The Food and Drug Administration (FDA) is announcing the renewal of the Antimicrobial Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Antimicrobial Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 7, 2028, expiration date.

Original title: “Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal”

The Food and Drug Administration (FDA or Agency) is requesting nominations for qualified individuals to serve as voting members of FDA's standing public advisory committees and panels (collectively, advisory committees). This notice covers scientific, technical, professional, and other voting-member positions in which appointees serve as individuals rather than as designated representatives; it does not solicit nominations for consumer representative or industry representative positions. FDA wil

Original title: “Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees”

Published phase 1 findings support the promising efficacy and tolerability of anito-cel in relapsed/refractory multiple myeloma, explains lead author Matthew Frigault, MD. The phase 1 trial evaluated anito-cel, which uses a synthetic d-domain BCMA binder (ddBCMA), at 2 dose levels, 100 × 10⁶ CAR-positive T cells and 300 × 10⁶ CAR-positive T cells, in patients with relapsed or refractory multiple myeloma who had received 3 or more prior lines of therapy or had triple-class refractory disease; almost 70% were penta-drug refractory. The primary end points were adverse events during the treatment period and establishment of the recommended phase 2 dose. Among 75 of 117 treated patients who received at least 3 prior lines of therapy and were evaluated for minimal residual disease (MRD), ... At the International Myeloma Society Annual Meeting, matching-adjusted indirect comparisons comparing iMMagine-1 patients to those in pivotal trials of bispecific antibodies found higher odds of deep responses with anito-cel vs teclistamab (Tecvayli) and talquetamab (Talvey) as fourth-line treatment.4 Frigault viewed the lack of these rare but serious neurotoxicities at this longer follow-up as promising and also stressed the lack of immune effector cell–associated enterocolitis, another notable delayed complication of commercially available CAR T-cell therapy. “These were great results for a phase 1 trial,” senior author Michael R. He said that currently, CAR T–treated patients are monitored for months for neurotoxicities and enterocolitis; a therapy that avoids these toxicities can give patients more freedom and less anxiety about delayed adverse events. ... Degevma was approved for skeletal-related events in adults with bone metastases, giant cell tumor of bone, and the treatment of hypercalcemia of malignancy. ... In the phase 3 EXCALIBER-RRMM trial, iberdomide plus daratumumab and dexamethasone doubled MRD-negative complete response rates over standard therapy in relapsed myeloma.

Original title: “Anito-Cel Delivers Durable Responses With Low Neurotoxicity in RRMM | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways”

HHS, through ARPA-H, launched a major effort to transform how clinical trials are designed and conducted through new SURPASS program. Beyond individual trials, these efforts are intended to create broadly useful tools, frameworks, and examples for the U.S. clinical trial ecosystem. Publicly available regulatory documents, validated standards, and real-world demonstrations of modernized trial methods could help sponsors, sites, regulators, and technology developers adopt more adaptive and efficient approaches across many diseases. The new Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program, together with three complementary projects announced today, aims to remove barriers that slow clinical development and help promising treatments reach patients sooner. Together, these efforts advance the Trump administration's work to modernize clinical development, reduce unnecessary delays and costs, and strengthen U.S. competitiveness in biotechnology and drug development. By making clinical trials faster, more efficient, and less burdensome for patients, ARPA-H aims to help promising treatments reach patients sooner while reinforcing the United States as a global leader in medical innovation. Create an agentic operations layer to reduce time and cost by automating key trial startup and operational activities, supporting onboarding of new treatment arms, and speeding data collection, cleaning, and dataset construction. To support this broader transformation of the U.S. clinical trial ecosystem, ARPA-H is also announcing three complementary projects that address critical infrastructure challenges beyond trial design itself:

Original title: “HHS Launches SURPASS and New Efforts to Accelerate Faster, Smarter Clinical Trials | HHS.gov”

essential oral single nutritional therapy products for inherited metabolic diseases evidence and consensus assessment using a modified delphi method

Original title: “Essential Oral Single Nutritional Therapy Products for Inherited Metabolic Diseases: Evidence and Consensus Assessment Using a Modified Delphi Method.”

psc dm a validated clinical diagnostic model for distinguishing primary from secondary sclerosing cholangitis

Original title: “PSC-DM: A Validated Clinical Diagnostic Model for Distinguishing Primary From Secondary Sclerosing Cholangitis.”

identification of prognostic factors and regulatory pathways in porto sinusoidal vascular disorder

Original title: “Identification of Prognostic Factors and Regulatory Pathways in Porto-Sinusoidal Vascular Disorder.”

rituximab with or without chemotherapy for anti mag neuropathy a retrospective multicenter real world study

Original title: “Rituximab With or Without Chemotherapy for Anti-MAG Neuropathy: A Retrospective Multicenter Real-World Study.”

