FDA announces results from the largest and most rigorous examination ever conducted focused on chemical contaminants in infant formula available on the U.S. market.

Original title: “FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S. ”

This will help us accelerate promising therapies, and build toward our ultimate goal of running real-time, continuous trials across all phases of drug development.” · The FDA is announcing the successful initiation of proof-of-concept RTCTs by AstraZeneca and Amgen. AstraZeneca is conducting a Phase 2 multi-site trial, TRAVERSE, in patients with treatment... This will help us accelerate promising therapies, and build toward our ultimate goal of running real-time, continuous trials across all phases of drug development.” · The FDA is announcing the successful initiation of proof-of-concept RTCTs by AstraZeneca and Amgen. AstraZeneca is conducting a Phase 2 multi-site trial, TRAVERSE, in patients with treatment-naïve mantle cell lymphoma, with participation from The University of Texas MD Anderson Cancer Center and University of Pennsylvania. We demonstrated that it is not only possible, but also potentially transformative for the clinical trials ecosystem,” said Chief AI Officer Jeremy Walsh. “We have to consider our processes from the standpoint of a patient awaiting a potentially powerful treatment.” White Oak, Md., April 28, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the successful initiation of two proof-of-concept clinical trials that will report endpoints and data signals to the agency in real time. Early-phase clinical trials are a bottleneck in drug development, often characterized by high uncertainty, limited patient populations, and inefficient decision-making processes. Data is typically reported from sites to sponsors, who analyze and subsequently submit data to the FDA.

Original title: “FDA Announces Major Steps to Implement Real-Time Clinical Trials - BioSpace”

Phase 1/2 data from 2 separate studies have shown signals of improved survival and safety with the agent, supporting its evaluation in a phase 3 trial. Phase 1/2 data from 2 separate studies have shown signals of improved survival and safety with the agent, supporting its evaluation in a phase 3 trial. ... First-line treatment with daraxonrasib (RMC-6236) as either monotherapy or in combination with chemotherapy demonstrated antitumor activity and disease control in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), with both regimens producing outcomes that numerically exceed historical benchmarks observed with standard chemotherapy in this setting.1,2 Two phase 1/2 datasets (NCT05379985; NCT06445062) evaluating the oral, potent, RAS(ON) multi-selective inhibitor as first-line therapy for metastatic PDAC were presented at the · 2026 AACR Annual Meeting. Together, they offer the first comprehensive look at the agent's activity in the treatment-naive setting. In the monotherapy study, presented by Eileen M. O’Reilly, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, daraxonrasib produced an overall response rate (ORR) of 47% (95% CI, 31%-64%) and a disease control rate (DCR) of 92% (95% CI, 79%-98%) in efficacy-evaluable patients with RAS-mutant metastatic PDAC (n = 38).1 In the all-RAS-mutant population (n = 40), the Kaplan-Meier–estimated 6-month progression-free survival (PFS) rate was 71% (95% CI, 53%-83%), and the 6-month overall survival (OS) rate was 83% (95% CI, 67%-92%). Patients with primary central nervous system (CNS) tumors, active brain metastases, or impaired gastrointestinal (GI) function were excluded. Patients with metastatic recurrence following prior treatment for localized disease were permitted to enroll, provided the diagnosis occurred more than 6 months after the last dose of systemic therapy. Liver metastases were present in 70% and 68% of patients at enrollment, and 50% and 48% were metastatic at diagnosis, with 95% having stage IV disease at study entry in the monotherapy cohort. Prior anticancer therapy in the non-metastatic setting was reported in 48% and 38% of patients, including 45% who received adjuvant or neoadjuvant therapy and 3% with locally advanced disease in the combination cohort; 28% of patients received FOLFIRINOX, and 10% received gemcitabine plus nab-paclitaxel in the monotherapy cohort.

Original title: “Daraxonrasib Demonstrates First-Line Activity With/Without Chemotherapy in Metastatic PDAC | OncLive”

An FDA initiative to implement real-world clinical trials could dramatically accelerate the pace at which new treatments become available to patients, according to physicians from two institutions involved in the effort’s initial phase.The approach will leverage electronic health records ... An FDA initiative to implement real-world clinical trials could dramatically accelerate the pace at which new treatments become available to patients, according to physicians from two institutions involved in the effort’s initial phase.The approach will leverage electronic health records and an AI-powered platform to allow FDA scientists to track safety signals and efficacy endpoints while Makary called the initiative “a critical step” in the agency’s broader goal to facilitate continuous trials and move away from the traditional clinical development model that consists of multiple distinct phases — each with its own protocol, a separate study and lag time in between. Two proof-of-concept real-time trials — both of which are evaluating oncology therapies — got underway this month. The randomized phase 2 TRAVERSE study is evaluating acalabrutinib (Calquence, AstraZeneca) in combination with venetoclax (Venclexta; AbbVie, Genentech) and rituximab for treatment-naive mantle cell lymphoma. This could open the door for application of data science to multiple different aspects of how we evaluate novel therapies, which ideally — in aggregate — could result in speeding up the process.” · Jennifer Keating Litton, MD, MHCM, can be reached at [email protected]. Emma A. Meagher, MD, can be reached at [email protected]. ... FDA announces major steps to implement real-time clinical trials. We need our clinical trials to evolve at the same pace that scientific breakthroughs are happening,” Jennifer Keating Litton, MD, MHCM, chief clinical research officer and professor in the department of breast medical oncology at The University of Texas MD Anderson Cancer Center, told Healio.

