market factors, were the main drivers.
May 21, 2026
The FDA finalized a framework for reviewing food chemicals already on the market and launched assessments of BHT and ADA. Public comments on both reassessments are open until July 13, 2026.
May 21, 2026
Sentante secured CE-mark approval for its multi-domain robotic platform and was accepted into the FDA’s total product life cycle advisory programme. The moves support European commercialization and planning for remote stroke thrombectomy clinical studies.
May 21, 2026
The FDA approved Novocure’s Optune Pax, a wearable tumor-treating fields device, for pancreatic cancer in combination with chemotherapy. Phase III PANOVA-3 data showed delayed pain progression and improved one-year overall survival in inoperable locally advanced disease.
May 20, 2026
Research and Markets added two cell and gene therapy publications, including a tools and reagents market report forecasting growth from $12 billion in 2025 to $19.8 billion by 2030. The reports track approvals, financing, deals, and manufacturing developments.
May 20, 2026
ImmunityBio said the FDA accepted its sBLA for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease. The PDUFA date is Jan. 6, 2027.
May 20, 2026
Cinclus Pharma said its first Phase III study is nearing full enrollment, with topline results expected in the fourth quarter of 2026. The company also reported regulatory progress for linaprazan glurate and a EUR 28 million financing agreement.
May 20, 2026
The FDA fast-tracked an inhalable gene therapy for advanced lung cancer after an early 11-patient trial showed tumour shrinkage in three patients and disease stabilization in five. Larger studies involving about 250 patients are underway.
May 20, 2026
Cell and Gene Therapy Catapult has established a Technology Advisory Board to support technology deployment across advanced therapies. The board will focus on data, manufacturing, testing and patient pathways.
May 20, 2026
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
May 20, 2026
The FDA issued a Complete Response Letter for Disc Medicine’s bitopertin NDA in EPP, saying additional evidence is needed. The agency wants Phase 3 APOLLO data before deciding.
May 16, 2026
The FDA approved Tecentriq and Tecentriq Hybreza for adjuvant muscle-invasive bladder cancer with ctDNA molecular residual disease after cystectomy. The Phase III IMvigor011 study showed a 36% reduction in recurrence or death and a 41% reduction in death.
May 20, 2026
The FDA granted orphan drug designation to AstraZeneca’s surovatamig for follicular lymphoma. The status supports development for rare diseases but is only an early regulatory step.
May 19, 2026
The FDA granted Orphan Drug Designation to Cullinan Therapeutics’ CLN-049 for relapsed/refractory AML. CLN-049 is in Phase 1 studies and had already received Fast Track designation.
