Daily biotech intelligence: FDA actions, drug recalls, and recent research.
Unknown — Approved Sponsor: KING PHARMS LLC · Application type: SUPPL · Date: 19950822 · Priority: STANDARD
SILIQ (BRODALUMAB) — Approved Sponsor: VALEANT LUXEMBOURG · Application type: SUPPL · Date: 20260507 · Priority: N/A
Unknown — Approved Sponsor: TEVA · Application type: SUPPL · Date: 20260507 · Priority: STANDARD
HYDROCORTISONE SODIUM SUCCINATE — Approved Sponsor: ZYDUS PHARMS · Application type: ORIG · Date: 20260507 · Priority: STANDARD
Unknown — Approved Sponsor: I3 PHARMS · Application type: ORIG · Date: 20260507 · Priority: STANDARD
Unknown — Approved Sponsor: MICRO LABS · Application type: ORIG · Date: 20260507 · Priority: STANDARD
Unknown — Tentative Approval Sponsor: LACHMAN CONSULTANT SERVICES , INC. · Application type: ORIG · Date: 20260507 · Priority: STANDARD
Unknown — Approved Sponsor: TEVA PHARMS · Application type: SUPPL · Date: 20100513
BRILINTA (TICAGRELOR) — Approved Sponsor: ASTRAZENECA · Application type: SUPPL · Date: 20130329 · Priority: STANDARD
Thea Pharma, Inc. [Class II] — 20260506 Product: Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Wells Pharma of Houston LLC [Class II] — 20260506 Product: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Reason: cGMP deviations.
Thea Pharma, Inc. [Class II] — 20260506 Product: iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Wells Pharma of Houston LLC [Class II] — 20260506 Product: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well ph Reason: cGMP deviations.
Wells Pharma of Houston LLC [Class II] — 20260506 Product: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg p Reason: cGMP deviations.
Tara Bogavelli, Gabrielle Gauthier Melançon, Katrina Stankiewicz · 2026-05-13 · cs.SD · cs.AI
Voice agents, artificial intelligence systems that conduct spoken conversations to complete tasks, are increasingly deployed across enterprise applications. However, no existing benchmark jointly addresses two core evaluation challenges: generating realistic simulated conversations, and measuring quality across the full scope of voice-specific fail
Steve Hanneke, Anay Mehrotra, Grigoris Velegkas · 2026-05-13 · stat.ML · cs.DS
Valiant's 1984 paper is widely credited with introducing the PAC learning model, but it, in fact, introduced a different model: unlike PAC learning, the learner receives only positives, may issue membership queries, and must output a hypothesis with no false positives. Prior work characterized variants, including the case without queries. We revisi
Zijie Wu, Lixin Xu, Puhua Jiang · 2026-05-13 · cs.CV · cs.GR
Video-guided 3D animation holds immense potential for content creation, offering intuitive and precise control over dynamic assets. However, practical deployment faces a critical yet frequently overlooked hurdle: the pose misalignment dilemma. In real-world scenarios, the initial pose of a user-provided static mesh rarely aligns with the starting f
Dongzhe Zheng, Tao Zhong, Christine Allen-Blanchette · 2026-05-13 · cs.LG · cs.AI
In this paper, we study solution operators of physical field equations on geometric meshes from a function-space perspective. We reveal that Hodge orthogonality fundamentally resolves spectral interference by isolating unlearnable topological degrees of freedom from learnable geometric dynamics, enabling an additive approximation confined to struct
Hoang-Quan Nguyen, Sankalp Pandey, Khoa Luu · 2026-05-13 · cs.LG · cs.CV
Modeling long-range dependencies in sequential data remains a central challenge in machine learning. Transformers address this challenge through attention mechanisms, but their quadratic complexity with respect to sequence length limits scalability to long contexts. State-space models (SSMs) provide an efficient alternative with linear-time computa
S. Akshay, Chaitanya Garg, Ashutosh Gupta · 2026-05-13 · cs.AI · cs.LG
Decision tree ensembles (DTE) are a popular model for a wide range of AI classification tasks, used in multiple safety critical domains, and hence verifying properties on these models has been an active topic of study over the last decade. One such verification question is the problem of sensitivity, which asks, given a DTE, whether a small change
Harry Mayne, Lev McKinney, Jan Dubiński · 2026-05-13 · cs.CL · cs.AI
We introduce Negation Neglect, where finetuning LLMs on documents that flag a claim as false makes them believe the claim is true. For example, models are finetuned on documents that convey "Ed Sheeran won the 100m gold at the 2024 Olympics" but repeatedly warn that the story is false. The resulting models answer a broad set of questions as if Shee
Gordan Prastalo, Kevin Maik Jablonka · 2026-05-13 · cs.LG · cond-mat.mtrl-sci
Scientific machine learning reports predictive performance. It does not report whether the same prediction would survive a different draw of training data. Across $9$ chemistry benchmarks, two classifiers trained on independent bootstraps of the same training set agree on aggregate accuracy to within $1.3\text{--}4.2$ percentage points but disagree
STAT+: Biogen’s tau-targeting Alzheimer’s drug posts mixed results in mid-stage study (STAT News) Biogen is moving its tau-targeting Alzheimer's drug into Phase 3 studies, despite mixed data from a Phase 2 trial.
STAT+: Regenxbio says Duchenne gene therapy succeeded in clinical trial, paving way for FDA submission (STAT News) Regenxbio said its experimental gene therapy for Duchenne muscular dystrophy succeeded in a trial, paving the way for a submission to the FDA.
STAT+: CREATE Medicines, a biotech company developing CAR-T therapies, raises $122 million (STAT News) CREATE Medicines has a new name, an expanded pipeline, and now fresh funding to propel the company’s first CAR-T candidates through human trials.
STAT+: ‘No drama’ Diamantas should serve biotech well as acting FDA chief (STAT News) Kyle Diamantas, the acting commissioner of the FDA, is expected to be a drama-free, stabilizing caretaker at the top of the agency.
Opinion: Using AI in addiction medicine could be particularly risky (STAT News) "AI can make great strides in medical decision support, but unfiltered interaction between agent and patient is dangerous," writes Steve D. Klein.
STAT+: Treatment for alcohol addiction is undergoing a seismic shift. Many say it’s overdue (STAT News) The surging popularity of alternatives to Alcoholics Anonymous represents a seismic shift in the alcohol treatment landscape. Many say it's overdue.
Hantavirus risk remains low, CDC says, citing its ‘playbook’ response (STAT News) Despite rising concern about the hantavirus outbreak on a cruise ship, two CDC doctors say the risk to the public remains low.
Officials say $1.3 billion in Medicaid money to California will be deferred over suspicions of fraud (STAT News) Vice President JD Vance announced a $1.3 billion deferral in Medicaid reimbursements to California, as part of an initiative to root out fraud in federal health programs.
Opinion: The hantavirus is a wake-up call. Will the Trump administration answer it? (STAT News) Arriving in the isolation ward of a biocontainment hospital is an unsettling, scary experience. In 2014, I spent 19 days in one while being treated for Ebola, watching the news…
Opinion: Hospitals are silencing doctors online, and it’s fueling the health misinformation crisis (STAT News) Hospitals and health systems need to loosen the reins and let physicians combat social media misinformation, writes Adam Goodcoff.
FDA’s leadership void leaves biotech with renewed ‘uncertainty’ (BioPharma Dive) Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.
Lilly data point to ‘maintenance’ strategies for GLP-1 weight loss (BioPharma Dive) A pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could help people with obesity keep their weight down over the long term.
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.