A spokesperson confirmed that a “limited number” of liver-related safety events, including a patient death, were observed in testing of Bristol’s admilparant — though it’s unclear whether the drug was to blame.

Original title: “Bristol Myers trial revisions shake confidence in new class of fibrosis drugs”

The Myelofibrosis Clinical Trials analysis report delivers important insights into ongoing research on 50 pipeline Myelofibrosis Drugs clinical strategies upcoming therapeutics and commercial analysis Albany US September 30 2026 DelveInsight s Myelofibrosis Pipeline Insights 2026 report provides ... The Myelofibrosis Clinical Trials analysis report delivers important insights into ongoing research on 50 pipeline Myelofibrosis Drugs clinical strategies upcoming therapeutics and commercial analysis Albany US September 30 2026 DelveInsight s Myelofibrosis Pipeline Insights 2026 report provides comprehensive insights about ... It is currently being evaluated in a Phase II clinical trial for the treatment of Myelofibrosis. * RVU120: Ryvu Therapeutics RVU120 is an oral, selective inhibitor of CDK8 and CDK19, key regulators of transcriptional pathways involved in oncogenesis and inflammation. In Myelofibrosis, it modulates aberrant signaling such as STAT-driven pathways, helping to suppress malignant hematopoietic cell proliferation. The drug has demonstrated potential disease-modifying activity, including reduction of inflammatory cytokines and fibrosis-associated signaling. Press release - ABNewswire - Myelofibrosis Clinical Trial Drug Development Pipeline Expands with Contributions from 50+ Key Companies | DelveInsight - published on openPR.com To know in detail about the GLP-1 agonists market outlook [https://www.delveinsight.com/report-store/glucagon-like-peptide1-glp1-agonists-market-forecast?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=mpr], treatment uptake, and competitive landscape Some ... DelveInsight's, "Myelofibrosis Pipeline Insight 2024" report provides comprehensive insights about 35+ companies and 40+ pipeline drugs in Myelofibrosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type.

Original title: “Myelofibrosis Clinical Trial Drug Development Pipeline Expands with Contributions from 50+ Key Companies | DelveInsight”

The FDA previously hadn’t ever accepted an application of a drug like fenebrutinib in two major forms of MS. But safety questions still hang over Roche’s program.

Original title: “FDA starts review of Roche’s multiple sclerosis pill”

Ebvallo, which Pierre Fabre Pharmaceuticals and Atara Biotherapeutics are proposing to treat a posttransplant complication, joins a wave of rejected or discouraged therapies on which the FDA has reversed previous guidance after the exit of former Commissioner Marty Makary.

Original title: “Atara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again”

Of the 38 companies receiving incentives, 31 will expand outside of Boston and Cambridge. Still, Boston and Cambridge are each expected to gain over 200 jobs. Tax incentive award recipients include AstraZeneca, Bristol Myers Squibb and Insulet.

Original title: “$40M in tax incentives expected to generate 1,600+ life sciences jobs in Massachusetts”

A former congressman will take over for prominent lobbyist Steve Ubl. Elsewhere, recent buyout deals paid dividends for Mirum and AbbVie.

Original title: “PhRMA names next CEO; Pierre Fabre takes third swing at Ebvallo approval”

EloraTZP—a combination of an amylin asset and Eli Lilly’s approved obesity drug Zepbound—made a clean sweep of the primary and secondary endpoints in a mid-stage trial of adults with obesity and type 2 diabetes, setting up the launch of a Phase 3 trial before the end of the year.

Original title: “Superior weight loss, blood sugar control propel Lilly’s amylin-GIP/GLP-1 combo into Phase 3”

The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health.

Original title: “FDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees”

Eli Lilly’s weight loss pill Foundayo has had a “slower-than-hoped” launch, according to BMO Capital Markets, which contended that the indirect comparison data—despite falling short of definitive proof of superiority—could help the Indiana giant build momentum for its oral drug.

Original title: “Lilly builds commercial case for GLP-1 products over Novo with indirect analyses”