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Lilly, BI approach CV-benefit label change for SGLT2 med JardianceEli Lilly ($LLY) andBoehringer Ingelheimare one step closer to an important label change for SGLT2 contenderJardiance. The FDA has accepted a supplemental New Drug Application that, if approved, will2016/1/28
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FDA approves Allergan's Botox to treat lower limb spasticity in adultsThe US Food and Drug Administration (FDA) has granted approval for Allergan's Botox (onabotulinumtoxinA) to treat lower limb spasticity in adults to decrease the severity of increased muscle stiffness2016/1/27
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Amgen receives FDA approval for Kyprolis combination therapy to treat multiple myelomaThe US Food and Drug Administration (FDA) has granted approval for Amgens' Kyprolis (carfilzomib) combination therapy to treat patients with relapsed or refractory multiple myeloma. Amgen has receive2016/1/27
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J&J loses bid to dismiss false advertising lawsuit over baby productsJohnson & Johnson ($JNJ) was hoping to put a marketing case around its Bedtime Products for babies to rest, but a federal judge isn't having it. U.S. District Judge Elaine Bucklo has shot down the2016/1/26
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BMS' Opdivo evens the score in melanoma with two new FDA green lightsThanks to anFDAdecision over the weekend, Bristol-Myers Squibb's ($BMY) immunotherapyOpdivohas caught back up to Merck's ($MRK)Keytrudain melanoma. And it won a new combination approval from theFDAto2016/1/26
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Pfizer's Ibrance clears first hurdle to early access in U.K.Pfizer's ($PFE) new cancer standout,Ibrance, has taken its first step toward joining the U.K.'s Early Access to Medicines program, winning the "promising innovative medicine" tag from the country's Me2016/1/25
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FDA bans products from China plant used by Big Pharma playersA Chinese drug-ingredient maker who has produced active ingredients for some of the big guns in pharma now faces an FDA ban in the U.S. The agency added Zhejiang Hisoar Pharmaceutical to its import al2016/1/25
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Acquisition of Pharmaceutical Sugar Spheres Product Line from Paulaur Corporation19th January 2016 Subject: Acquisition of Pharmaceutical Sugar Spheres Product Line from Paulaur Corporation Dear Customer: We are pleased to announce that effective 18th January 2016, Colorcon,2016/1/22
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US FDA grants priority review to Eisai’s new drug application for anticancer drug lenvatinibThe US Food and Drug Administration (FDA) has granted priority review status to the supplemental new drug application (sNDA) submitted by Eisai for its anticancer agent lenvatinib mesylate, as a treat2016/1/20
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US FDA approves Cosentyx for ankylosing spondylitis and psoriatic arthritis treatmentSwiss drug maker Novartis has secured approvals from the US Food and Drug Administration (FDA) for injectable medication Cosentyx for two new indications, which can now be used to treat patients havin2016/1/20