Daily biotech intelligence: FDA actions, drug recalls, and recent research.
LEUCOVORIN CALCIUM — Approved Sponsor: NOVAST LABS · Application type: SUPPL · Date: 20260505 · Priority: STANDARD
The Harvard Drug Group LLC [Class II] — 20260429 Product: Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
B BRAUN MEDICAL INC [Class II] — 20260429 Product: DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18 Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Leading Pharma, LLC [Class II] — 20260429 Product: Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Reason: CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Premier Dental Products Co [Class III] — 20260429 Product: Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Reason: Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (202
B BRAUN MEDICAL INC [Class II] — 20260429 Product: LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 1 Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Omar El Khalifi, Thomas Rossi, Oscar Fossey · 2026-05-07 · cs.CV · cs.AI
For artistic applications, video generation requires fine-grained control over both performance and cinematography, i.e., the actor's motion and the camera trajectory. We present ActCam, a zero-shot method for video generation that jointly transfers character motion from a driving video into a new scene and enables per-frame control of intrinsic an
Minbin Huang, Han Shi, Chuanyang Zheng · 2026-05-07 · cs.LG · cs.AI
Modern Mixture-of-Experts (MoE) architectures allocate expert capacity through a rigid per-layer rule: each transformer layer owns a separate expert set. This convention couples depth scaling with linear expert-parameter growth and assumes that every layer needs isolated expert capacity. However, recent analyses and our routing probe challenge this
Yuhang Lai, Jiazhan Feng, Yee Whye Teh · 2026-05-07 · cs.LG · cs.AI
Large Language Models (LLMs) demonstrate strong capabilities for solving scientific and mathematical problems, yet they struggle to produce valid, challenging, and novel problems - an essential component for advancing LLM training and enabling autonomous scientific research. Existing problem generation approaches either depend on expensive human ex
Jai Moondra, Ayela Chughtai, Bhargavi Lanka · 2026-05-07 · cs.LG · cs.DM
Ranking LLMs via pairwise human feedback underpins current leaderboards for open-ended tasks, such as creative writing and problem-solving. We analyze ~89K comparisons in 116 languages from 52 LLMs from Arena, and show that the best-fit global Bradley-Terry (BT) ranking is misleading. Nearly 2/3 of the decisive votes cancel out, and even the top 50
Yuxing Liu, Jianyu Wang, Tong Zhang · 2026-05-07 · cs.LG · cs.AI
Optimizers play an important role in both pretraining and finetuning stages when training large language models (LLMs). In this paper, we present an observation that full finetuning with the same optimizer as in pretraining achieves a better learning-forgetting tradeoff, i.e., forgetting less while achieving the same or better performance on the ne
Sushant Gautam, Finn Schwall, Annika Willoch Olstad · 2026-05-07 · cs.LG · cs.AI
Many deployments must compare candidate language models for safety before a labeled benchmark exists for the relevant language, sector, or regulatory regime. We formalize this setting as benchmarkless comparative safety scoring and specify the contract under which a scenario-based audit can be interpreted as deployment evidence. Scores are valid on
Zeyu Yang, Qi Ma, Jason Chen · 2026-05-07 · cs.IR · cs.AI
Retrieval-augmented agents are increasingly the interface to large organizational knowledge bases, yet most still treat retrieval as a black box: they issue exploratory queries, inspect returned snippets, and iteratively reformulate until useful evidence emerges. This approach resembles how a newcomer searches an unfamiliar database rather than how
Ivan Petej, Vladimir Vovk · 2026-05-07 · cs.LG
Venn-Abers predictors are probabilistic predictors that enjoy appealing properties of validity, but their major limitation is that they are applicable only to the case of binary classification, with a recent extension to bounded regression. We generalize them to the case of unbounded regression, which requires adding an element of conformal predict
Opinion: RFK Jr. allegedly ‘collected’ a dead raccoon’s penis. Was it bioethically justifiable? (STAT News) There are scientific reasons to study raccoon reproductive anatomy. But did RFK Jr.’s actions fit within a bioethical framework?
Opinion: Dr. Glaucomflecken wants the corporatization of medicine to be national news (STAT News) “We want, we need to keep medicine local. I think that's good for patients, it's good for communities,” Dr. Glaucomflecken says on the “First Opinion Podcast.”
Spain readies for evacuations as a hantavirus-hit cruise ship heads for the Canary Islands (STAT News) Spanish authorities on Friday were preparing to receive more than 140 passengers and crew members on board a hantavirus-stricken cruise ship headed for the Canary Islands.
STAT+: Roche to buy PathAI for $750 million (STAT News) Roche has signed a deal to acquire PathAI to speed up its use of artificial intelligence to help pathologists diagnose diseases.
Trump reportedly plans to fire FDA Commissioner Makary (STAT News) Makary's ouster would create another high-profile vacancy atop RFK Jr.'s health department.
STAT+: Capricor Therapeutics accuses Nippon Shinyaku of slow-walking plans on Duchenne drug (STAT News) Capricor Therapeutics has accused Nippon Shinyaku and its U.S. subsidiary of botching the rollout of a Duchenne muscular dystrophy treatment.
Opinion: I’m fighting misinformation online. False hantavirus claims follow a now-familiar playbook (STAT News) The cruise ship hantavirus outbreak is serious but limited. Online, it's another story.
Former FDA leaders, pharma speak out on mifepristone (STAT News) “The fundamental question is: Who gets to regulate mifepristone?”
STAT+: Up and down the ladder: The latest comings and goings (STAT News) From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
The biotechs wear Prada (STAT News) Was Naomi Osaka's Met Gala outfit inspired by Gilead's logo? Janelle Monáe's by Insilico's? Probably not — and yet.
FDA to reevaluate spurned cell therapy; Under-the-skin Leqembi review extended (BioPharma Dive) Pierre Fabre claims to now be “aligned” with U.S. regulators on the path forward for a twice-rejected treatment. Elsewhere, Argenx swapped CEOs and Blackstone made a $250 million biotech investment.
Lilly, Gilead lead pharma’s M&A boom (BioPharma Dive) Deal volume in 2026 is substantially outpacing last year, and activity is being driven by interest in cancer and autoimmune disease drugs.
This briefing is compiled automatically from FDA public APIs (openFDA), arXiv, and industry RSS feeds (STAT News, Fierce Biotech, BioPharma Dive, Nature, Science News). Not investment advice. Verify all data before making any decisions.