Daily biotech intelligence: FDA actions, drug recalls, and recent research.
BUSPIRONE HYDROCHLORIDE — Approved Sponsor: OXFORD PHARMS · Application type: ORIG · Date: 20020509
DEXTROMETHORPHAN POLISTIREX — Approved Sponsor: AUROBINDO PHARMA LTD · Application type: ORIG · Date: 20260415 · Priority: STANDARD
Unknown — Approved Sponsor: BIOCODEX SA · Application type: ORIG · Date: 20180820 · Priority: PRIORITY
ZOLEDRONIC ACID — Approved Sponsor: MYLAN LABS LTD · Application type: SUPPL · Date: 20230307 · Priority: STANDARD
USTEKINUMAB — Approved Sponsor: JANSSEN BIOTECH · Application type: SUPPL · Date: 20230306 · Priority: STANDARD
DUPIXENT (DUPILUMAB) — Approved Sponsor: REGENERON PHARMACEUTICALS · Application type: ORIG · Date: 20170328 · Priority: PRIORITY
Unknown — Tentative Approval Sponsor: HETERO LABS LTD V · Application type: ORIG · Date: 20260416 · Priority: STANDARD
COLESTIPOL HYDROCHLORIDE — Approved Sponsor: IMPAX LABS · Application type: SUPPL · Date: 20260415 · Priority: STANDARD
Fagron Compounding Services [Class II] — 20260415 Product: Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Servic Reason: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Fresenius Kabi USA, LLC [Class II] — 20260415 Product: 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex Reason: Lack of Assurance of Sterility
Fresenius Kabi USA, LLC [Class II] — 20260415 Product: 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL fre Reason: Lack of Assurance of Sterility
Teva Pharmaceuticals USA, Inc [Class II] — 20260415 Product: Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Cover Reason: CGMP Deviations: use of an unapproved raw material
Fresenius Kabi USA, LLC [Class II] — 20260415 Product: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex Reason: Lack of Assurance of Sterility
Mario Tuci, Caner Korkmaz, Umut Şimşekli · 2026-04-21 · cs.LG · cs.AI
Training modern neural networks often relies on large learning rates, operating at the edge of stability, where the optimization dynamics exhibit oscillatory and chaotic behavior. Empirically, this regime often yields improved generalization performance, yet the underlying mechanism remains poorly understood. In this work, we represent stochastic o
Simmaco Di Lillo, Leonardo Maini, Domenico Marinucci · 2026-04-21 · math.PR · cs.LG
We establish central and non-central limit theorems for sequences of functionals of the Gaussian output of an infinitely-wide random neural network on the d-dimensional sphere . We show that the asymptotic behaviour of these functionals as the depth of the network increases depends crucially on the fixed points of the covariance function, resulting
Austin Coursey, Abel Diaz-Gonzalez, Marcos Quinones-Grueiro · 2026-04-21 · cs.LG
Reinforcement learning (RL) offers a compelling data-driven paradigm for synthesizing controllers for complex systems when accurate physical models are unavailable; however, most existing control-oriented RL methods assume stationarity and, therefore, struggle in real-world non-stationary deployments where system dynamics and operating conditions c
Perry Dong, Alexander Swerdlow, Dorsa Sadigh · 2026-04-21 · cs.LG · cs.AI
Some of the most performant reinforcement learning algorithms today can be prohibitively expensive as they use test-time scaling methods such as sampling multiple action candidates and selecting the best one. In this work, we propose FASTER, a method for getting the benefits of sampling-based test-time scaling of diffusion-based policies without th
Abdulmoneam Ali, Ahmed Arafa · 2026-04-21 · cs.LG · cs.IT
Personalized Federated Learning (PFL) aims to learn multiple task-specific models rather than a single global model across heterogeneous data distributions. Existing PFL approaches typically rely on iterative optimization-such as model update trajectories-to cluster users that need to accomplish the same tasks together. However, these learning-dyna
Jean Mercat, Sedrick Keh, Kushal Arora · 2026-04-21 · cs.RO · cs.AI
We present VLA Foundry, an open-source framework that unifies LLM, VLM, and VLA training in a single codebase. Most open-source VLA efforts specialize on the action training stage, often stitching together incompatible pretraining pipelines. VLA Foundry instead provides a shared training stack with end-to-end control, from language pretraining to a
Jiaming Zhang, Meng Ding, Shaopeng Fu · 2026-04-21 · cs.LG · cs.AI
Despite the remarkable success of Vision Transformers (ViTs) across a wide range of vision tasks, recent studies have revealed that they remain vulnerable to adversarial examples, much like Convolutional Neural Networks (CNNs). A common empirical defense strategy is adversarial training, yet the theoretical underpinnings of its robustness in ViTs r
Jake Lee · 2026-04-21 · cs.LG · cs.AI
The discretization of continuous numerical attributes remains a persistent computational bottleneck in the induction of decision trees, particularly as dataset dimensions scale. Building upon the recently proposed MSD-Splitting technique -- which bins continuous data using the empirical mean and standard deviation to dramatically improve the effici
Opinion: Behind every miracle drug is a story (STAT News) “In every drug, there is a much larger story to tell about health and medicine and society and business and economics,” says Thomas Goetz.
Are MAHA snacks really better for you? Nutrition experts parse a grocery aisle gold rush (STAT News) From protein Pop-Tarts to avocado-oil chips, a MAHA-fueled snack revolution promises healthier eating. Experts say it may mostly be illusion.
Opinion: NASA’s plans for living in space should prioritize immunology and infectious disease (STAT News) Infectious diseases could pose serious risks for interplanetary travelers.
Opinion: The CDC’s ‘disease detective’ program turns 75 (STAT News) The CDC’s EIS program has trained more than 4,300 people to be the next generation of public health leaders.
STAT+: With successful trials, Roche takes its MS drug to regulators, but safety questions loom (STAT News) The Swiss drugmaker Roche presented the latest data for its experimental multiple sclerosis drug, setting the stage for the company to seek approval.
STAT+: From Revolution Medicines, more strong data on KRAS drug and a glimpse of a ‘novel class’ beyond it (STAT News) A company that is changing the outlook on pancreatic cancer has more promising data for treatments near-term and for a generation beyond.
STAT+: Kyverna Therapeutics plans to submit cell therapy for stiff person syndrome for FDA approval (STAT News) A one-time cell therapy from Kyverna Therapeutics for stiff person syndrome, a rare disease, improved mobility and reduced disabilities in a late-stage trial.
STAT+: At AACR, more strong results for Revolution Medicine’s KRAS drug, plus assurance from NCI’s director (STAT News) At AACR, Revolution Medicines presented more eye-catching data about its KRAS-targeting treatment, and Anthony Letai declared the state of cancer research steady.
STAT+: Key GOP senators push back on Trump’s plan to cut NIH, reorganize HHS (STAT News) Lawmakers seem poised to reject cuts to biomedical research and public health spending for a second straight year.
STAT+: Insurers refuse to join Medicare pilot offering weight loss drugs to seniors at steep discount (STAT News) Health insurers would have likely faced a financial strain by participating in the Medicare pilot.
Tortugas debuts with $106M and brain drugs from Hansoh, Eisai (BioPharma Dive) Led by former Sage Therapeutics executives Jeff Jonas and Al Robichaud, the company is starting out with a portfolio of neurological medicines in clinical testing.
Merck’s fast-ascending kidney cancer drug hits a setback (BioPharma Dive) Welireg’s failure in first-line kidney cancer removes a blockbuster opportunity and could leave an opening for a rival drug from Arcus Biosciences, analysts said.
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.