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FDA Approvals News 17 July 2025 - 16 October 2025

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

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 rate of traditional intrauterine inseminationglobenewswire.comstocktitan.net. Femasys is positioning FemaSeed as a first-line, lower-cost infertility option ahead of IVF. Meanwhile, FemBloc offers a first-of-its-kind permanent birth control that creates a natural scar in the fallopian tubes, avoiding surgeryir.femasys.comir.femasys.com. This week’s ASRM announcement – coinciding with broader fertility news – helped lift FEMY. Also on Oct. 16, national media reported an expected US policy to expand IVF
16 October 2025
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Scienture (SCNX) Stock Skyrockets on New FDA-Approved Blood Pressure Drug Launch

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. In a GlobeNewswire press release that morning, Scienture announced that Arbli™ is now shipping through major pharmaceutical wholesalers nationwideglobenewswire.com. Arbli is the first FDA-approved oral liquid form of losartan, a top-selling blood pressure drug. The launch news and accompanying marketing caused traders to bid up SCNX: one trader wrote that shares moved “from yesterday’s close around 72 cents to nearly
16 October 2025
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Spruce Biosciences Skyrockets on FDA Breakthrough – Will SPRB’s Rally Last or Fade?

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 Oct 3, 2025, shares stood at $8.82 (market cap ~$4.8M)stocktitan.net after a period of relatively low activity. That calm shattered on Oct 6, when news of an FDA breakthrough designation sent the stock skyrocketing. SPRB opened the day with a huge gap up and at one point surged by 250–300% intraday, hitting roughly $31–$32 per sharebenzinga.comstocktwits.com. Benzinga reported Spruce trading
6 October 2025
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Sarepta Therapeutics (SRPT) Surges After FDA Greenlights Duchenne Gene Therapy – Is a Rebound Ahead?

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 month marketbeat.com (though still down >80% from early 2025 levels). Trading volume has been moderate (0.6 million on Oct 2 vs. ~5–9M in prior days) investing.com. Over five trading days it gained +14.6% marketbeat.com, reflecting renewed investor interest. By contrast, the stock had sunk to ~$10–12 in mid-2025 amid safety concerns. Year-to-date, SRPT’s performance is dismal: a –82% return in one year marketbeat.com,
2 October 2025
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Breakthrough Trials, FDA Greenlights & Global Health Alerts: Biotech & Health News (Aug 10–11, 2025)

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. IO Biotech will disclose topline results from its Phase III melanoma trial of Cylembio (IO102-IO103) in combination with Merck’s Keytruda (pembrolizumab) as a first-line therapy, with an August 11 webcast planned and the therapy having earned Breakthrough Therapy designation. GSK’s gepotidacin received Priority Review from the U.S. FDA for uncomplicated gonorrhea, with a decision expected by December and the potential
11 August 2025
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Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)

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 & Policy Industry & Business Updates Sources: Key information and quotes in this report were drawn from Reuters news wires reuters.com reuters.com, official WHO releases who.int pharmabiz.com, and industry trade outlets including Fierce Biotech/Pharma fiercepharma.com fiercepharma.com and company statements. Each development is linked to its original source for further reading.
9 August 2025
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AI Pathology Breakthrough: Roche’s Lung Cancer Diagnostic Makes FDA History

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 to analyze NSCLC biopsy slides. The AI calculates a Normalized Membrane Ratio (NMR), the ratio of surface TROP2 to internal TROP2, to classify tumors as TROP2-positive or -negative. The Ventana TROP2 RxDx is a full diagnostic system, including Roche’s slide scanners, the Navify image management software, the Ventana TROP2 IHC kit, and the AI algorithm. A positive NMR score thresholds
17 July 2025
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Stock Market Today

CrowdStrike stock jumps nearly 5% after Aramco pact — what investors watch next

CrowdStrike stock jumps nearly 5% after Aramco pact — what investors watch next

7 February 2026
CrowdStrike shares jumped 4.8% to $395.50 after the company announced a non-binding memorandum of understanding with Saudi Aramco. The move ended a seven-session losing streak for the stock, which remains about 30% below its 52-week high. Investors await more details on the Aramco talks and CrowdStrike’s March 3 earnings report. Trading volume topped 4.9 million shares, well above average.
Visa stock price edges up as Visa & Main rolls out — what’s next for NYSE:V

Visa stock price edges up as Visa & Main rolls out — what’s next for NYSE:V

7 February 2026
Visa shares closed up 0.74% at $331.58 Friday, holding steady after hours. The company launched “Visa & Main,” a $100 million working-capital facility for small businesses through Lendistry. Investors are watching program adoption and Visa’s Feb. 10 dividend record date. The S&P 500 rose 1.97% and American Express gained 1.28%.
Spotify stock rebounds after-hours as Bookshop.org move and new features tee up Q4 earnings

Spotify stock rebounds after-hours as Bookshop.org move and new features tee up Q4 earnings

7 February 2026
Spotify shares rose 2.4% in late after-hours trading Friday, closing at $422.61. The company this week announced U.S. and U.K. users can order physical books via Bookshop.org in-app, and introduced new audiobook and music features. Spotify raised Premium prices by $1 in select markets, sending shares down 4.5% Thursday. Investors await Q4 earnings on Feb. 10 for updates on revenue and new product impact.
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