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Results For "Harvard-Medical-School"

21 News Found

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system
News | November 30, 2025

a2z wins FDA nod for groundbreaking abdomen-pelvis CT AI Triage system

Abdomen-pelvis CT is the nation’s highest-volume CT category


FDA updates label for Sun Pharma’s UNLOXCYT, highlighting durable responses in advanced skin cancer
Clinical Trials | November 27, 2025

FDA updates label for Sun Pharma’s UNLOXCYT, highlighting durable responses in advanced skin cancer

The update reflects long-term clinical trial data showing that many patients with mCSCC or laCSCC experienced lasting responses


Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'
Drug Approval | November 10, 2025

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases


AbbVie announces positive topline results from second Phase 3 UP-AA trial evaluating Upadacitinib
News | August 23, 2025

AbbVie announces positive topline results from second Phase 3 UP-AA trial evaluating Upadacitinib

The safety profile in alopecia areata was generally consistent with that in approved indications, and no new safety signals were identified in this study


AbbVie announces positive Phase 3 results for Upadacitinib in Alopecia Areata
Clinical Trials | August 06, 2025

AbbVie announces positive Phase 3 results for Upadacitinib in Alopecia Areata

The average baseline SALT score was 83.8, indicating about 16% scalp hair coverage


FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%
Drug Approval | July 15, 2025

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,


Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas
Drug Approval | January 19, 2025

Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas

This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo


Pfizer appoints Chris Boshoff as Chief Scientific Officer and President, Research & Development
People | November 21, 2024

Pfizer appoints Chris Boshoff as Chief Scientific Officer and President, Research & Development

Roger Dansey to become Interim Chief Oncology Officer and Johanna Bendell to join Pfizer as Oncology Chief Development Officer


Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure
Clinical Trials | September 02, 2024

Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure

Finerenone is the first mineralocorticoid receptor (MR) antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ?40%


Heuron gets FDA green light for stroke triage and notification solution
News | May 25, 2024

Heuron gets FDA green light for stroke triage and notification solution

This marks the first FDA approval of an AI-based brain disorder analysis solution from Korea