Amgen Inc. (AMGN) News
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AMGN News Highlights
- For AMGN, its 30 day story count is now at 22.
- Over the past 21 days, the trend for AMGN's stories per day has been choppy and unclear. It has oscillated between 1 and 4.
- DRUG, LUNG and TOP are the most mentioned tickers in articles about AMGN.
Latest AMGN News From Around the Web
Below are the latest news stories about AMGEN INC that investors may wish to consider to help them evaluate AMGN as an investment opportunity.
Coherus (CHRS) Stock Rallies on FDA Nod for Udenyca OnbodyThe FDA approves Coherus' (CHRS) Udenyca Onbody, an on-body injector presentation of Udenyca (pegfilgrastim-cbqv). Shares of the company rise on the news. |
Biotech Stock Roundup: BMY's KRTX and RYZB Acquisition, CYTK Surges on Study DataBristol Myers (BMY) and Cytokinetics (CYTK) are in the news on acquisition announcements and study updates, respectively. |
Amgen (AMGN) Surpasses Market Returns: Some Facts Worth KnowingIn the latest trading session, Amgen (AMGN) closed at $286.53, marking a +0.93% move from the previous day. |
FDA Rejects Amgen's (AMGN) NDA Seeking Full Nod for LumakrasPer the FDA, Amgen (AMGN) will need to complete an additional confirmatory study on Lumakras in certain lung cancer patients before February 2028 to secure full approval. |
FDA Wants Another Amgen Study on LumakrasAmgen will need to run another confirmatory study to win full FDA approval of its lung-cancer drug Lumakras. Amgen says the FDA, which granted conditional approval to the drug in 2021, has turned away its application seeking full approval and called on the company to complete the additional study by February 2028. An FDA advisory panel in October raised issues with Amgen's previous confirmatory study, citing problems with how the study was conducted, its small size and relatively minor extension of the time that patients lived without their cancers getting worse. |
Midday Movers: Intel's Israel Deal, Bristol-Myers Squibb Buys RayzeBioU.S. equities continued their pre-Christmas rally into the last week of 2023, with the Dow, S&P 500, and Nasdaq all up. |
UPDATE 2-US FDA turns down full approval of Amgen lung cancer drug LumakrasThe U.S. health regulator on Tuesday declined to grant traditional approval to Amgen's Lumakras for treating lung cancer patients with a specific gene mutation, although it kept the drug's existing accelerated approval status. The U.S. Food and Drug Administration (FDA) now requires data from an additional confirmatory study to support the drug's full approval, which will be completed no later than February 2028, the company said. Lumakras was approved by the FDA in 2021 under an accelerated pathway, with confirmatory data as a condition for gaining traditional approval. |
AMGEN PROVIDES REGULATORY UPDATE ON STATUS OF LUMAKRAS® (SOTORASIB)Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib). This review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The FDA also issued a new postmarketing requiremen |
Investors Heavily Search Amgen Inc. (AMGN): Here is What You Need to KnowRecently, Zacks.com users have been paying close attention to Amgen (AMGN). This makes it worthwhile to examine what the stock has in store. |
3 Biotech Stocks to Buy in the TradeSmith ‘Green Zone’It's now time to take a look at these three biotech stocks to buy, as each one is currently within TradeSmith's "Green Zone." |