Noah AI Industry News

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

FDA Delays Decision on Ascendis' Dwarfism Drug, TransCon CNP

FDA Delays Decision on Ascendis' Dwarfism Drug, TransCon CNP

The U.S. Food and Drug Administration (FDA) has extended its review period for Ascendis Pharma's dwarfism drug candidate, TransCon CNP, pushing the decision deadline from November 30, 2025, to February 28, 2026. This three-month delay comes as the agency requires additional time to review recently submitted information regarding post-marketing requirements.

NoahAI News11/27/2025
Ceribell Expands Seizure Detection Capabilities with FDA Clearance for Neonates

Ceribell Expands Seizure Detection Capabilities with FDA Clearance for Neonates

Ceribell, a leading medical technology company, has received FDA clearance for its Clarity algorithm to detect electrographic seizures in preterm infants, expanding its capabilities across all age groups. This development marks a significant advancement in neonatal care and seizure management.

NoahAI News11/27/2025
HHS Rehires 954 Workers Laid Off During Government Shutdown

HHS Rehires 954 Workers Laid Off During Government Shutdown

In a significant development for the U.S. Department of Health and Human Services (HHS), all 954 employees who were laid off during the October government shutdown have been reinstated. This move comes as part of a broader trend of workforce fluctuations within the agency, raising questions about the stability of federal employment and the use of layoffs as a political tactic.

NoahAI News11/27/2025
ARPA-H Launches Ambitious Program for Autonomous Surgical Robots with Focus on Stroke Treatment

ARPA-H Launches Ambitious Program for Autonomous Surgical Robots with Focus on Stroke Treatment

The Advanced Research Projects Agency for Health (ARPA-H) has unveiled a groundbreaking funding initiative aimed at developing autonomous robotic systems for medical interventions, with a particular emphasis on stroke treatment. This program seeks to revolutionize healthcare delivery by extending advanced surgical capabilities beyond traditional hospital settings.

NoahAI News11/27/2025
AstraZeneca's Imfinzi Breaks New Ground in Gastric Cancer Treatment

AstraZeneca's Imfinzi Breaks New Ground in Gastric Cancer Treatment

AstraZeneca has secured a significant victory in the field of oncology with the FDA's approval of Imfinzi for the treatment of gastric and gastroesophageal junction (GEJ) cancers. This landmark decision marks Imfinzi as the first immunotherapy approved for perioperative use in these types of cancers, potentially revolutionizing treatment approaches for patients with resectable tumors in stages II through IVA.

NoahAI News11/26/2025
FDA Delays Decision on Ascendis Pharma's Dwarfism Drug, Impacting Competitive Landscape

FDA Delays Decision on Ascendis Pharma's Dwarfism Drug, Impacting Competitive Landscape

The U.S. Food and Drug Administration (FDA) has extended its review period for Ascendis Pharma's dwarfism drug candidate, TransCon CNP, pushing the decision deadline from November 30, 2025, to February 28, 2026. This three-month delay comes as the agency requires additional time to review recently submitted information regarding post-marketing requirements.

NoahAI News11/26/2025
Premier Closes $2.6B Take-Private Deal with Patient Square Capital

Premier Closes $2.6B Take-Private Deal with Patient Square Capital

Premier, a leading healthcare services and group purchasing organization, has officially gone private in a $2.6 billion acquisition by Patient Square Capital, a healthcare-focused investment firm. The deal, which closed earlier than anticipated on November 26, 2025, marks the end of Premier's decade-long run as a public company on the Nasdaq stock exchange.

NoahAI News11/26/2025
FDA Roadmap Paves Way for New Approach Methodologies in Preclinical Safety Studies

FDA Roadmap Paves Way for New Approach Methodologies in Preclinical Safety Studies

The U.S. Food and Drug Administration (FDA) has released a groundbreaking roadmap aimed at reducing animal testing in preclinical safety studies, signaling a significant shift towards New Approach Methodologies (NAMs). This initiative, coupled with a coordinated national effort involving multiple stakeholders, is set to transform the landscape of drug development and toxicology testing.

NoahAI News11/26/2025
Novartis Expands SMA Treatment Options with FDA Approval of Itvisma Gene Therapy

Novartis Expands SMA Treatment Options with FDA Approval of Itvisma Gene Therapy

Novartis has secured a significant victory in the treatment of spinal muscular atrophy (SMA) with the U.S. Food and Drug Administration's approval of Itvisma, an intrathecal version of its gene therapy Zolgensma. This groundbreaking development expands treatment options for older SMA patients, marking a pivotal moment in the field of genetic medicine.

NoahAI News11/26/2025
Medtronic Appoints Jim Peichel as New Chief Technology Officer

Medtronic Appoints Jim Peichel as New Chief Technology Officer

Medtronic, a global leader in medical technology, has announced the appointment of Jim Peichel as its new Chief Technology Officer (CTO). This strategic move comes as part of the company's ongoing efforts to advance innovation and technological development in the medical device industry.

NoahAI News11/26/2025
Avidity Secures $12B Acquisition Deal with Novartis After Months of Tough Negotiations

Avidity Secures $12B Acquisition Deal with Novartis After Months of Tough Negotiations

In a significant development for the pharmaceutical industry, Avidity Biosciences has successfully negotiated a $12 billion acquisition deal with Novartis, following a series of intense negotiations that spanned several months. The deal, announced on October 26, marks a major milestone for both companies and highlights the growing interest in innovative therapies for rare diseases.

NoahAI News11/26/2025
Pharmaceutical Industry Faces Continued Restructuring and Layoffs Amid Strategic Shifts

Pharmaceutical Industry Faces Continued Restructuring and Layoffs Amid Strategic Shifts

Novartis has unveiled plans for significant manufacturing changes that will impact hundreds of jobs across its global operations. The Swiss pharmaceutical giant will eliminate 550 positions at its Stein, Switzerland facility by the end of 2027 as it discontinues production and packaging of tablets and capsules at the site. This move comes as part of a $26 million automation overhaul aimed at boosting productivity.

NoahAI News11/26/2025
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