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FDA Updates News 11 December 2025 - 18 December 2025

Merck (MRK) Stock After Hours: FDA Fast‑Track Vouchers, Keytruda‑Padcev Trial Win, and What to Watch Before the Dec. 18 Market Open

Merck (MRK) Stock After Hours: FDA Fast‑Track Vouchers, Keytruda‑Padcev Trial Win, and What to Watch Before the Dec. 18 Market Open

Merck & Co., Inc. (NYSE: MRK) finished regular trading on Wednesday, Dec. 17, 2025 in positive territory, then held near the $99 level in extended hours as investors weighed two major pipeline headlines—one before the opening bell and another after the close—alongside a renewed policy backdrop around U.S. drug pricing. Investing.com+1 Below is what moved MRK today, what the late-breaking after-hours news could mean, and what to keep on your radar before U.S. markets open Thursday, Dec. 18. Merck stock recap: where MRK stands after the bell (Dec. 17) Merck shares closed at $99.18 on Dec. 17, up 0.93% on
18 December 2025
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Johnson & Johnson Stock After Hours (Dec. 17, 2025): JNJ Closes Higher on FDA News—What to Know Before the Market Opens Thursday

Johnson & Johnson Stock After Hours (Dec. 17, 2025): JNJ Closes Higher on FDA News—What to Know Before the Market Opens Thursday

Johnson & Johnson (NYSE: JNJ) ended Wednesday’s session modestly higher—an eye-catching show of relative strength on a down day for major U.S. indexes—while investors digested a fresh FDA approval tied to the company’s lung cancer franchise and looked ahead to a potentially market-moving inflation print before Thursday’s open. After the closing bell on Dec. 17, 2025, JNJ shares finished at $210.33 and traded slightly higher in after-hours at $210.48. Google JNJ stock after the bell: the numbers investors are watching Johnson & Johnson’s stock action late Wednesday was calm—but the details matter when you’re assessing what could drive the next
18 December 2025
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Telix Pharmaceuticals (TLX) Stock Slides on Dec. 17, 2025: ProstACT Phase 3 Update, FDA Zircaix Overhang, Lawsuit Headlines, and Fresh Analyst Forecasts

Telix Pharmaceuticals (TLX) Stock Slides on Dec. 17, 2025: ProstACT Phase 3 Update, FDA Zircaix Overhang, Lawsuit Headlines, and Fresh Analyst Forecasts

Telix Pharmaceuticals Limited (ASX:TLX, Nasdaq:TLX) entered the spotlight again on December 17, 2025, as TLX stock extended its December sell-off amid a fast-moving mix of clinical-trial updates, regulatory overhang, and investor litigation headlines. Telix Pharmaceuticals+2Investing.com+2 On the ASX, Telix shares closed at A$11.73, down 6.61% on the session, with a wide intraday range from A$11.535 to A$12.730 and volume of roughly 6.36 million shares—a notably volatile day by recent standards. Investing.com+1 In the U.S., Telix’s Nasdaq-listed shares/ADS were also under pressure, with U.S. market coverage noting a gap-down move and a roughly 6%–7% decline in early trading action on Dec.
17 December 2025
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Johnson & Johnson Stock (JNJ) News Today: RBC Raises Target to $240 as FDA Actions and Talc Verdict Shape the 2026 Outlook

Johnson & Johnson Stock (JNJ) News Today: RBC Raises Target to $240 as FDA Actions and Talc Verdict Shape the 2026 Outlook

CAs of Wednesday, December 17, 2025, Johnson & Johnson (NYSE: JNJ) is back in focus for investors looking for a “defensive” large-cap healthcare stock—while also weighing two forces that can move JNJ shares quickly: drug pipeline catalysts and talc litigation headlines. JNJ shares are trading around $210 today, after a volatile stretch that included a sharp pullback on Tuesday, December 16, and renewed analyst attention mid-week. StockAnalysis JNJ stock snapshot: where shares stand on December 17, 2025 JNJ is hovering near the low-$210s, a level that puts the stock close to recent highs for 2025—an important context point because it
17 December 2025
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GSK plc Stock News Today (16.12.2025): Exdensur UK Approval Puts GSK Shares in Focus as FDA Decision Looms

GSK plc Stock News Today (16.12.2025): Exdensur UK Approval Puts GSK Shares in Focus as FDA Decision Looms

