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FDA Approvals News 11 December 2025 - 17 December 2025

GSK plc (GSK) news: FDA approves twice‑yearly asthma biologic Exdensur on Dec. 17, 2025

GSK plc (GSK) news: FDA approves twice‑yearly asthma biologic Exdensur on Dec. 17, 2025

GSK plc (GSK) announced today that the FDA approved Exdensur (depemokimab‑ulaa) for severe eosinophilic asthma in patients 12+. Here’s what it means for GSK’s respiratory pipeline, competition, and shareholders on 17.12.2025. GSK plc (LSE/NYSE: GSK) is in the spotlight on Wednesday, 17 December 2025, after the company confirmed US FDA approval for Exdensur (depemokimab‑ulaa)—a new twice‑yearly biologic for severe asthma—while…
17 December 2025
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HeartBeam (BEAT) Stock News Today: FDA Clearance Ignites Rally, Analysts Lift Targets, and What Investors Are Watching Next (Dec. 17, 2025)

HeartBeam (BEAT) Stock News Today: FDA Clearance Ignites Rally, Analysts Lift Targets, and What Investors Are Watching Next (Dec. 17, 2025)

December 17, 2025 — HeartBeam, Inc. (NASDAQ: BEAT) has moved from “interesting microcap medtech story” to “market’s attention magnet” in a hurry. The spark: FDA 510(k) clearance for HeartBeam’s 12-lead ECG synthesis software for at-home arrhythmia assessment, granted after the company successfully appealed a prior “Not Substantially Equivalent” (NSE) outcome. HeartBeam, Inc. In the days since, BEAT stock has seen…
17 December 2025
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GSK Stock News Today (Dec. 17, 2025): FDA Approves Twice‑Yearly Asthma Drug Exdensur as Analysts Reassess GSK plc’s 2026 Outlook

GSK Stock News Today (Dec. 17, 2025): FDA Approves Twice‑Yearly Asthma Drug Exdensur as Analysts Reassess GSK plc’s 2026 Outlook

Updated: 17 December 2025 GSK plc stock (LSE: GSK; NYSE: GSK) is in focus on Dec. 17 after a major U.S. regulatory win: the FDA approved Exdensur (depemokimab‑ulaa) for severe asthma—giving GSK a new, ultra‑long‑acting biologic that’s dosed just twice a year. The approval lands as the company approaches a leadership handover on Jan. 1, 2026, and as investors weigh…
17 December 2025
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Eli Lilly Stock (LLY) News Today: Retatrutide Breakthrough, Orforglipron FDA Timeline, and Analyst Forecasts on December 15, 2025

Eli Lilly Stock (LLY) News Today: Retatrutide Breakthrough, Orforglipron FDA Timeline, and Analyst Forecasts on December 15, 2025

December 15, 2025 — Eli Lilly and Company (NYSE: LLY) stock is starting the new week in focus as investors weigh a rapid-fire set of catalysts: a headline-grabbing Phase 3 result for next‑generation obesity drug retatrutide, fresh scrutiny around the FDA review timeline for oral GLP‑1 candidate orforglipron, ongoing capacity expansion in the U.S., and a notable analyst price-target tweak…
15 December 2025
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Milestone Pharmaceuticals (MIST) Stock: FDA Approval of CARDAMYST, Launch Timeline, and Analyst Forecasts (Dec. 15, 2025)

Milestone Pharmaceuticals (MIST) Stock: FDA Approval of CARDAMYST, Launch Timeline, and Analyst Forecasts (Dec. 15, 2025)

Milestone Pharmaceuticals Inc. (NASDAQ: MIST) entered a new phase in its corporate life this month: from clinical-stage story stock to a company with an FDA-approved, commercially launchable cardiovascular product. The catalyst is CARDAMYST™ (etripamil) nasal spray, now approved in the U.S. for adults experiencing acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT)—a rapid heart rhythm disturbance that can be frightening,…
15 December 2025
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Eli Lilly Stock (LLY) News, Forecasts and Analyst Outlook — Retatrutide Breakthrough, Orforglipron FDA Timeline, and a $6B Manufacturing Bet (Dec. 14, 2025)

Eli Lilly Stock (LLY) News, Forecasts and Analyst Outlook — Retatrutide Breakthrough, Orforglipron FDA Timeline, and a $6B Manufacturing Bet (Dec. 14, 2025)

