Guidance paves the way for NHS access for eligible adults in England and Wales

Original title: “Aquipta recommended by NICE for acute migraine treatment”

The discontinuation of Sanofi’s Phase 3 study for its complement inhibitor drug in chronic inflammatory demyelinating polyneuropathy delivers an ‘obviously disappointing’ blow to the broader drug class, according to William Blair.

Original title: “Sanofi cans late-stage study for rare autoimmune disease on underwhelming efficacy”

Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen innovation.

Original title: “FDA Expands Sunscreen Options for the First Time in 20 Years”

SMC backs first GPRC5D‑targeting bispecific for patients after three or more treatments

Original title: “Talvey accepted for use in Scotland for relapsed and refractory multiple myeloma”

While Merck and Gilead Sciences reported back-to-back late-stage victories for their weekly HIV pill, the partners also discontinued a Phase 3 program for their cancer combo after disappointing lung cancer survival data.

Original title: “Merck, Gilead serve ‘sweet and sour’ spread after HIV win, cancer stumble”

AstraZeneca is pushing its small molecule GLP-1 drug to Phase 3 development for weight control, diabetes and other cardiometabolic conditions despite the asset failing to best one from Structure Therapeutics.

Original title: “ADA: AstraZeneca hands Structure a win with ‘relatively underwhelming’ GLP-1 pill data”

Newly approved weight loss pill Foundayo reduced blood sugar more than Novo Nordisk’s semaglutide and other comparators in multiple Phase 3 type 2 diabetes trials. Eli Lilly will seek approval in this indication.

Original title: “ADA: Lilly bests Novo again, takes GLP-1 pill Foundayo to FDA for diabetes approval”

A combination involving Tango’s experimental therapy appeared to boost response rates in a small clinical trial well beyond what would be expected, sparking a share surge.

Original title: “Tango data add to growing momentum for pancreatic cancer drugs”

Daraxonrasib demonstrated statistically and clinically significant improvements in OS, PFS, and ORR in patients with previously treated metastatic pancreatic adenocarcinoma. We want you to take advantage of everything Cancer Therapy Advisor has to offer. To view unlimited content, log in or register for free. ... Register now at no charge to access unlimited clinical news, full-length features, case studies, conference coverage, and more. Patients with previously treated metastatic pancreatic adenocarcinoma (PDAC) assigned to daraxonrasib experience statistically and clinically superior results for survival and response compared with standard-of-care chemotherapy, according to findings presented at the ASCO Annual Meeting 2026. In the phase 3 multicenter RASolute-302 (NCT06625320) trial, investigators randomly assigned 228 patients to daraxonrasib and 231 to investigator’s choice of 1 of 4 standard chemotherapy regimens (gemcitabine/nab-paclitaxel, mFOLFIRINOX, nanoliposomal irinotecan plus 5-FU, or FOLFOX). “Daraxonrasib met all primary and key secondary endpoints with statistically significant and clinically meaningful improvements in overall survival, progression-free survival, objective response rate, and quality of life in patients with previously treated metastatic pancreatic cancer,” said study presenter Brian M.

Original title: “RASolute-302: Daraxonrasib Improves Survival, ORR in Metastatic PDAC - Cancer Therapy Advisor”

After Revolution Medicine’s groundbreaking data drop in April, its Tango-partnered combination approach has demonstrated what analysts called “unprecedented” results for 12 patients with pancreatic cancer, teeing up a late-stage study.

Original title: “‘WOW!’: RevMed and Tango’s pancreatic cancer combo achieves 92% response”

Treatment set to be used in routine multiple myeloma care

Original title: “First patient enrolled in German real‑world study of Pepaxti”

CURE connects oncology patients, survivors, and caregivers with expert guidance, cancer updates, treatment education, and clinical trial access. And that's really done through sequential clinical trials, understanding of medicine, where it works, where it doesn't, how safe it is, then building on that. Kristie L. Kahl: What are some of the current challenges that we still see with this disease that warrants further research? Dr. Steven M. Horwitz: The big challenge is most of our therapies to date. And then a generation of those that don't use a person's own T cells, different strategies, either another person’s cells, non–T-cell therapies. I think those are going to be tested in early-phase clinical trials now into the next year or two. I have some optimism that that we may find some areas where those are quite effective. Kristie L. Kahl: What do patients with this disease have to look forward to? Steven M. Horwitz: There's a lot going on, despite it being a rare disease. And I think most of the research is really aimed at understanding better therapies or developing better therapies and understanding how to better match them to patients most likely to benefit, not match them with patients least likely to benefit. I think there's a lot of energy looking at new therapies, and they're really focused on more potent and safer therapies. So, I think the optimism would be that there's a lot of people working on this. There are some real strategies there that may change things for the future. We have to work with each other and our patients to do the hard work of understanding those treatments, understanding how best and safely to use them. But there is sort of a broad, really international concerted effort to attack these diseases.

Original title: “Clinical Trials in Cutaneous T-Cell Lymphoma | CURE”

By inhibiting the APRIL cascade, Otsuka Pharmaceuticals’ Voyxact slowed kidney function decline in patients with IgAN, opening up a potential path for full approval while also reading through to Vertex and others with similar assets.

Original title: “Otsuka energizes IgA neuropathy space with new Phase 3 Voyxact data”

In some cases, sponsors have used RWE as pivotal evidence for accelerated approval in rare disease or as an external control arm in hybrid trial designs. Post-approval, RWD informs treatment pattern analysis, market positioning, and label expansion strategies. Across therapeutic areas, oncology ... In some cases, sponsors have used RWE as pivotal evidence for accelerated approval in rare disease or as an external control arm in hybrid trial designs. Post-approval, RWD informs treatment pattern analysis, market positioning, and label expansion strategies. Across therapeutic areas, oncology has the most developed evidence base, while urology remains in early piloting stages. As the FDA formally recognizes real-world evidence as eligible confirmatory evidence for drug approval, sponsors face a growing imperative to build the data infrastructure, organizational alignment, and analytical capabilities needed to use RWE effectively across the development lifecycle. interview with Applied Clinical Trials, "On the pragmatic spectrum, secondary data most realistically complements or replaces traditional trials on the observational side—post-market surveillance, label expansion, long-term safety assessments." Rare disease is another high-impact area, where small patient populations make randomization difficult or infeasible, and RWE can fill critical evidence gaps. Real-world evidence is the clinical evidence derived from analyzing that data. Historically used primarily for post-marketing surveillance, RWE has expanded significantly into earlier stages of development, including trial design, site selection, endpoint validation, and regulatory submissions. Its adoption reflects a broader recognition that controlled trial environments alone cannot capture the full complexity of how therapies perform in practice.

Original title: “Real-World Evidence in Clinical Trials: Where the Industry Stands and Where It's Headed | Applied Clinical Trials Online”

Shares for ADC Therapeutics fell more than 50% after a Phase 3 trial observed a death rate that at least one analyst believes “may be difficult to accept for physicians, patients and regulators.”

Original title: “An ADC specialist sinks on safety concerns for blood cancer drug”