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FDA Approvals News 17 December 2025 - 21 December 2025

Biotechnology Stocks Week Ahead (Dec. 22–26, 2025): BioMarin–Amicus Deal, Cytokinetics FDA Win, IPO Filings, and Drug-Price Policy Risks

Biotechnology Stocks Week Ahead (Dec. 22–26, 2025): BioMarin–Amicus Deal, Cytokinetics FDA Win, IPO Filings, and Drug-Price Policy Risks

Biotechnology stocks head into the Christmas-shortened trading week with fresh momentum—and plenty for investors to digest—after a dense run of catalysts between December 19 and December 21, 2025. In the span of 48 hours, the sector saw a major rare-disease acquisition, a closely watched FDA approval in cardiology, IPO paperwork from both biotech and medtech, and a sweeping wave of U.S. drug-pricing headlines that could reshape sentiment into 2026. Investopedia+4Reuters+4Reuters+4 The setup matters because next week’s market structure will be unusual: U.S. stock markets are scheduled to close early on Wednesday, December 24 (1:00 p.m. ET) and remain closed on
21 December 2025
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Amgen Stock (AMGN) News Today: TrumpRx Drug-Price Deal, FDA Approvals, Dividend Update, and 2026 Analyst Forecasts

Amgen Stock (AMGN) News Today: TrumpRx Drug-Price Deal, FDA Approvals, Dividend Update, and 2026 Analyst Forecasts

December 20, 2025 — Amgen Inc. (NASDAQ: AMGN) is closing out the year with a rare combination of near-term policy headlines and company-specific catalysts that matter to investors: a new U.S. drug-pricing deal tied to the TrumpRx rollout, fresh FDA approvals that expand the growth runway, reaffirmed shareholder returns via dividends, and a split—but active—Wall Street outlook heading into 2026. AMGN last traded around $327.38, reflecting the most recent available market print (U.S. markets are closed today). Below is a detailed, publication-ready breakdown of today’s key Amgen stock news, along with forecasts and analyst analysis relevant as of 20.12.2025. What’s
20 December 2025
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GSK plc Stock News and Forecast (Dec. 20, 2025): TrumpRx Pricing Deal, Exdensur FDA Approval, Buybacks, and Analyst Targets

GSK plc Stock News and Forecast (Dec. 20, 2025): TrumpRx Pricing Deal, Exdensur FDA Approval, Buybacks, and Analyst Targets

GSK plc (LSE: GSK; NYSE: GSK) heads into the weekend with a rare “everything-bagel” mix of catalysts: a new U.S. drug-pricing agreement tied to tariff relief, a fresh FDA approval that could reshape severe-asthma dosing schedules, expanding vaccine indications in Europe, and a steady drumbeat of buybacks. For investors tracking GSK stock, the headline isn’t just one event—it’s the way policy, pipeline, and capital returns are colliding in the same two-week window. Because December 20, 2025 is a Saturday, markets are closed. In U.S. trading, GSK’s ADR last closed on Friday, Dec. 19 at $48.61. StockAnalysis Below is a detailed
20 December 2025
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Merck (MRK) Stock News and Forecasts for Dec. 19, 2025: Drug-Pricing Deals, FDA Fast-Track Catalysts, and Wall Street Targets

Merck (MRK) Stock News and Forecasts for Dec. 19, 2025: Drug-Pricing Deals, FDA Fast-Track Catalysts, and Wall Street Targets

Merck & Co., Inc. (NYSE: MRK) stock traded higher on Friday, December 19, 2025, as investors balanced two big forces that tend to move large-cap pharma: U.S. drug-pricing policy headlines and pipeline-driven growth prospects. Shares were around $101.71, up about 1% from the prior close, as the market digested White House signals on new pricing agreements and fresh read-throughs from late-2025 clinical and regulatory developments. Below is a comprehensive, news-style breakdown of what’s driving Merck stock right now, what analysts are forecasting, and the key catalysts investors are tracking into 2026—based on reporting and company statements available on 19.12.2025. Where
19 December 2025
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Disc Medicine (NASDAQ: IRON) Stock Tumbles on Insider-Selling Headlines as Bitopertin FDA Decision Nears — News, Analyst Forecasts, and What to Watch (Dec. 19, 2025)

