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FDA disrupts Harmony's expansion dreams for excessive sleepiness drug Wakix with refusal letterHarmony Biosciences is facing more of a nightmare than sweet dreams on the road to securing a new use for its excessive daytime sleepiness (EDS) med Wakix. The FDA promptly shot down the company’s bi2025/2/18
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Bristol Myers Squibb notches overall survival win with Opdivo in preoperative NSCLCBristol Myers Squibb has bolstered its case for Opdivo to be used as a preoperative treatment for non-small cell lung cancer (NSCLC) as it hasdeliveredan overall survival (OS) edge when added to chem2025/2/13
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FDA signs off on Sanofi's insulin biosimilar, the first for Novo Nordisk's rapid-acting NovoLogMore than three years after approving two biosimilars referencing Sanofi’s long-acting insulin Lantus, the FDA has signed off on a rapid-acting insulin biosimilar for the first time. The agency has g2025/2/13
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With new FDA approval, GSK joins Pfizer in the 5-in-1 meningococcal vaccine ringPfizer’s two-year run with the only 5-in-1 meningococcal vaccine on the U.S. market has come to an end. Now, GSK is ready to play catch-up after nabbing its own FDA approval. The FDAapprovedthe Briti2025/2/11
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FDA approves Ono's rare tumor drug from $2.4B Deciphera buyoutA new FDA approval stands to give Daiichi Sankyo’s Turalio some company in a rare tumor type. Fellow Japanese drugmaker Ono Pharmaceutical haswon an FDA green lightfor vimseltinib to treat adul2025/2/11
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Sackler family, Purdue Pharma boost multistate opioid settlement to $7.4B in new agreementIn the latest twist in its efforts to wrap up years of high-profile opioid litigation, the billionaire family behind the now-bankrupt Purdue Pharma, the Sacklers, has come back from last year’s Supre2025/1/26
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Fierce Pharma Asia—Takeda R&D chief's new strategy; AZ, Daiichi's ADC nod; Fosun's failed Henlius buyTakeda's R&D chief explained the company's new investment priorities. AstraZeneca and Daiichi Sankyo's second antibody-drug conjugate has won its initial FDA approval in breast cancer. Fosun Phar2025/1/23
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Preeclampsia nonprofit puts new spin on old drug to close maternal health equity gapThe Preeclampsia Foundation hasfounda formula for closing the maternal health equity gap: Mix one part equity-forward preeclampsia education with one part low-dose aspirin prophylaxis and voilà, you2025/1/23
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Teva's multiple sclerosis stalwart Copaxone gets FDA boxed warning for anaphylaxis riskAfter years of legal wrangling surrounding Teva’s Copaxone, the latest hit to the lucrative multiple sclerosis drug comes in the form of a safety-related boxed warning. The label update, which also a2025/1/21
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Fosun's proposed Henlius Biotech buyout fails to pass shareholder voteFosun International’s proposed buyout of its partially owned subsidiary, Shanghai Henlius Biotech, has been quashed, with the necessary threshold of Henlius’ shareholders not voting in favor of the d2025/1/21