FDA Approvals News 17 July 2025

ATAI Life Sciences Skyrockets on FDA Breakthrough and $130M Cash Infusion

Key Facts – October 18, 2025 Stock Soars on Breakthrough News and Funding Boost ATAI’s stock price surged in the last few days amid a flurry of good news. Shares jumped 17.7% on Friday (Oct 17) alone, finishing at $6.45

18 October 2025

Artiva Biotherapeutics (ARTV) Stock Skyrockets on FDA Fast Track News – What’s Next for Investors?

In summary, Artiva Biotherapeutics stock has erupted in October 2025 on the back of a major FDA Fast Track win and renewed optimism around its NK-cell therapy for RA. The latest developments – from surging share price and volume to

17 October 2025

Biotech News · FDA Approvals · Financial Analysis · Investment Strategies · NASDAQ:ARTV · Stock Market

Femasys (FEMY) Stock Soars 46% on Fertility Tech and FDA Milestones

Femasys’ stock surge on Oct. 16 mirrors growing investor interest in its reproductive healthcare pipeline. The company’s FemaSeed™ technology is designed to boost pregnancy rates by delivering sperm directly into the fallopian tube, and published trials report more than double the pregnancy

16 October 2025

FDA Approvals · Fertility Technology · Healthcare Innovation · Investment News · NASDAQ:FEMY · Stock Market

Scienture (SCNX) Stock Skyrockets on New FDA-Approved Blood Pressure Drug Launch

SCNX Stock Climbs on Arbli Launch Pills and a daily pill organizer: Arbli’s liquid formulation helps patients (especially children/elderly) who can’t swallow tablets. Scienture’s stock jumped sharply on Oct. 16 after the company formally launched Arbli™ in the U.S. market.

16 October 2025

Biotech News · FDA Approvals · Investment Insights · Pharmaceuticals · Stock Market

Spruce Biosciences Skyrockets on FDA Breakthrough – Will SPRB’s Rally Last or Fade?

Stock Performance & Recent Price Action Spruce Biosciences’ stock has been on a wild ride in early October 2025. Heading into this period, SPRB was a little-known micro-cap biotech trading in the high single digits (post-reverse-split). At the close on

6 October 2025

Biotech · FDA Approvals · Health News · Investing · NASDAQ:SPRB · Stock Market

Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

Stock Performance and Trends Sarepta’s stock is recovering some ground after steep losses. As of Oct 2, 2025, SRPT closed at $19.57, up about 6.8%for the day investing.com. This followed a general uptrend in recent weeks: SRPT is up roughly 16% over the last

2 October 2025

Biotech · FDA Approvals · Gene Therapy · NASDAQ:SRPT · Pharmaceuticals · Stock Analysis · Stock Market

Breakthrough Trials, FDA Greenlights & Global Health Alerts: Biotech & Health News (Aug 10–11, 2025)

Novartis announced that two Phase III trials, NEPTUNUS-1 and NEPTUNUS-2, met their primary endpoints in Sjögren’s disease, marking the first global Phase III evidence of significant disease activity reduction with ianalumab and its dual B-cell depletion and BAFF signaling blockade.

11 August 2025

Biotech News · FDA Approvals · Global Health · Health Alerts · Medical Research

Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

Drug Approvals & Regulatory Developments (In Europe, regulators also made news: the EMA’s committee recommended approving darolutamide (Bayer’s Nubeqa) with hormone therapy for metastatic prostate cancer based on positive Phase 3 data onclive.com.) Clinical Trials & Research Breakthroughs Public Health

9 August 2025

Biotechnology · FDA Approvals · Global Health · Healthcare News · Medical Innovations · NASDAQ:BLUE · NYSE:TMO

AI Pathology Breakthrough: Roche’s Lung Cancer Diagnostic Makes FDA History

In April 2025, Roche’s Ventana TROP2 (EPR20043) RxDx test became the first AI-powered diagnostic to receive FDA Breakthrough Device Designation. The device pairs an immunohistochemistry stain for TROP2 with a digital pathology AI algorithm that runs in Roche’s Navify system

17 July 2025

AI in Healthcare · FDA Approvals · Medical Diagnostics · NYSE:AZN · NYSE:RHHBY · Oncology · Technological Innovation

FDA Approvals News 17 July 2025 - 18 October 2025