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ANDA filers that have submitted an application on or after Oct. 1 must pay $51,520 in user fees, according to the FDA’s 2013 generic drug user fee rates announced Wednesday.
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The International Trade Committee last month narrowly endorsed a mutual recognition deal that would allow EU-certified medicines to be exported to Israel and vice-versa without requiring additional certification for the importing country.
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The FDA has granted a priority review to Genentech’s sBLA for Avastin in people with metastatic colorectal cancer (mCRC) who have already been treated with chemotherapy plus Avastin.
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Lupin Pharmaceuticals received final approval for its levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg, from the FDA to market a generic version of Teva Pharmaceuticals’ Seasonale tablets.
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Macitentan, an investigational next-generation endothelin receptor antagonist for pulmonary arterial hypertension (PAH), met its efficacy endpoint and was well tolerated in a large clinical trial.
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Tonix Pharmaceuticals has completed dosing and plasma analysis of a pharmacokinetic (PK) study of its TNX-102 sublingual tablet, a formulation of cyclobenzaprine for bedtime use.
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A generic drugmaker has accused a British pharmaceutical company of putting profits ahead of patients in its efforts to block cheaper generic versions of Suboxone from coming on the U.S. market.
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German authorities ordered a recall Thursday of some batches of Novartis flu vaccine as a precautionary measure, after the company reported the appearance of small particles in the manufacturing process.
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AstraZeneca’s sales slumped by a bigger-than-expected 19 percent in the third quarter, underscoring the challenges confronting the drugmaker’s new chief executive, Pascal Soriot.
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