December 16, 2025 — GSK plc stock (LSE: GSK; NYSE: GSK) is firmly on investors’ radar today after a cluster of late-year regulatory catalysts across respiratory, vaccines, and infectious diseases — the kind of headline flow that can reshape sentiment around a large-cap biopharma even when quarterly earnings are weeks away. In the latest available market data, GSK’s US-listed ADR (NYSE: GSK) traded around $49.24 (latest trade time in the feed: Dec. 16, 2025 00:15 UTC). Meanwhile, in London, GSK shares most recently closed at 1,833.50p on Dec. 15, up 0.49% on the day, with the Financial Times’ market data
16 December 2025
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Johnson & Johnson Stock After Hours (Dec. 15, 2025): JNJ Rises on FDA Priority Voucher — What to Know Before Tuesday’s Open

Johnson & Johnson Stock After Hours (Dec. 15, 2025): JNJ Rises on FDA Priority Voucher — What to Know Before Tuesday’s Open

Johnson & Johnson (NYSE: JNJ) shares finished Monday, December 15, 2025 higher and held modest gains in extended trading — a notable showing for a defensive blue chip as investors brace for a data-heavy week and shifting rate expectations. JNJ closed at $214.17 (+1.22%) and traded around $214.99 in after-hours (+0.38%) as of 7:15 p.m. ET. During the regular session, the stock moved between $209.01 and $215.19 on roughly 8.4 million shares. StockAnalysis+1 In the broader market, U.S. stocks ended slightly lower on Monday as investors positioned for major economic releases later this week. TradingView What moved Johnson & Johnson
16 December 2025
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Johnson & Johnson Stock (JNJ) Today: FDA Fast‑Track Voucher Lifts Oncology Narrative as Talc Verdict Renews Legal Overhang

Johnson & Johnson Stock (JNJ) Today: FDA Fast‑Track Voucher Lifts Oncology Narrative as Talc Verdict Renews Legal Overhang

Johnson & Johnson stock (NYSE: JNJ) is starting the week at the center of two storylines that often tug the share price in opposite directions: accelerating momentum in oncology and a stubborn, headline‑driven litigation risk. On Monday, December 15, 2025, JNJ shares traded around the $214 level, brushing the upper end of their recent trading range and extending a rally that has put the healthcare bellwether sharply higher on the year. Investing.com+2MarketScreener+2 What’s moving JNJ today isn’t a single earnings surprise. Instead, it’s a high‑impact regulatory catalyst—a newly granted FDA priority voucher tied to a multiple myeloma regimen—arriving the same
15 December 2025
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Aspire Biopharma Holdings (ASBP) Stock on Dec. 15, 2025: Nasdaq Extension, FDA Pre‑IND Momentum, and Dilution Risks Investors Are Watching

Aspire Biopharma Holdings (ASBP) Stock on Dec. 15, 2025: Nasdaq Extension, FDA Pre‑IND Momentum, and Dilution Risks Investors Are Watching

Aspire Biopharma Holdings, Inc. (Nasdaq: ASBP) is stepping into December 15, 2025 with a very “micro-cap biotech” mix of catalysts and pressure points: a Nasdaq deadline calendar, an FDA regulatory milestone for its lead sublingual aspirin program, and capital-structure dynamics that can swing sentiment fast. ASBP shares were trading around $0.095 as of mid-morning UTC on December 15, 2025 (down roughly 8% on the session at that timestamp). That sub‑$0.10 neighborhood matters—not as a psychological trivia point, but because the company is actively working through Nasdaq continued-listing requirements and a recapitalization narrative that’s hard to ignore. Barchart.com+1 Below is a
15 December 2025
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GSK plc Stock News & Forecasts (Dec. 15, 2025): FDA Catalyst for Depemokimab, EU Backs Nucala and Arexvy, Analysts Map the Path Ahead

GSK plc Stock News & Forecasts (Dec. 15, 2025): FDA Catalyst for Depemokimab, EU Backs Nucala and Arexvy, Analysts Map the Path Ahead

GSK plc Stock News & Forecasts (Dec. 15, 2025): FDA Catalyst for Depemokimab, EU Backs Nucala and Arexvy, Analysts Map the Path Ahead GSK plc stock (LSE: GSK, NYSE: GSK) is ending 2025 with a rare “cluster” of market-moving catalysts packed into the same two-week window: fresh U.S. regulatory momentum for a new antibiotic, European regulatory backing for multiple respiratory products, and an imminent FDA decision that could reshape GSK’s long-term outlook in severe asthma and nasal polyps. For investors, this isn’t just headline noise. It’s the kind of sequencing—approval decisions, label expansions, and portfolio reinforcement—that can change how analysts
15 December 2025
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GSK Stock News & Forecast (Week Ahead): CHMP Endorsements, FDA Label Expansion, Buyback Updates — Updated Dec. 14, 2025

