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FDA Approvals News 21 October 2025 - 10 December 2025

GSK Stock on 10 December 2025: FDA Orphan-Drug Win, New Cancer Deal and What It Means for Investors

GSK Stock on 10 December 2025: FDA Orphan-Drug Win, New Cancer Deal and What It Means for Investors

GSK plc (LSE: GSK; NYSE: GSK) is ending 2025 in full “pipeline flex” mode. On 10 December 2025 the company announced fresh US regulatory momentum for an experimental lung cancer drug and a new oncology collaboration, while the share price sits near multi‑year highs after a year of strong earnings and upgraded guidance. Stock Titan Below is a deep dive…
10 December 2025
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Arrowhead Pharmaceuticals (ARWR) Soars to Fresh Highs on Alzheimer’s Trial and FDA Breakthrough Wins

Arrowhead Pharmaceuticals (ARWR) Soars to Fresh Highs on Alzheimer’s Trial and FDA Breakthrough Wins

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) is finishing 2025 with the kind of momentum small-molecule biotechs daydream about. On 8 December 2025, the RNA interference (RNAi) specialist climbed to a new 52‑week high near $69 per share after the company announced it had dosed the first subjects in its Alzheimer’s disease trial ARO‑MAPT and highlighted a string of recent FDA victories…
8 December 2025
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Medtronic PLC (MDT) Stock Outlook December 7, 2025: Price, Dividend, Hugo Robot FDA Win and 2026 Forecast

Medtronic PLC (MDT) Stock Outlook December 7, 2025: Price, Dividend, Hugo Robot FDA Win and 2026 Forecast

Updated: December 7, 2025 Key Takeaways 1. Medtronic (MDT) Stock Snapshot on December 7, 2025 As of the latest completed trading session (Dec. 5, 2025), Medtronic’s NYSE‑listed shares closed at $101.36, with modest after‑hours trading around $101.31. StockAnalysis Key stats at a glance: Trading over the last week has been choppy as markets digest macro headlines and rotations within healthcare.…
7 December 2025
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Praxis Precision Medicines (PRAX) Stock Soars After Epilepsy Breakthrough and FDA Pre‑NDA Win

Praxis Precision Medicines (PRAX) Stock Soars After Epilepsy Breakthrough and FDA Pre‑NDA Win

Praxis Precision Medicines, Inc. (NASDAQ: PRAX) ripped higher again on 5 December 2025, extending one of the most dramatic biotech rallies of the year after positive epilepsy data and a favorable pre‑NDA meeting with the FDA. By the closing bell on Friday, PRAX finished at $247.99, up 30.5% on the day, with a new 52‑week range of $26.70–$277.44 and a…
6 December 2025
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Praxis Precision Medicines (PRAX) Soars on FDA Momentum and Epilepsy Breakthroughs as Stock Hits New High on December 5, 2025

Praxis Precision Medicines (PRAX) Soars on FDA Momentum and Epilepsy Breakthroughs as Stock Hits New High on December 5, 2025

Praxis Precision Medicines, Inc. (NASDAQ: PRAX) extended its remarkable 2025 rally on Friday, December 5, with shares surging almost 40% intraday after the company reported a double dose of good news: a pivotal epilepsy trial stopped early for efficacy and a positive pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for its lead essential tremor drug. StockAnalysis By…
5 December 2025
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Eli Lilly (LLY) Stock Today, 4 December 2025: Zepbound Price Cuts, Jaypirca FDA Win and New $1,200–$1,500 Targets

Eli Lilly (LLY) Stock Today, 4 December 2025: Zepbound Price Cuts, Jaypirca FDA Win and New $1,200–$1,500 Targets

Date: 4 December 2025 Eli Lilly stock at a glance Eli Lilly and Company (NYSE: LLY) is trading around $1,030–$1,040 per share on 4 December 2025, down roughly 1% on the session after slipping from about $1,046 in the previous close. Intraday, the stock has been oscillating roughly between $1,022 and $1,051. Intellectia Over the past year, Lilly shares have…
4 December 2025
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Merck (MRK) Stock on December 2, 2025: Dividend Hike, FDA Wins and Fresh Wall Street Targets

Merck (MRK) Stock on December 2, 2025: Dividend Hike, FDA Wins and Fresh Wall Street Targets

Merck & Co., Inc. (NYSE: MRK) is wrapping up 2025 with a flurry of news that matters to shareholders: a bigger dividend, new analyst price targets, fresh regulatory approvals for its cancer blockbuster Keytruda, and high‑profile acquisitions aimed at life after its 2028 patent cliff. As of early afternoon on December 2, 2025, Merck shares trade around $101 (roughly $100.8–$101.0,…
2 December 2025
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Merck (MRK) Stock Could Skyrocket: Key Drug Approvals & Analyst Targets Unveiled

Merck (MRK) Rallies on Nov. 11, 2025: FDA Approves New Keytruda Companion Diagnostic; Fresh SITC Combo Data, and Dow Momentum

Published: November 11, 2025 At a glance (today) Market move: MRK helps lead the Dow’s advance By early afternoon Tuesday, Merck & Co. (NYSE: MRK) shares were up about 3.9%, helping lead the Dow Jones Industrial Average higher; Nike and Merck together contributed an estimated ~36 points to the index’s ~386‑point climb at that time. MarketWatch In a separate Data…
11 November 2025
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NeurAxis (NRXS) Stock Skyrockets on First-Ever FDA Approval for GI Pain Device

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 up) for functional abdominal pain associated with FD and nausea, a segment previously lacking any approved device treatment Investing. Investing.com and other outlets confirm this milestone — noting…
24 October 2025
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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 customer orders for Arbli (losartan suspension), immediately triggering the Nasdaq surge Finviz. CEO/co-CEO Narasimhan Mani said the event “represents a major achievement for Scienture” in moving from development…
24 October 2025
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Scienture Holdings (SCNX) Stock Skyrockets on FDA Drug Launch – Will the Rally Last?

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 company announced Arbli™ was available through major wholesalers – making it the first FDA-approved liquid losartan on the market ts2.tech. That morning, SCNX shares surged over 30% from…
23 October 2025
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Replimune Stock Rockets 100% on FDA Nod – Analysts Eye Upside

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 day Marketbeat. (On Oct 21, REPL was trading around $8.95 Reuters.) This reversed a mid-year collapse – in July 2025 a disappointing FDA Complete Response Letter caused the…
21 October 2025
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Stock Market Today

  • Cotton futures fall on Friday as export pace trails five-year average
    January 17, 2026, 5:18 PM EST. Cotton futures fell Friday, with most contracts down 15 to 30 points. The US dollar index was down about 343 points, while crude oil slid $1.64 a barrel. USDA Export Sales for 2024/25 stood at 4.213 million running bales sold or shipped, about 37% of the USDA projection and roughly 12 percentage points behind the five-year average pace. ICE cotton stocks were unchanged at 15,526 bales. The Cotlook A Index dropped 100 points to 78.45 cents per pound. The USDA Average World Price (AWP) for next week rose to 55.35 cents/lb, up 11 points. Quotes: Dec 24 at 67 (-15); Mar 25 at 68.49 (-23); May 25 at 69.76 (-28). On the date of publication, Alan Brugler had no positions.
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