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FDA Approvals News 21 December 2025 - 25 December 2025

Abbott Laboratories (ABT) News and Stock Outlook on Dec. 25, 2025: FDA Clears Volt PFA, FreeStyle Libre Alert Persists, Exact Sciences Deal Looms

Abbott Laboratories (ABT) News and Stock Outlook on Dec. 25, 2025: FDA Clears Volt PFA, FreeStyle Libre Alert Persists, Exact Sciences Deal Looms

Dec. 25, 2025 — Abbott Laboratories (NYSE: ABT) heads into the year-end stretch with a rare mix of near-term product momentum and headline-level risk management. Over the past several weeks—culminating in key December announcements—Abbott has (1) secured U.S. FDA approval for a next-generation atrial fibrillation ablation platform, (2) expanded its push into consumer biowearables, (3) navigated an FDA early alert tied to certain FreeStyle Libre sensors, and (4) doubled down on its diagnostics ambitions with a planned ~$23 billion enterprise-value acquisition of Exact Sciences. With U.S. markets closed for Christmas Day, investors are largely assessing Abbott based on its most
Merck & Co. (MRK) Enters 2026 in the Spotlight: BMO Upgrade to $130, FDA Fast-Track Vouchers and TrumpRx Pricing Deal Reframe the Post-Keytruda Story

Merck & Co. (MRK) Enters 2026 in the Spotlight: BMO Upgrade to $130, FDA Fast-Track Vouchers and TrumpRx Pricing Deal Reframe the Post-Keytruda Story

December 25, 2025 — Even with U.S. markets closed for Christmas Day, Merck & Co., Inc. (NYSE: MRK) is ending 2025 as one of the most-watched large-cap pharma names on Wall Street. The stock closed at $106.45 on Wednesday, Dec. 24, and commentary published today points to a six-day winning streak that has pushed investors back into “what’s next” mode: how Merck replaces Keytruda’s eventual loss of exclusivity while navigating a shifting U.S. drug-pricing backdrop. Nasdaq Below is a comprehensive, as-of-today roundup of the most consequential news, forecasts, and analyst analysis shaping Merck’s outlook heading into 2026—covering oncology, cardiovascular ambitions,
Healthcare Stocks Outlook (Dec. 25, 2025): Wegovy Pill Breakthrough, FDA Approvals, and a New Wave of M&A Heading Into 2026

Healthcare Stocks Outlook (Dec. 25, 2025): Wegovy Pill Breakthrough, FDA Approvals, and a New Wave of M&A Heading Into 2026

December 25, 2025 — U.S. markets are closed for Christmas, but healthcare stocks are ending the year with a burst of sector-defining catalysts: a landmark oral GLP‑1 approval for weight loss, multiple FDA green lights that moved biotech names sharply, and a renewed M&A drumbeat as big pharma and rare-disease specialists shop for growth. Below is a detailed, news-driven roundup of the most important healthcare stock headlines, forecasts, and analyst themes investors are digesting as of Dec. 25, 2025—and what they could mean for pharma stocks, biotech stocks, medtech stocks, and health insurance stocks in early 2026. Why healthcare stocks
Novo Nordisk Stock (NVO): Wegovy Pill FDA Approval, CagriSema Filing, and the 2026 Outlook Investors Are Watching (Dec. 25, 2025)

Novo Nordisk Stock (NVO): Wegovy Pill FDA Approval, CagriSema Filing, and the 2026 Outlook Investors Are Watching (Dec. 25, 2025)

December 25, 2025 — Christmas Day is a market holiday in the U.S., but Novo Nordisk A/S is still doing what it’s done for most of the past two years: pulling attention (and capital) toward anything labeled GLP‑1. NASDAQ Trader The headline catalyst is straightforward and extremely investable: the U.S. FDA has approved Novo Nordisk’s Wegovy pill, making it the first oral GLP‑1 treatment approved for chronic weight management in adults with obesity (or overweight with comorbidities). Reuters But the stock story is bigger than a single approval. Heading into 2026, Novo’s equity narrative is being rewritten around three questions:
Bristol-Myers Squibb (BMY) Stock News, Forecasts and Outlook as of Dec. 25, 2025: Breyanzi FDA Win, Eliquis Medicaid Deal, and 2026 Catalysts

