Daily biotech intelligence: FDA actions, drug recalls, and recent research.
CALCIPOTRIENE — Approved Sponsor: GLENMARK SPECLT · Application type: ORIG · Date: 20150609 · Priority: STANDARD
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG — Approved Sponsor: MARKSANS PHARMA · Application type: ORIG · Date: 20230929 · Priority: STANDARD
LAMOTRIGINE — Approved Sponsor: GLENMARK PHARMS LTD · Application type: SUPPL · Date: 20200210 · Priority: STANDARD
TZIELD (TEPLIZUMAB-MZWV) — Approved Sponsor: PROVENTION BIO INC · Application type: ORIG · Date: 20221117 · Priority: PRIORITY
Unknown — Approved Sponsor: IMPAX LABS · Application type: SUPPL · Date: 19910729
Unknown — Approved Sponsor: ALKEM LABORATORIES LIMITED · Application type: ORIG · Date: 20260421 · Priority: STANDARD
ZURZUVAE (ZURANOLONE) — Approved Sponsor: BIOGEN INC · Application type: SUPPL · Date: 20240731 · 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
Nicolae Filat, Ahmed Hussain, Konstantinos Kalogiannis · 2026-04-23 · cs.LG
Streaming Continual Learning (CL) typically converts a continuous stream into a sequence of discrete tasks through temporal partitioning. We argue that this temporal taskification step is not a neutral preprocessing choice, but a structural component of evaluation: different valid splits of the same stream can induce different CL regimes and theref
Paul-Tiberiu Iordache, Elena Burceanu · 2026-04-23 · cs.LG
Continual learning (CL) studies how models acquire tasks sequentially while retaining previously learned knowledge. Despite substantial progress in benchmarking CL methods, comparative evaluations typically keep the fine-tuning regime fixed. In this paper, we argue that the fine-tuning regime, defined by the trainable parameter subspace, is itself
Natalie Collina, Jiuyao Lu, Georgy Noarov · 2026-04-23 · cs.LG · math.ST
We study the minimax sample complexity of multicalibration in the batch setting. A learner observes $n$ i.i.d. samples from an unknown distribution and must output a (possibly randomized) predictor whose population multicalibration error, measured by Expected Calibration Error (ECE), is at most $\varepsilon$ with respect to a given family of groups
Pegah Khayatan, Jayneel Parekh, Arnaud Dapogny · 2026-04-23 · cs.CV · cs.AI
Despite impressive progress in capabilities of large vision-language models (LVLMs), these systems remain vulnerable to hallucinations, i.e., outputs that are not grounded in the visual input. Prior work has attributed hallucinations in LVLMs to factors such as limitations of the vision backbone or the dominance of the language component, yet the r
Bingcong Li, Yilang Zhang, Georgios B. Giannakis · 2026-04-23 · cs.LG · eess.SP
Low-rank adaptation (LoRA) has emerged as the de facto standard for parameter-efficient fine-tuning (PEFT) of foundation models, enabling the adaptation of billion-parameter networks with minimal computational and memory overhead. Despite its empirical success and rapid proliferation of variants, it remains elusive which architectural choices, opti
Max Defez, Filippo Quarenghi, Mathieu Vrac · 2026-04-23 · cs.LG · cs.AI
Deep-learning video super-resolution has progressed rapidly, but climate applications typically super-resolve (increase resolution) either space or time, and joint spatiotemporal models are often designed for a single pair of super-resolution (SR) factors (upscaling spatial and temporal ratio between the low-resolution sequence and the high-resolut
Sherly Alfonso-Sánchez, Cristián Bravo, Kristina G. Stankova · 2026-04-23 · stat.ML · cs.LG
Geographic context is often consider relevant to motor insurance risk, yet public actuarial datasets provide limited location identifiers, constraining how this information can be incorporated and evaluated in claim-frequency models. This study examines how geographic information from alternative data sources can be incorporated into actuarial mode
Jun Wang, Ziyin Zhang, Rui Wang · 2026-04-23 · cs.CL · cs.AI
Real-time detection and mitigation of technical anomalies are critical for large-scale cloud-native services, where even minutes of downtime can result in massive financial losses and diminished user trust. While customer incidents serve as a vital signal for discovering risks missed by monitoring, extracting actionable intelligence from this data
Growing use of guest editors has turned some journals into a ‘playground of bad science’ (STAT News) The problematic use of guest editors was spotlighted last week when a genetics journal retracted nearly an entire special issue.
Opinion: The local news crisis is also a public health crisis (STAT News) Health and science reporting is often treated as optional coverage. It is anything but.
Psychedelics get a boost from the White House (STAT News) In this week’s STATus Report, host Alex Hogan chats with STAT Washington correspondent Daniel Payne about Trump's psychedelics EO.
Opinion: I started medical school at 69 and will begin residency at 72. Here’s what I learned (STAT News) Starting residency at 72 isn’t for the faint of heart. But that’s what Dawn Zuidegeest-Craft is doing.
A CAR-T biotech’s dramatic turnaround, and drugmakers’ tactics to drive more scripts (STAT News) This week on "The Readout LOUD": a CAR-T biotech's dramatic turnaround, and drugmakers' tactics to drive more scripts. Listen now.
STAT+: Trump celebrates closing first round of drug pricing deals, promises more ahead (STAT News) A deal with Regeneron was the last of 17 initially sought by the White House.
Heart’s beat may help it beat cancer, mouse research suggests (STAT News) The constant pressure that the heart is under from beating thousands of times a day may create an environment hostile to cancers
STAT+: Trump’s boosting of psychedelics, cannabis signal a new era in GOP drug policy (STAT News) The Trump administration, in a stark departure from the "Just Say No" era, is funding psychedelics research and rescheduling marijuana.
STAT+: Legislatures in Colorado and Virginia resist moves to constrain drug affordability boards (STAT News) Legislators in two states are resisting efforts to restrict prescription drug affordability boards.
Opinion: Dropping the flu vaccine requirement puts U.S. military readiness at risk (STAT News) Since the 1918 pandemic, the military has acknowledged the threat of influenza. Now that’s changing.
FDA approves Regeneron’s hearing loss gene therapy (BioPharma Dive) Otarmeni, now cleared to treat a rare, inherited kind of hearing loss, is the first gene therapy cleared under the FDA’s “national priority” voucher program and will be offered to eligible patients at no cost.
Drugmaker AbbVie chooses North Carolina for $1.4B manufacturing campus (BioPharma Dive) The 185-acre site will be the company’s largest single investment to date, with a focus on small-volume parenteral products like vials and prefilled syringes.
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.