Noah AI Industry News

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

Merck's Subcutaneous Keytruda Approval: A Game-Changer in Cancer Treatment

In a significant development for the pharmaceutical industry, Merck & Co. has secured FDA approval for Keytruda Qlex, a subcutaneous version of its blockbuster cancer drug Keytruda. This approval marks a pivotal moment in oncology treatment, offering potential benefits for patients, healthcare providers, and Merck's market position.

NoahAI News9/23/2025

MapLight Therapeutics Files for IPO, Advancing Neuropsychiatric Drug Pipeline

MapLight Therapeutics, a California-based biotechnology company focused on developing treatments for neurological and psychiatric disorders, has filed for an initial public offering (IPO) with the U.S. Securities and Exchange Commission. The company aims to list on the Nasdaq under the ticker symbol "MPLT," potentially becoming only the second biotech to go public since February 2025.

NoahAI News9/23/2025

Patient Square Capital to Acquire Premier Inc. in $2.6B Deal, Taking Healthcare Group Private

Premier Inc., a prominent healthcare group purchasing organization and technology-enabled intelligence company, has agreed to a $2.6 billion acquisition by Patient Square Capital, a healthcare investment firm. The deal, announced on Monday, is set to take Premier private and is expected to close by the first quarter of 2026, subject to regulatory approvals and shareholder sign-offs.

NoahAI News9/23/2025

Johnson & Johnson's Tremfya Secures FDA Approval for Subcutaneous Use in Ulcerative Colitis, Marking a First for IL-23 Inhibitors

Johnson & Johnson (J&J) has achieved a significant milestone in the treatment of inflammatory bowel disease (IBD) with the recent FDA approval of Tremfya (guselkumab) for subcutaneous induction regimen in adults with moderately to severely active ulcerative colitis (UC). This approval, announced on September 22, 2025, positions Tremfya as the first IL-23 inhibitor to offer both intravenous (IV) and subcutaneous (subQ) dosing options from the start of treatment through maintenance therapy for IBD patients.

NoahAI News9/23/2025

Ionis Pharmaceutical's Zilganersen Shows Promise in Phase 3 Trial for Alexander Disease

Ionis Pharmaceuticals has announced positive results from a phase 1-3 trial of zilganersen, its antisense oligonucleotide candidate for the treatment of Alexander disease, a rare neurological condition. The trial demonstrated significant improvements in patient mobility, potentially paving the way for a new therapeutic option in this previously untreatable disorder.

NoahAI News9/23/2025

Medtronic's Altaviva Device Gains FDA Approval, Revolutionizing Urinary Incontinence Treatment

Medtronic, a leading medical technology company, has received Food and Drug Administration (FDA) approval for its innovative Altaviva device, designed to treat urge urinary incontinence. This breakthrough in neuromodulation therapy marks a significant advancement in the field of pelvic health and offers new hope for millions of patients struggling with bladder control issues.

NoahAI News9/23/2025

FDA Approves First Treatment for Barth Syndrome Amid Controversy

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Stealth BioTherapeutics' Forzinity (elamipretide), marking a significant milestone as the first-ever treatment for Barth syndrome, an ultra-rare genetic disorder affecting approximately 150 people in the United States.

NoahAI News9/23/2025

SS Innovations Expands Robotic Surgery's Reach with Affordable Technology

SS Innovations, a company founded by heart surgeon Sudhir Srivastava, is making significant strides in expanding access to robotic surgery globally. The company's SSi Mantra robot, designed to be more affordable and user-friendly than existing systems, has already been used in over 5,000 surgical procedures across seven countries.

NoahAI News9/23/2025

UnitedHealth Group Reshuffles Leadership at Optum Insight, Emphasizing AI in Healthcare

UnitedHealth Group has appointed Sandeep Dadlani as the new CEO of Optum Insight, marking another significant leadership change within the company's data and analytics division. This move underscores UnitedHealth's focus on leveraging artificial intelligence (AI) in healthcare and signals a continued reshuffling of its executive team.

NoahAI News9/23/2025

FDA Rejects Lundbeck and Otsuka's Rexulti for PTSD Treatment

The U.S. Food and Drug Administration (FDA) has issued a complete response letter to Lundbeck and Otsuka Pharmaceutical, denying approval for their atypical antipsychotic Rexulti (brexpiprazole) in combination with Viatris' Zoloft (sertraline) as a treatment for post-traumatic stress disorder (PTSD). The decision follows a negative recommendation from an FDA advisory committee earlier this year and marks a significant setback for the pharmaceutical partners in their efforts to expand Rexulti's indications.

NoahAI News9/23/2025

Glooko Expands into Inpatient Diabetes Care with Acquisition of Monarch Medical Technologies

Glooko, a leader in outpatient diabetes management platforms, has announced its acquisition of Monarch Medical Technologies, marking a significant expansion into the inpatient diabetes care market. The move brings Monarch's FDA-cleared EndoTool software under Glooko's umbrella, positioning the company to offer comprehensive diabetes management solutions across the entire care continuum.

NoahAI News9/23/2025

CVS Health's Omnicare Unit Files for Bankruptcy Amid Legal Challenges

CVS Health's long-term care pharmacy services provider, Omnicare, has initiated voluntary Chapter 11 bankruptcy proceedings in response to ongoing legal and financial challenges. The move comes as the company grapples with the fallout from a recent federal jury decision and a substantial court-ordered penalty.

NoahAI News9/23/2025

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