Noah AI Industry News

Delivers real-time biopharma news and signals — powered by AI, curated for professionals.

FDA Revives Dormant Drug for Autism Treatment, Warns of Acetaminophen Risks in Pregnancy

In a significant move, the U.S. Food and Drug Administration (FDA) has initiated the reapproval process for GlaxoSmithKline's (GSK) Wellcovorin, a drug that has been off the market for 25 years, as a potential treatment for autism symptoms. Simultaneously, the agency has raised concerns about the use of acetaminophen during pregnancy, linking it to possible neurological and developmental defects in children.

NoahAI News9/24/2025

Lexicon Pharmaceuticals Faces Further Delays in Type 1 Diabetes Drug Approval

Lexicon Pharmaceuticals has encountered another setback in its pursuit of regulatory approval for Zynquista, its oral medication designed to improve glycemic control in patients with type 1 diabetes. The U.S. Food and Drug Administration (FDA) has requested additional time to review the company's latest submissions, pushing the timeline for feedback into the fourth quarter of 2025.

NoahAI News9/24/2025

Ionis Pharmaceuticals' Zilganersen Shows Promise in Rare Neurological Disease Trial

Ionis Pharmaceuticals has announced positive results from a pivotal Phase I-III study of zilganersen, an investigational antisense oligonucleotide therapy for Alexander disease (AxD), a rare and often fatal neurological condition. The study's success paves the way for a potential FDA submission, marking a significant milestone in the treatment of this devastating disorder.

NoahAI News9/24/2025

Bristol Myers Squibb's Iberdomide Shows Promise in Key Multiple Myeloma Study

Bristol Myers Squibb (BMS) has announced positive interim results from a pivotal Phase 3 clinical trial of iberdomide, a next-generation blood cancer drug positioned to succeed the company's blockbuster franchises Revlimid and Pomalyst. The study, known as Excaliber-RRMM, evaluated iberdomide in combination with Darzalex and dexamethasone for patients with relapsed or refractory multiple myeloma.

NoahAI News9/24/2025

FDA Initiates Unusual Repurposing of Old GSK Drug for Autism Treatment

In an unprecedented move, the U.S. Food and Drug Administration (FDA) has announced plans to approve GSK's long-discontinued drug leucovorin, formerly marketed as Wellcovorin, for the treatment of cerebral folate deficiency associated with autism. This decision, part of the Trump administration's efforts to combat autism, marks a significant departure from traditional drug approval processes.

NoahAI News9/24/2025

Qventus Unveils 'AI Solution Factory' to Accelerate Healthcare AI Implementation

Qventus, a leader in healthcare artificial intelligence, has announced the launch of its "AI Solution Factory," a new capability designed to dramatically accelerate the deployment of AI solutions in healthcare settings. This innovative approach promises to bring a wider range of AI-powered tools to health systems more rapidly than ever before, while maintaining a focus on depth and return on investment.

NoahAI News9/24/2025

FDA Rejects Scholar Rock's SMA Drug Due to Manufacturing Concerns

Scholar Rock's bid to introduce the first muscle-targeted treatment for spinal muscular atrophy (SMA) has hit a significant roadblock. The U.S. Food and Drug Administration (FDA) has rejected the company's application for apitegromab, citing manufacturing issues at a third-party facility.

NoahAI News9/24/2025

RevSpring to Acquire Kyruus Health, Uniting Patient Engagement and Provider Search Solutions

RevSpring, a leading health tech company specializing in patient engagement and payment solutions, has announced its agreement to acquire Kyruus Health. This strategic move aims to combine RevSpring's patient communication and payment technology with Kyruus' provider data, search, and scheduling solutions. The acquisition, expected to close in the fourth quarter, promises to create a unified platform that streamlines the patient journey from initial provider search to final payment.

NoahAI News9/24/2025

Sanofi Injects $625M into Biotech Venture Arm, Eyeing Innovation Amid Funding Crunch

French pharmaceutical giant Sanofi has announced a significant boost to its venture capital operations, infusing $625 million into Sanofi Ventures. This strategic move aims to capitalize on the current biotech landscape, which is rich in scientific innovation but facing a capital shortage.

NoahAI News9/24/2025

Rome Therapeutics Faces Uncertain Future Amid Layoffs and Strategic Review

Boston-based preclinical biotech Rome Therapeutics is navigating turbulent waters as it announces significant restructuring measures. The company, known for its innovative approach to targeting the "dark genome," is implementing layoffs, evaluating strategic options, and transitioning to a fully virtual model in response to challenging market conditions.

NoahAI News9/24/2025

Moderna's Updated COVID-19 Vaccine Shows Promise Against New Variant

Moderna, a leading pharmaceutical company, has announced promising early results for its next-generation COVID-19 vaccine, mNEXSPIKE. The updated formula demonstrates a strong immune response against the latest rapidly spreading SARS-CoV-2 virus variant, potentially offering enhanced protection for vulnerable populations.

NoahAI News9/23/2025

Seres Therapeutics Announces Layoffs and Strategic Shift to Fund Phase 2 Study

Seres Therapeutics, a prominent microbiome biopharma company, has announced a significant restructuring effort aimed at conserving resources for its upcoming phase 2 study of SER-155, a promising treatment for preventing bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant.

NoahAI News9/23/2025

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