Disc Medicine (NASDAQ: IRON) Stock Tumbles on Insider-Selling Headlines as Bitopertin FDA Decision Nears — News, Analyst Forecasts, and What to Watch (Dec. 19, 2025)

Disc Medicine, Inc. stock (NASDAQ: IRON) sank sharply on Friday, Dec. 19, 2025, with IRON down about 10% in late-morning trading and swinging through a wide intraday range that, at one point, dipped into the low $70s before rebounding toward the low $80s. MarketScreener The timing matters: the selloff arrives just weeks before investors expect clarity on Disc’s most important near-term catalyst—an FDA decision on bitopertin for erythropoietic protoporphyria (EPP)—and amid a burst of insider-trading disclosures and Form 144 filings that can spook momentum-driven biotech traders even when sales are planned. MarketBeat+1 Below is a full, up-to-date roundup of what’s
19 December 2025
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Johnson & Johnson Stock (JNJ) After Hours Today (Dec. 18, 2025): FDA Approvals, Analyst Targets, and Talc Litigation in Focus Ahead of Friday’s Open

Johnson & Johnson Stock (JNJ) After Hours Today (Dec. 18, 2025): FDA Approvals, Analyst Targets, and Talc Litigation in Focus Ahead of Friday’s Open

Johnson & Johnson (NYSE: JNJ) finished Thursday’s regular session lower even as the broader market moved higher, then ticked modestly upward in after-hours trading—leaving investors with a familiar year-end setup: solid pipeline/MedTech progress on one side, and talc litigation headlines on the other. JNJ stock price after the bell: the key numbers investors are watching tonight JNJ shares closed the regular session at $208.31, down $2.02 (-0.96%), and were slightly higher after hours at about $208.65 (+0.16%) in early evening trading. Investing.com A few additional “snapshot” metrics help frame where JNJ sits heading into Friday’s open: On a day when
19 December 2025
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Merck & Company, Inc. (MRK) Stock News and Forecasts: FDA Fast-Track Signals, BMO Upgrade, and a New Keytruda–Padcev Win (Dec. 18, 2025)

Merck & Company, Inc. (MRK) Stock News and Forecasts: FDA Fast-Track Signals, BMO Upgrade, and a New Keytruda–Padcev Win (Dec. 18, 2025)

December 18, 2025 — Merck & Company, Inc. (NYSE: MRK) is back in the spotlight for investors today as three threads converge: a fresh Wall Street upgrade tied to Merck’s post‑Keytruda strategy, a potentially meaningful FDA fast‑track development for two pipeline assets, and new Phase 3 momentum for the company’s blockbuster oncology franchise in earlier‑stage bladder cancer. Merck shares traded around $101 intraday on Thursday, reflecting a modest gain versus the prior close, as markets absorbed a busy stream of pharma catalysts and analyst commentary. StockAnalysis Below is a comprehensive, publication‑ready roundup of the key news, forecasts, and analyses dated
18 December 2025
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Johnson & Johnson Stock (JNJ) News Today: FDA Approvals, Analyst Price Targets, and the 2026 Outlook (Dec. 18, 2025)

Johnson & Johnson Stock (JNJ) News Today: FDA Approvals, Analyst Price Targets, and the 2026 Outlook (Dec. 18, 2025)

Johnson & Johnson (NYSE: JNJ) stock traded around $208 on Thursday, December 18, 2025, with shares modestly lower on the session as investors weighed a busy late-year news cycle that includes fresh FDA wins in MedTech and oncology, new Wall Street target updates, and the continued legal overhang from talc litigation. For long-term holders, the story remains familiar: J&J is a diversified healthcare bellwether spanning Innovative Medicine and MedTech—a blend that can cushion volatility, but also means the stock tends to react to a wide mix of regulatory, clinical, litigation, and analyst-driven headlines. Reuters Below is what matters most for
18 December 2025
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GSK Stock News Today (Dec. 18, 2025): Buyback Update, New FDA Approvals, and Analyst Forecasts for GSK plc

