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Gets FDA Label Update for WINREVAIR Based on HYPERION Trial","url":"https://stock-news.laohu8.com/highlight/detail?id=2669614608","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2669614608?lang=en_us&edition=fundamental","pubTime":"2026-09-22 19:15","pubTimestamp":1790075715,"startTime":"0","endTime":"0","summary":"Merck  said Tuesday that the FDA approved an update to the US label for WINREVAIR, or sotatercept-csrk, based on data from the Phase 3 HYPERION trial in adults with pulmonary arterial hypertension diagnosed within the prior 12 months.The updated label includes efficacy and safety data for patients with newly diagnosed PAH who received WINREVAIR in addition to background therapy, it said.In HYPERION, WINREVAIR reduced the risk of clinical worsening events by 76% versus placebo, with a hazard ratio of 0.24, it added.The study enrolled adults with WHO functional class II or III PAH who were at intermediate to high risk of disease progression.The update also includes additional safety information and monitoring recommendations for hemoglobin and platelet levels, Merck 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says FDA approves update for U.S. product label for Winrevair","url":"https://stock-news.laohu8.com/highlight/detail?id=2669146630","media":"TIPRANKS","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2669146630?lang=en_us&edition=fundamental","pubTime":"2026-09-22 18:50","pubTimestamp":1790074233,"startTime":"0","endTime":"0","summary":"Merck (MRK) announced the U.S. FDA has approved an update to the U.S. product label for Winrevair for injection, 45mg, 60mg, based on the Phase 3 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FDA Approves Update to the Label for Winrevair to Include Data from the Phase 3 Hyperion Trial Evaluating Adults Recently Diagnosed with Pulmonary Arterial Hypertension","url":"https://stock-news.laohu8.com/highlight/detail?id=2669614575","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2669614575?lang=en_us&edition=fundamental","pubTime":"2026-09-22 18:48","pubTimestamp":1790074133,"startTime":"0","endTime":"0","summary":"BRIEF-U.S. FDA Approves Update To The Label For Winrevair To Include Data From The Phase 3 Hyperion Trial Evaluating Adults Recently Diagnosed With Pulmonary Arterial HypertensionSept 22 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Says Phase 3 Hyperion Trial Shows Winrevair Cuts PAH Clinical Worsening Risk 76%","url":"https://stock-news.laohu8.com/highlight/detail?id=2669452731","media":"Reuters","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2669452731?lang=en_us&edition=fundamental","pubTime":"2026-09-22 18:45","pubTimestamp":1790073940,"startTime":"0","endTime":"0","summary":"Merck says Phase 3 HYPERION trial shows WINREVAIR cuts PAH clinical worsening risk 76%Merck won a US label update for PAH drug Winrevair to add Phase 3 HYPERION efficacy and safety results.HYPERION