Bristol-Myers Squibb (BMY) Stock News, Forecasts and Outlook as of Dec. 25, 2025: Breyanzi FDA Win, Eliquis Medicaid Deal, and 2026 Catalysts

Bristol-Myers Squibb Company (NYSE: BMY) heads into Dec. 25, 2025 with its stock anchored in the mid-$50s — and with investors juggling two competing storylines: With U.S. markets effectively pausing for the holiday, the most recent available NYSE quote showed BMY around $54.71 (last trade timestamp recorded Dec. 24), after trading between roughly $54.20 and $54.75 intraday. Bristol Myers Squibb Investors Bristol-Myers Squibb stock price today: where BMY stands into Dec. 25, 2025 BMS’s own investor quote page showed BMY at $54.71 on Dec. 24 (delayed quote), with a prior close listed as $54.28 and a 52-week range of $42.52
Omeros (OMER) Stock Surges After FDA Approval of Yartemlea: Latest News, Analyst Forecasts, and 2026 Outlook

Omeros (OMER) Stock Surges After FDA Approval of Yartemlea: Latest News, Analyst Forecasts, and 2026 Outlook

December 25, 2025 — Omeros Corporation (NASDAQ: OMER) is having the kind of week biotech investors daydream about: a long-awaited U.S. regulatory win, a sharp stock re-rating, and a sudden pivot from “development-stage hope” to “commercial-stage execution.” The spark was the U.S. FDA approval of YARTEMLEA® (narsoplimab-wuug) as the first and only therapy indicated for hematopoietic stem cell transplant–associated thrombotic microangiopathy (TA‑TMA)—a dangerous complication that can follow stem cell transplantation. Omeros says it is finalizing preparations for a U.S. launch in January 2026, with reimbursement infrastructure already in motion. Omeros Corporation With the FDA decision now public, OMER stock pushed
Omeros (OMER) Stock Surges After Hours on Dec. 24, 2025 After FDA Approves Yartemlea — What to Know Before the Next Market Open

Omeros (OMER) Stock Surges After Hours on Dec. 24, 2025 After FDA Approves Yartemlea — What to Know Before the Next Market Open

Omeros Corporation (NASDAQ: OMER) is ending Christmas Eve 2025 as one of the market’s most volatile and news-driven movers after the U.S. Food and Drug Administration approved the company’s first commercial product — a moment investors have waited years to see. As of 2:35 p.m. ET in after-hours trading on Wednesday, Dec. 24, 2025, OMER stock traded around $15.36, up about $6.59 (+75%) from the prior close, after swinging through a wide intraday range on heavy volume. This move matters not only because it’s dramatic — it’s because it’s tied to a hard catalyst: FDA approval of YARTEMLEA (narsoplimab‑wuug) for
Novo Nordisk (NVO) Stock Jumps as FDA Approves Wegovy Weight-Loss Pill: Latest News, Forecasts, and What Investors Watch Next

Novo Nordisk (NVO) Stock Jumps as FDA Approves Wegovy Weight-Loss Pill: Latest News, Forecasts, and What Investors Watch Next

December 23, 2025 — Novo Nordisk A/S (NYSE: NVO) is back in the spotlight after U.S. regulators approved a pill version of Wegovy, a milestone that could reshape the fast-growing obesity drug market—and potentially reset the narrative around a stock that’s had a bruising 2025. In U.S. trading on Dec. 23, Novo Nordisk shares traded around $52, up roughly 9% on the day, as investors digested what the approval means for market share, pricing power, and the competitive race with Eli Lilly. Reuters What happened to Novo Nordisk stock on Dec. 23, 2025? Novo Nordisk’s rally was driven by a
Novo Nordisk (NVO) Stock Jumps After FDA Approves Wegovy Pill: Today’s News, Analyst Forecasts, and 2026 Catalysts (23 December 2025)

