1. EU committee recommends daraxonrasib for previously treated metastatic pancreatic cancer
Europe moves to follow the FDA on a first-in-class RAS inhibitor that nearly doubled median survival versus chemotherapy.
The EMA's CHMP recommended marketing authorization for Rasonque (daraxonrasib) in adults with metastatic pancreatic adenocarcinoma who have had at least one prior treatment, naming it a high-priority medicine under the agency's Cancer Medicines Pathfinder [1][2][3]. In the 500-patient RASolute 302 trial, median overall survival was 13.2 versus 6.7 months; the European Commission makes the final call [2]. (See lead article.)
2. HHS and FDA send a peptide compounding "interim access policy" to the White House
A policy that could ease pharmacy compounding of unapproved peptides such as BPC-157 is now under White House review.
HHS and the FDA submitted an "interim access policy for compounding using certain peptides" for review on October 15, according to an Office of Management and Budget filing that gives no details of the policy [4]. Two people familiar with the plan told the AP it would let pharmacies temporarily compound some popular peptides, including BPC-157, which the FDA had previously placed on its list of substances too risky to compound [5]. The peptides under consideration have not been approved by the FDA as safe or effective; in July, outside advisers recommended loosening restrictions on six of seven peptides reviewed, against the conclusions of FDA staff scientists [4][5][6]. HHS did not immediately respond to requests for comment [4][5].
3. EU committee backs Lilly's once-daily GLP-1 pill and five other new medicines
Orforglipron (Foundayo) won a positive CHMP opinion for obesity and type 2 diabetes in adults.
At its October 12–15 meeting, the CHMP recommended six new medicines, including Foundayo (orforglipron), an oral GLP-1 receptor agonist taken as a once-daily tablet, and Yuviwel (navepegritide) for achondroplasia in children [1][7]. On re-examination, the committee confirmed its recommendation to refuse authorization for Omeros' Yartemlea (narsoplimab) for transplant-associated thrombotic microangiopathy [1]. CHMP opinions are recommendations; the European Commission issues the final decisions [2].
4. Par Health recalls 22 lots of argatroban injection over particulate matter
The IV blood thinner recall is Par's third U.S. product pull in about a month.
Par Health is recalling 22 lots of argatroban injection 250 mg/2.5 mL after finding particles identified as cellulose, polystyrene, polyethylene terephthalate, stopper material and possibly stainless steel; the company says injected particulates could cause life-threatening problems including pulmonary emboli [8]. The lots were shipped nationwide to wholesalers and hospitals, and Par says it has received no reports of related adverse events [8]. Fierce Pharma reports that earlier recalls covered dexmedetomidine (September 18) and Brevital (methohexital) (October 8) [9].
Digest references
European Medicines Agency. "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12–15 October 2026." EMA, October 16, 2026. Link
Revolution Medicines. "RASONQUE (daraxonrasib) Receives Positive CHMP Opinion Recommending Marketing Authorization in European Union for Metastatic Pancreatic Cancer." Press release, October 15, 2026. Link
Keshavan M, Joseph A. "RevMed's pancreatic cancer drug nears European approval." STAT, October 16, 2026. Link
Reuters. "US FDA takes step to change peptide compounding policy." Reuters (syndicated by WMBD), October 15, 2026. Link
Associated Press. "Trump administration advances plan for peptide drugs favored by RFK Jr." STAT, October 15, 2026. Link
KFF Health News. "Morning Briefing: Trump Administration Pushes Peptide Drugs Backed By RFK Jr." KFF Health News, October 16, 2026. Link
Brown A. "CHMP endorses Eli Lilly's GLP-1 pill and three other new drugs." Endpoints News, October 16, 2026. Link
Par Health. "Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to Presence of Particulate Matter." Company announcement posted by FDA, October 14, 2026. Link
Fierce Pharma. "Par Health recalls 22 lots of IV blood thinner, its 3rd US product pull in a month." Fierce Pharma, October 15, 2026. Link