re","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260922:nNDL4y9kWJ:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU2433249047.HKD","SG9999001176.USD","LU0130517989.USD","LU1989772840.SGD","LU2106854487.HKD","LU2361045086.USD","LU2461242641.AUD","IE0002141913.USD","LU0098860793.USD","PAWZ","RXL","LU0477156953.USD","LU0648001328.SGD","LU2324357040.USD","LU0289739699.SGD","SG9999015341.SGD","GDOC","LU0868494708.USD","LU0289739343.SGD","LU1974910355.USD","LU0006306889.USD","LU0203345920.USD","MRK","IE00BN8TJ469.HKD","LU1699723380.USD","SG9999015358.SGD","LU0211331839.USD","LU1037948541.HKD","LU0868494617.USD","IE00BJJMRZ35.SGD","LU0511384066.AUD","BK4534","LU0238689110.USD","IE00BBT3K403.USD","LU1585245621.USD","LU1291159041.SGD","IE00BLSP4452.SGD","BMED","IE00BFTCPJ56.SGD","IXJ","LU1066051811.HKD","LU1989771016.USD","LU2360032135.SGD","IE00B1BXHZ80.USD","LU0057025933.USD","LU1983299246.USD","LU0965509283.SGD","SG9999013999.USD","LU0124676726.USD","LU0234572021.USD","LU2125154778.USD","IE00BJT1NW94.SGD","LU2491049909.HKD","SG9999001176.SGD","BK4533","LU0265550359.USD","LU1941712348.USD","LU0472753341.HKD","LU0985320562.USD","LU2468319806.SGD","LU0265550946.USD","LU0203347892.USD","IE00BSNM7G36.USD","XLV","LU0965509010.AUD","LU0072461881.USD","LU1037948897.HKD","LU1093756168.USD","BK4007","LU0070302665.USD","LU1116320901.HKD","LU1066051225.USD","LU1934455277.USD","LU1917777945.USD","LU0861579265.USD","IE00B4R5TH58.HKD","LU1066053197.SGD","LU1057294990.SGD","IE000M9KFDE8.USD","LU1923622614.USD","SG9999014542.SGD","LU2357627491.SGD","LU0162691827.USD","LU0859254822.USD","FTXH","LU0823416689.USD","LU1066051498.USD","LU1093756325.SGD","LU0965509101.SGD","IE00BLSP4239.USD","IYH","LU0689626769.HKD","LU2491050154.USD","FHLC","PPH","BK4585","LU1941712264.USD","LU2112291526.USD","IE00B2B36J28.USD","LU0106261372.USD","LU0069063385.USD","LU0965508806.USD","BK4550","LU2125154935.USD","LU1116320737.USD","LU1430594728.SGD","SG9999014575.USD","LU0266013472.USD","LU1069347547.HKD","LU2491050071.SGD","VHT","SG9999001440.SGD","LU1032466523.USD","SG9999002224.SGD","SG9999014559.SGD","LU2125909247.SGD","LU2361044949.HKD","LU0942090050.USD","BK4516","SG9999014567.USD","LU2125909593.SGD","JDOC","BK4559","TRUH","LU0058720904.USD","LU1934455194.USD","IHE","LU1989772923.USD","LU0289961442.SGD","LU1162221912.USD","SG9999002232.USD","BK4588","LU0320765646.SGD","LU2023250843.SGD","IE0009355771.USD","SGXZ57979304.SGD","LU1023059063.AUD","LU2089984988.USD","LU1201861249.SGD","LU1035773651.USD","LU0432979614.USD","LU1571399168.USD","LU0122379950.USD","LU0980610538.SGD","LU0320765489.SGD","LU2361044865.SGD","LU1929549753.HKD","LU1934455863.HKD","LU2023250504.SGD","LU0208291251.USD","HRTS","LU0130102774.USD","LU1061106388.HKD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2669180160","title":"Nvidia Corp., Merck Share Gains Lead Dow's 425-Point Climb","url":"https://stock-news.laohu8.com/highlight/detail?id=2669180160","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2669180160?lang=en_us&edition=fundamental","pubTime":"2026-09-22 02:45","pubTimestamp":1790016300,"startTime":"0","endTime":"0","summary":"DJ NVIDIA Corp., Merck Share Gains Lead Dow's 425-Point ClimbThis article was automatically generated by MarketWatch using technology from Automated Insights.Behind positive momentum for shares of NVIDIA Corp. and Merck, the Dow Jones Industrial Average is up Monday afternoon.The Dow  is trading 425 points  higher, as shares of NVIDIA Corp.  and Merck  have contributed to the blue-chip gauge's intraday rally.NVIDIA Corp.'s shares have gained $5.49, or 2.5%, while those of Merck have risen $3.45, or 2.4%, combining for an approximately 53-point bump for the Dow.Also contributing significantly to the gain are Amgen , Goldman Sachs , and Amazon.com Inc. .A $1 move in any of the Dow's 30 components equates to a 5.94-point swing.Data source: Dow Jones Market Data, FactSet. Data compiled September 21, 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