Novo Nordisk (NVO) Stock Jumps After FDA Approves Wegovy Pill: Today’s News, Analyst Forecasts, and 2026 Catalysts (23 December 2025)

Novo Nordisk A/S (NYSE: NVO) is back in the market’s spotlight on 23 December 2025 after a major regulatory milestone: the U.S. Food and Drug Administration approved a pill version of Wegovy, making it the first oral GLP‑1 receptor agonist cleared for chronic weight management in the U.S. The news sent Novo Nordisk shares sharply higher in early trading and reverberated across European markets, where the company’s move helped lift healthcare stocks. Novo Nordisk+2Reuters+2 The approval also lands at a delicate moment for Novo: competition from Eli Lilly has intensified, pricing pressure is building, and investors have been scrutinizing Novo’s
Amgen Stock After Hours (AMGN) on Dec. 22, 2025: FDA Clears New Prolia/Xgeva Biosimilars, Fitch Upgrades Credit — What to Know Before the Dec. 23 Open

Amgen Stock After Hours (AMGN) on Dec. 22, 2025: FDA Clears New Prolia/Xgeva Biosimilars, Fitch Upgrades Credit — What to Know Before the Dec. 23 Open

Amgen Inc. (NASDAQ: AMGN) ended Monday, December 22, 2025, modestly higher, but the more important story for Tuesday’s open is what hit after the closing bell: fresh FDA approvals for new denosumab biosimilars that reference Amgen’s blockbuster bone-drug franchises Prolia and XGEVA—plus a credit-rating upgrade from Fitch that underscores improving balance-sheet flexibility. Below is a complete, investor-focused rundown of what moved (and what could move) Amgen stock before the U.S. market opens Tuesday, December 23, 2025. AMGN stock recap: where Amgen closed and what after-hours traders saw Amgen shares finished the regular session at $331.39, up about 1.2% on the
Cytokinetics (CYTK) Stock Hits 52-Week High as FDA Approval of Myqorzo Triggers Analyst Price-Target Hikes

Cytokinetics (CYTK) Stock Hits 52-Week High as FDA Approval of Myqorzo Triggers Analyst Price-Target Hikes

Cytokinetics, Incorporated (NASDAQ: CYTK) surged on Monday, December 22, 2025, extending a sharp rally that followed the company’s first-ever U.S. drug approval. Shares traded around $69.68 in the session, up roughly 11% from the prior close, after reaching an intraday high near $70.86—a move that pushed the biotech to fresh 52-week highs and re-focused Wall Street on the commercial potential of its newly approved heart drug, Myqorzo (aficamten). Investing.com The immediate catalyst is straightforward: the U.S. Food and Drug Administration approved Myqorzo on December 19, 2025 for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). But the market reaction on December
Johnson & Johnson (JNJ) Stock Week Ahead: Drug-Pricing Politics, Talc Verdicts, and Fresh FDA Wins Set the Tone (Dec 22–26, 2025)

Johnson & Johnson (JNJ) Stock Week Ahead: Drug-Pricing Politics, Talc Verdicts, and Fresh FDA Wins Set the Tone (Dec 22–26, 2025)

As the market heads into a Christmas-shortened trading week, Johnson & Johnson (NYSE: JNJ) is entering the final stretch of 2025 with an unusually headline-heavy mix of catalysts: U.S. drug-pricing negotiations tied to the White House, new talc-related jury verdicts, and a string of FDA and clinical updates that reinforce the company’s longer-term growth narrative. As of the latest close (Friday, December 19, 2025), JNJ ended around $206/share, keeping the stock in a tight, late-year range while investors weigh whether policy risk and litigation uncertainty outweigh the steadier benefits of new product momentum and “defensive” healthcare positioning. MarketBeat Below is
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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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