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Regulatory Intelligence & Drug Approvals1 month agoBsUFA IV: Fiscal Years 2028-2032
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022.
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Regulatory Intelligence & Drug Approvals1 month agoKyverna steps closer to FDA-first CAR T for an autoimmune condition with durability data
Kyverna Therapeutics' miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application,...
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Regulatory Intelligence & Drug Approvals1 month agoFDA Approves Once-Weekly Insulin for Type 2 Diabetes Mellitus
The U.S. Food and Drug Administration has approved Onswik (insulin efsitora alfa-gobe) injection, a long-acting insulin analog, as an adjunct to diet and exercise to improve...
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: Pharmalittle: We’re reading about the FDA commissioner nominee, a Lilly partnership in China, and more
During a Senate hearing today, Heidi Overton, the nominee to lead the FDA, plans to emphasize the need for speed and efficiency to compete with China
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Regulatory Intelligence & Drug Approvals1 month agoEli Lilly’s weekly insulin shot cleared by FDA, setting up another front in Novo rivalry
The weekly insulin Onswik will now be available to U.S. patients after initial approvals in Europe, Mexico and Japan.
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Regulatory Intelligence & Drug Approvals1 month agoLilly’s rival to Novo’s new Awiqli insulin gets FDA approval
The FDA has approved Eli Lilly's once-weekly basal insulin product Onswik, setting up a market tussle with Novo's recently launched Awiqli.
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Regulatory Intelligence & Drug Approvals1 month ago
GSK slammed for ‘grossly misleading’ and ‘totally unacceptable’ behavior
GSK showed a “totally unacceptable” lack of transparency in its interactions with the PMCPA, the U.K. self-regulatory body ruled.
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Regulatory Intelligence & Drug Approvals1 month ago
Elevar wins FDA nod for bile duct cancer drug Lyrfigtu, a first for a Korean firm
The FDA has greenlighted Elevar’s FGFR2-selective inhibitor Lyrfigtu in bile duct cancer, making it the first novel cancer drug from a Korean company to secure FDA...
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Regulatory Intelligence & Drug Approvals1 month ago
Otsuka JV recalls one lot of sodium chloride over labeling issue
Otsuka ICU Medical, a joint venture from Japan’s Otsuka Pharmaceutical Factory, issued a voluntary recall of one lot of 0.9% sodium chloride injection for IV due...
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Regulatory Intelligence & Drug Approvals1 month agoGrail cancer test gets lukewarm backing from FDA adcomm
FDA expert advisors voted in favour of Grail's Galleri blood test for detecting multiple cancers, but some expressed misgivings about its efficacy.
Opentrons Raises $40M in Series E to Expand Its Robotics, Software, Data Infrastructure
100 Million-Cell AI-Ready Dataset with Single-Cell and Proteomic Data Created by Parse and Nomic
No Nonsense: David Liu Lauds Progress in Disease-Agnostic Gene Editing at ESGCT
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
