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Roche touts head-to-head data for Xolair against oral immunotherapy for treating food allergiesA year after the FDA blessed Roche and Novartis’ Xolair (omalizumab) as the first medicine to reduce allergic reactions that can occur from accidental exposure to certain foods, the companies have pr2025/2/25
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Fierce Pharma Asia—Novo Nordisk's fraud accusation; AstraZeneca's China deal; Ono's FDA nodNovo Nordisk alleges Singaporean biotech KBP Biosciences made misleading statements before the two firms inked a licensing deal worth up to $1.3 billion. AstraZeneca is buying out its roxadustat part2025/2/20
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Canada locks down an initial 500K doses of GSK's bird flu vaccineFollowing similar deals in countries like the U.S. and the U.K., Canada is bolstering its stockpile of bird flu vaccines and rolling out new guidance to ensure the shot reaches those who need it most2025/2/20
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Merck, plaintiff agree to hit the brakes on Gardasil trial in CaliforniaLawsuits surrounding Merck's HPV vaccine Gardasil have been piling up for years now, but they've garnered increased public attention lately after HHS Secretary Robert F. Kennedy Jr.'s links to the li2025/2/18
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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