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Eli Lilly's Kisunla wins FDA nod for new dosing with fewer side effects in Alzheimer'sThe benefit-risk balance is tipping more in favor of Eli Lilly’s Kisunla in early Alzheimer’s disease as the FDAapprovesa new dosing regimen of the drug with an improved safety profile. The new recom2025/7/10
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Southwest Airlines sues dozens of generic drugmakers for alleged price-fixing schemeSouthwest Airlines is buckling up to join in on a long-running legal battle surrounding an alleged price-fixing scheme involving generic medicines in the U.S. In a 730-page lawsuit filed in federal c2025/7/10
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Novartis' malaria drug for babies wins world-first approvalNovartis and a Swiss nonprofit have made history, scoring the world’s first approval for a medicine to treat babies who are infected with malaria. Switzerland’s health regulator hassigned offon Coa2025/7/2
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Achieve sparks up Omnicom pact, securing agency support for nicotine dependence drug launchAchieve Life Sciences hassigned upOmnicom to support the launch of nicotine dependence treatment cytisinicline, positioning the biotech to tap into capabilities at multiple agencies to reach patients2025/7/2
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Dizal to challenge J&J with FDA approval for lung cancer drug ZegfrovyEight years after it wasestablishedpartly by AstraZeneca, Dizal Pharmaceuticals has gained its first FDAapproval, winning an accelerated nod for Zegfrovy (sunvozertinib) to become the only U.S.-endor2025/6/25
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Amid $15B AstraZeneca partnership rumor, Summit needs $7.7B upfront to excite investors: analystAfter several PD-1xVEGF competitors forged alliances with Big Pharma players, Summit Therapeutics, the frontrunner in this hot cancer drug field, is reportedly seeking its own deal. AstraZeneca is in2025/6/17
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Fujifilm Biotechnologies takes lessons from Denmark as debut of massive NC cell culture facility loomsWith several high-profile drugmakers already lining up for manufacturing space, Fujifilm Biotechnologies is on the cusp of kicking off operations at a much-anticipated mega plant in North Carolina. M2025/6/17
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Regeneron, playing catch up with J&J and Pfizer, wins FDA approval for Lynozyfic in multiple myelomaAnother BCMA-targeted agent has arrived for the treatment of multiple myeloma. The new option, Regeneron’s linvoseltamab, haswon an FDA approvalfor treating myeloma patients who have received at leas2025/6/12
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Sandoz, on a $1.1B investment spree in Slovenia, breaks ground at new $440M biosimilar plantGeneric and biosimilar specialist Sandoz is strengthening its footprint in Slovenia, pledging $440 million to set up a new biosimilar facility for sterile product manufacturing some 24 miles from the2025/6/12
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FDA weighs regulatory action on argenx's Vyvgart Hytrulo amid reports of 'severe worsening' of diseaseThe FDA’s regular communications based on reports from its drug safety report database don’t always rattle investors’ cages. But that was not the case with a regulatory update Monday on argenx’s auto2025/6/10