GSK Stock News & Forecast (Week Ahead): CHMP Endorsements, FDA Label Expansion, Buyback Updates — Updated Dec. 14, 2025

Updated: Sunday, December 14, 2025 (markets closed; prices reflect the most recent close). GSK plc (LSE: GSK / NYSE: GSK) heads into mid‑December with a rare “cluster catalyst” setup: multiple fresh European regulator panel endorsements, a new U.S. label expansion for an antibiotic, and steady buyback activity. That combination doesn’t guarantee a breakout (stocks are fickle creatures), but it does give investors a clearer map of what could move GSK shares in the days ahead. As of the latest available trading data, GSK’s U.S. ADR last traded around $48.81. In London, the most recent close was 1,824.5p (Dec. 12, 2025).
14 December 2025
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Milestone Pharmaceuticals (MIST) Stock in Focus on Dec. 12, 2025: FDA Decision Countdown, Latest News, Analyst Forecasts, and Key Risks

Milestone Pharmaceuticals (MIST) Stock in Focus on Dec. 12, 2025: FDA Decision Countdown, Latest News, Analyst Forecasts, and Key Risks

Updated: December 12, 2025Company: Milestone Pharmaceuticals Inc. ( NASDAQ: MIST ) Milestone Pharmaceuticals Inc. stock is drawing heightened attention on December 12, 2025 , as investors position ahead of a make-or-break FDA decision for the company’s lead program, CARDAMYST™ (etripamil) nasal spray , aimed at treating paroxysmal supraventricular tachycardia (PSVT) . The regulatory catalyst arrives after a volatile year that included an FDA Complete Response Letter (CRL) earlier in 2025, followed by the FDA’s acceptance of Milestone’s resubmission and a new target action date set for mid-December.GlobeNewswire+ 2GlobeNewswire+ 2 In the market, MIST shares closed at $2.95 on Dec. 11
12 December 2025
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GSK Stock (LON:GSK, NYSE:GSK): Latest News, FDA Catalysts and 2026 Outlook – December 11, 2025

GSK Stock (LON:GSK, NYSE:GSK): Latest News, FDA Catalysts and 2026 Outlook – December 11, 2025

GSK plc stock has quietly morphed from a problem child of Big Pharma into one of 2025’s more interesting “value with growth” stories. The shares are trading near multi‑year highs, the company has upgraded guidance, big litigation overhangs are easing, and a cluster of U.S. FDA decisions is about to test how much of that optimism is justified. As of last night’s close, GSK’s U.S. ADR finished at $48.40, up more than 45% year‑to‑date, while the London‑listed shares recently changed hands around 1,800p, having pushed above their 200‑day moving average of 1,547.73p on heavy volume. MarketBeat+1 Below is a deep
11 December 2025
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Stock Market Today

iFAST share price drops 3% as markets shut; earnings next week in focus

iFAST share price drops 3% as markets shut; earnings next week in focus

7 February 2026
iFAST shares fell 3.2% to S$9.64 in heavy trading Friday, closing near the day’s low as investors awaited FY2025 results due Feb. 12. The stock is about 13% below its 52-week high. iFAST recently agreed to buy a 30% stake in Financial Alliance for S$19.6 million, pending regulatory approval. Assets under administration stood at S$30.62 billion as of Sept. 30.
Sembcorp Industries share price: what to watch after Friday dip as Feb 25 results near

Sembcorp Industries share price: what to watch after Friday dip as Feb 25 results near

7 February 2026
Sembcorp shares closed at S$6.05 on Friday, down 0.33%, as Singapore’s STI dropped 0.8%. Shareholders approved the A$6.5 billion Alinta Energy takeover on Jan 30, but the deal still faces regulatory and closing conditions. Sembcorp will release FY2025 results on Feb 25 before market open. Trading volume reached about 4.3 million shares.
Hongkong Land share price drops 4% despite fresh buyback — what investors watch next

Hongkong Land share price drops 4% despite fresh buyback — what investors watch next

7 February 2026
Hongkong Land shares fell 4.2% to US$8.18 in Singapore on Friday after the company disclosed a buyback of 170,000 shares at US$8.5252 each on Feb. 5, with plans to cancel them. The drop followed a volatile week marked by a new Singapore real estate fund launch and an expanded buyback programme. Investors are watching for the group’s annual results on March 5.
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