GSK Stock News Today (Dec. 18, 2025): Buyback Update, New FDA Approvals, and Analyst Forecasts for GSK plc

GSK plc (LSE: GSK; NYSE: GSK) is ending 2025 with a busy headline tape—exactly the kind of environment where investors tend to re-check both the “story” and the spreadsheet. On Thursday, December 18, 2025, GSK published a fresh share buyback update, while markets continue to digest a string of regulatory milestones across respiratory, vaccines, and infectious diseases that could shape the company’s growth profile into 2026. Below is what’s new as of 18.12.2025, what analysts are forecasting, and what matters most for GSK stock next. GSK stock snapshot on Dec. 18, 2025 In US trading, GSK’s ADR (NYSE: GSK) was
18 December 2025
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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 also releasing its latest share buyback update through a regulatory filing. Investegate+1 Below is a full, reader-friendly rundown of all current GSK news items dated 17.12.2025, plus what they signal for patients, clinicians, and investors. Today’s GSK headlines (17.12.2025) 1)
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 sharp swings and outsized volume, a familiar pattern when a small-cap name lands a major regulatory milestone. At the Dec. 16 close, BEAT traded around $3.44, up roughly 31% on the day, and early Dec. 17 pre-market quotes indicated continued
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 whether GSK’s late‑2025 pipeline momentum can translate into durable earnings growth in 2026 and beyond. Reuters+2GSK+2 Below is a full, news-driven breakdown of what’s moving GSK stock today, the most important recent catalysts, and how current analyst forecasts and technical
17 December 2025
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Stock Market Today

Wall Street Feels the Heat (and Thrill): Fed Cuts, Tariffs & Mega-Mergers Set NYSE Buzz

Stock Market Today 07.02.2026

7 February 2026
LIVEMarkets rolling coverageStarted: February 7, 2026, 12:00 AM ESTUpdated: February 7, 2026, 12:27 AM EST Dollar Dips as Stocks Rally and US Data Influences Fed Rate Expectations February 7, 2026, 12:18 AM EST. The **dollar index** fell 0.17%, pressured by a rebound in equity markets reducing demand for the safe-haven currency. Weaker-than-expected U.S. labor market data raised the odds of a Fed rate cut to 18% for March, though consumer sentiment improved to a six-month high, limiting losses. Hawkish comments from Atlanta Fed's Raphael Bostic emphasized maintaining restrictive monetary policy. The dollar faces medium-term weakness amid expectations for rate cuts
Seagate (STX) stock jumps nearly 6% as Citi hikes target — what to watch next week

Seagate (STX) stock jumps nearly 6% as Citi hikes target — what to watch next week

7 February 2026
Seagate shares rose 5.9% to $429.32 Friday after Citigroup raised its price target to $480 and reiterated a buy rating. The gain ended a two-day slide but left the stock 6.6% below its Feb. 3 high. CEO Dave Mosley sold 20,000 shares on Feb. 2 under a pre-arranged plan, SEC filings show. U.S. jobs and inflation data next week are seen as key tests for tech stocks.
Cummins (CMI) stock price rebounds after earnings whipsaw as investors eye data-center power demand

Cummins (CMI) stock price rebounds after earnings whipsaw as investors eye data-center power demand

7 February 2026
Cummins shares jumped 6.8% to $577.73 Friday, recovering from a nearly 9% post-earnings drop the day before. The company reported Q4 revenue up 1% to $8.54 billion, took a $218 million charge tied to its hydrogen business, and guided for 2026 EBITDA of 17–18% of sales. Demand for data center generators offset weakness in North American truck markets. Analyst reaction was mixed; Truist raised its price target.
Corning stock hits first record close since 2000 as jobs, CPI data loom

Corning stock hits first record close since 2000 as jobs, CPI data loom

7 February 2026
Corning shares surged 8.3% to $122.16 Friday, their highest close since the dot-com era, after Meta agreed to buy up to $6 billion in fiber-optic cables. The stock is up 40% since late 2025, fueled by strong first-quarter guidance and AI data-center demand. Insiders sold shares following the rally, SEC filings show. Investors await next week’s U.S. jobs and inflation data for rate signals.
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