Original title: “Real-time clinical trials may ‘fundamentally transform’ research landscape”

FDA announces cancer drug trials by AstraZeneca and Amgen will be monitored in real time, a test of how to shorten time interval between trial phases. Monitoring trials in real time may help shorten the time interval between trial phases. The agency also asked the public to weigh in on a potential pilot program to work with companies that use AI to enhance safety monitoring and medication dose selections, identify safety signals, and improve patient recruitment in clinical trials. ... AstraZeneca is conducting a Phase 2 trial of its combination therapy for patients with an aggressive form of lymphoma. The trial will take place at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen is conducting a Phase 1b trial of its treatment for small cell lung carcinoma. WASHINGTON — The Food and Drug Administration on Tuesday announced efforts to make clinical trials more efficient, starting by reviewing data in real time from trials conducted by AstraZeneca and Amgen.

Original title: “FDA testing speedier drug development with real-time clinical trials | STAT”

FDA Commissioner Marty Makary announces AstraZeneca proof-of-concept real-time clinical trial. “For the first time, FDA regulators will be able to see what’s happening in a clinical trial, looking at endpoints in the cloud as they occur,” writes FDA commissioner. To build on this success, we will be launching a broader real-time clinical trials pilot program this summer that will evaluate expanded cloud-based systems, define standardized metrics for success, and bring more sponsors into this new, dynamic regulatory paradigm. ... By coupling these design principles with real-time data streaming, we can bring unbroken drug development to all disease areas. Whether we are fighting rare genetic disorders, autoimmune diseases, or widespread chronic conditions, continuous trials will ensure that data informs decisions instantly. Every time, I wondered: “Why can’t we, as a modern society, figure out a way to make powerful treatments available sooner to those who are willing to try them?” Those experiences had a profound impact on my thinking and have shaped our reforms. By viewing safety signals and clinical endpoints in real time, FDA scientists can detect adverse reactions sooner, potentially enhancing patient safety. Conversely, when a new therapy is showing strong efficacy, we can identify that success rapidly. Real-time trials are not just technically possible; they are transformative for the entire clinical ecosystem. Historically, trials have required tedious tabulations and repeated application submissions between phases, which is why 45% of the time from a Phase 1 trial until final submission is spent without any ongoing clinical trial in progress — idle time in the system. ... On Tuesday the Food and Drug Administration announced a bold new approach that could fundamentally transform the development of new treatments: real-time clinical trials.

Original title: “FDA’s scientists can now see clinical trial endpoints in real time | STAT”

Survodutide spurred weight loss Wall Street analysts referred to as “Wegovy-like,” and showed signs it might help preserve muscle mass as well.

Original title: “Boehringer dual-acting obesity shot hits mark in Phase 3 trial”

As a result, targeted radionuclide ... of new treatment approaches, tailored to the nature and biology of different tumors. Later this year, a UK-based biotech company called Nuclide Therapeutics, is planning a clinical trial in lung cancer patients, a population with notoriously low overall survival rates. “The symptoms don’t often show until the disease has spread, ... As a result, targeted radionuclide therapy is set to become ever more varied and sophisticated in the coming years and could ultimately lead to a broad array of new treatment approaches, tailored to the nature and biology of different tumors. Later this year, a UK-based biotech company called Nuclide Therapeutics, is planning a clinical trial in lung cancer patients, a population with notoriously low overall survival rates. “The symptoms don’t often show until the disease has spread, making surgery difficult, and the cancer develops therapy resistance at a rapid rate,” says Tim Witney, professor of molecular imaging at King’s College London, and the company’s co-founder & CSO. Breakthroughs in identifying tumor biomarkers in liver, gastric, prostate, lung and other cancers and are accelerating radionuclide therapies. After being approved by the FDA in early 2022, it has emerged as a novel life-extending option for patients with advanced disease. ... The success of this drug has resulted in PSMA becoming a focal point for other radionuclide therapies aimed at advanced prostate cancer. Bayer has two early-stage clinical trials in progress using PSMA to deliver higher energy radionuclides to patients with metastatic disease. But once there’s data that shows, ‘Ok, this is safe and also as effective as standard treatments,’ then radiopharmaceuticals could be moved up as a first-line option where it’s the patient’s and physician’s choice about which treatment they want to receive.” · I look forward to watching these clinical trials carefully over the coming years—and one day, hopefully, welcoming a new standard tool into our toolbox for treating cancer.

Original title: “Precision Radiation Therapy Could Offer New Hope For Hard-To-Treat Cancers”

EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). The purpose of the pilot is to test a new regulatory…

Original title: “New pilot to support development of ‘breakthrough’ medical devices”

US study marks company’s second clinical trial of ovarian cancer therapy

Original title: “Theolytics announces first patient dosed in the Octopod‑IP trial”

A therapy that works similarly to AbbVie’s blockbuster Skyrizi appeared more potent in a mid-stage trial and has the potential to be dosed less frequently.

Original title: “Oruka surges as long-acting psoriasis drug shows early promise”

The results could support the first approval in decades for an oral medicine that can treat male pattern baldness, though the therapy will face competition from generics and over-the-counter medications.

Original title: “Veradermics soars on positive data for baldness treatment”

While tovecimig met the main goal of progression-free survival in a Phase 2/3 trial, it did not improve overall survival.

Original title: “Compass shares crash as ‘confounding’ survival data raise approvability questions for bispecific”

Clesrovimab is first monoclonal antibody offering a single fixed dose for infants

Original title: “UK medicines regulator grants marketing authorisation to Enflonsia for RSV prevention”