Updated: December 14, 2025 Eli Lilly and Company (NYSE: LLY) heads into the new week with investors focused on one big theme: how far the company can extend its lead in obesity and cardiometabolic medicine while scaling supply and navigating pricing pressure. The stock’s most recent close (U.S. markets were shut Sunday) was $1,027.51. StockAnalysis Over the past two weeks,…
14 December 2025
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Milestone Pharmaceuticals (MIST) Stock Update: FDA Approves CARDAMYST (Etripamil) — This Week’s Volatility, Analyst Forecasts, and What to Watch Next (Updated Dec. 12, 2025)

Milestone Pharmaceuticals (MIST) Stock Update: FDA Approves CARDAMYST (Etripamil) — This Week’s Volatility, Analyst Forecasts, and What to Watch Next (Updated Dec. 12, 2025)

Updated: Friday, December 12, 2025 (U.S. market close) Milestone Pharmaceuticals Inc. (NASDAQ: MIST) closed out the week in the spotlight after the company announced U.S. FDA approval of CARDAMYST™ (etripamil)—positioning Milestone to transition from a development-stage biotech to a commercial-stage cardiovascular company. GlobeNewswire The stock action was anything but calm. MIST closed at $2.41 on Dec. 12, down 18.31%, after…
14 December 2025
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Eli Lilly stock LLY after hours on Dec. 12, 2025: Mounjaro pediatric EU nod, FDA orforglipron fast-track scrutiny, and what to watch next

Eli Lilly stock LLY after hours on Dec. 12, 2025: Mounjaro pediatric EU nod, FDA orforglipron fast-track scrutiny, and what to watch next

Eli Lilly and Company shares ended Friday, Dec. 12, 2025 higher — and held roughly steady in after-hours trading — as investors weighed a fresh European regulatory boost for Mounjaro, new reporting on the FDA’s internal debate over speeding up a decision on Lilly’s oral obesity pill, and late-stage oncology data presented at a major medical meeting. After the bell:…
12 December 2025
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GSK Stock News Today (Dec. 12, 2025): Arexvy EU Expansion, Blujepa FDA Approval, Analyst Forecasts and What’s Next

GSK Stock News Today (Dec. 12, 2025): Arexvy EU Expansion, Blujepa FDA Approval, Analyst Forecasts and What’s Next

Published: 12 December 2025 GSK plc stock is back in focus on Friday as investors digest a fast-moving cluster of regulatory headlines across vaccines, infectious diseases and oncology—alongside ongoing buybacks and fresh consensus forecasts that map out how GSK’s revenue mix may evolve into 2031. On the New York Stock Exchange, GSK’s U.S.-listed ADR was trading around $48.88 in the…
12 December 2025
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Pfizer (PFE) Stock Outlook After the November 21 FDA Win: Obesity Deals, Cost Cuts and a 6.7% Dividend Yield

Pfizer (PFE) Stock Outlook After the November 21 FDA Win: Obesity Deals, Cost Cuts and a 6.7% Dividend Yield

As of December 11, 2025, Pfizer Inc. (NYSE: PFE) is trying to rewrite its post‑COVID story. The stock trades around $25.66 per share, after a choppy year of guidance upgrades, obesity-drug M&A, aggressive cost cuts and fresh regulatory wins in oncology and rare disease. Since November 21, 2025, a cluster of headlines — from an FDA approval in bladder cancer…
11 December 2025
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Arrowhead Pharmaceuticals (ARWR) Stock Near 52‑Week High After FDA Approval and New Alzheimer’s Trial: Latest News & Forecasts as of December 11, 2025

Arrowhead Pharmaceuticals (ARWR) Stock Near 52‑Week High After FDA Approval and New Alzheimer’s Trial: Latest News & Forecasts as of December 11, 2025

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has quietly turned into one of 2025’s wildest biotech comeback stories. After years as a perpetually “promising” RNA interference (RNAi) platform, the company now has: The stock price has responded in full drama mode. As of the afternoon of December 11, 2025, Arrowhead shares are trading around $70, having touched intraday highs above $72 and notching…
11 December 2025
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AbbVie Stock (ABBV): HSBC Upgrade, Dividend Hike and New FDA Win Reshape the 2025 Outlook

AbbVie Stock (ABBV): HSBC Upgrade, Dividend Hike and New FDA Win Reshape the 2025 Outlook

AbbVie Inc. (NYSE: ABBV) has quietly turned into one of 2025’s standout large‑cap pharma stories. Shares are up roughly a mid‑20% percentage year‑to‑date, outpacing the broader market, powered by booming sales of Skyrizi and Rinvoq, a fresh dividend hike, and a string of oncology milestones — capped by an HSBC upgrade that just put AbbVie on the firm’s “preferred buys”…
11 December 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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