FDA Approvals News 11 August 2025

NeurAxis (NRXS) Stock Skyrockets on First-Ever FDA Approval for GI Pain Device

Recent FDA Approval and Market Reaction NeurAxis’s Oct. 24, 2025 announcement of FDA 510(k) clearance for its PENFS device immediately grabbed market attention. The clearance authorizes use in adults (8 years and

24 October 2025

Scienture Holdings (SCNX) Stock Skyrockets on FDA Drug Launch – Will the Rally Last?

Scienture Shares Skyrocket 350% on FDA-Approved Drug Launch – What’s Next?

Scienture’s unprecedented Oct. 23 rally was driven by the commercial rollout of Arbli, its first revenue-generating product. The company’s press release on Oct. 23 confirmed that it began sales and shipped first

24 October 2025

Company Analysis · FDA Approvals · Investment Trends · NASDAQ:SCNX · Pharma News · Stock Market

Scienture Holdings (SCNX) Stock Skyrockets on FDA Drug Launch – Will the Rally Last?

SCNX Stock Soars on Arbli Launch News Scienture’s stock has been on a rollercoaster in late October amid excitement over Arbli’s rollout. The initial catalyst came on October 16, 2025, when the

23 October 2025

FDA Approvals · Investment News · Market Trends · Pharmaceuticals · Stock Market

Replimune Stock Rockets 100% on FDA Nod – Analysts Eye Upside

Stock Performance and Recent Rally Replimune’s stock has been extremely volatile in 2025. It soared on Oct. 20 after the FDA acceptance news: shares nearly doubled from about $4.50 to $8.94 that

21 October 2025

Biotech News · FDA Approvals · Financial Markets · Investment Analysis · NASDAQ:REPL · Stock Market

Intuitive Surgical Stock Primed for Rally on FDA Approvals and Congressional Buying

Stock Performance & Analyst Consensus Intuitive’s stock has been volatile in 2025. It gained ground last week on optimism (e.g. up ~2.7% on Oct. 17) and now sits around $446 investing.com marketbeat.com.

19 October 2025

FDA Approvals · Healthcare Stocks · Investment Strategies · Medical Technology · NASDAQ:ISRG · Stock Market

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%

18 October 2025

Biotech · FDA Approvals · Investment · NASDAQ:ATAI · Pharma News · Stock Market

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

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

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

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

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

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

11 August 2025

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

FDA Approvals News 11 August 2025 - 24 October 2025