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May 13, 2026
ABL111 received FDA agreement on an accelerated approval pathway for metastatic gastric cancer as the first patient was dosed in a global phase 2 trial. The companies said ORR will support accelerated approval and phase 2 is evaluating ABL111 with nivolumab and mFOLFOX6.
May 13, 2026
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
May 13, 2026
A phase 2 trial in high-risk smoldering multiple myeloma found all 20 patients treated with cilta-cel became MRD-negative within two months and remained so after 15.3 months. No disease progression, death, dose-limiting toxicities, or high-grade side effects were observed.
May 13, 2026
Moleculin said its MIRACLE Phase 2B/3 AML trial is nearing first unblinding, with blinded CRc above 40% and CR around 30%. The first 45-subject readout is expected before June 30, 2026.
May 13, 2026
The FDA reversed its refusal to review Moderna’s mRNA flu vaccine application and accepted a revised filing with split age cohorts and a post-market study for adults over 65. The reversal came amid broader vaccine regulatory uncertainty and industry concern about unpredictable review timelines.
May 13, 2026
Eli Lilly reported positive phase 3b Together-PsO results for Taltz plus Zepbound in adults with plaque psoriasis and obesity or overweight. Separate meeting updates highlighted new oral plaque psoriasis therapies with biologic-like efficacy.
May 12, 2026
Telix said Part 1 of the ProstACT Global Phase 3 study met its primary objectives for TLX591-Tx in mCRPC. The company reported acceptable safety, no new safety signals and progression plans for Part 2.
May 12, 2026
A study of 100 adults with diabetes found broad comfort with AI-based diabetic retinopathy screening, but most participants wanted physician oversight. The findings come as AI tools move further into community diabetes care.
May 12, 2026
Rhythm reported Q1 2026 IMCIVREE revenue of $60.1 million and said more than 150 patient start forms were received after U.S. approval in acquired hypothalamic obesity. The company also cited European authorization and a Japanese application under review.
May 12, 2026
A review in Genes & Diseases says robust non-clinical safety assessment is critical for CRISPR-based gene therapies. It highlights genotoxic, delivery, and immunological risks and recommends risk-based development programs.
May 11, 2026
A pooled analysis of five randomized trials found intranasal esketamine improved MADRS scores in adults with TRD in both sexes. Females showed greater improvement and higher odds of treatment-response toward trial end.
May 11, 2026
The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.
May 11, 2026
NIH said it will no longer classify BESH studies as clinical trials for grant applications due on or after May 25, 2026. The change removes ClinicalTrials.gov registration and reporting requirements for those studies.
May 11, 2026
LIB Therapeutics launched Lerochol in the United States after FDA approval for lowering LDL-C in adults with hypercholesterolemia, including HeFH. The once-monthly PCSK9 inhibitor is available with a $199-per-month cash-pay option.
May 11, 2026
Tracy Beth Høeg said in her first address to staff that she will scrutinize antidepressants and RSV products used to protect babies. She said she is prioritizing the health of women and babies.
May 10, 2026
Insulin list prices rose more than 300% over two decades as PBMs face growing scrutiny over rebates, spread pricing, and transparency. Reform efforts and pharmacist involvement are central to drug affordability and access.
May 10, 2026
The FDA expanded efgartigimod approval to all adult generalized myasthenia gravis serotypes. Phase 3 ADAPT SERON met its primary endpoint and showed no new safety signals.
May 08, 2026
PSMA-PET imaging leads to earlier use of advanced therapies like ARPIs in prostate cancer patients compared to bone scans. Real-world data on 177Lu-PSMA-617 shows comparable efficacy to the VISION trial in mCRPC patients.
May 07, 2026
argenx reported $1.3B in Q1 2026 global product net sales (63% YoY growth). The FDA PDUFA target date for seronegative gMG is May 10, 2026. Positive ADAPT OCULUS results support an oMG label expansion. Pipeline milestones include myositis readout in Q3 2026 and MMN readout in Q4 2026.
May 05, 2026
Cellectar Biosciences expanded its global IP estate and announced oversubscribed financing of up to $140 million. The funding supports iopofosine I 131 regulatory filings and a confirmatory study in Waldenström macroglobulinemia.
