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The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 8, 2011. The document announced the withdrawal of approval of 70 new drug applications (NDAs) and 97 abbreviated new drug applications from multiple applicants, effective July 8, 2011. The document contained the incorrect applicant information for NDA 018380. The correct applicant for NDA 018380 is Hospira, Inc. This document corrects that error.
pharmaphorum 08/19/2019 08:04
Celgene has scored a major regulatory win ahead of its proposed merger with Bristol-Myers Squibb, with the FDA backing its rare bone marrow cancer drug Inrebic.
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FiercePharmaManufacturing 08/14/2019 10:32
As pharma's earnings reports rolled out for the second quarter, market watchers pointed out a big positive: Growth rates, for many companies at least, were up. Way up. We've ranked the major players, from Regeneron's 20% sales hike to Teva's 8% drop.
More from FiercePharmaManufacturing: 08/13/2019 06:47
Condition : Healthy Participants Interventions : Drug: BMS-986165; Drug: Ritonavir Sponsor : Bristol-Myers Squibb Not yet recruiting.
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Seeking Alpha 08/08/2019 14:07
As the Celgene (CELG) acquisition heads towards closure, investors need to position themselves for owning shares in the new Bristol-Myers Squibb (BMY.
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Benzinga 08/04/2019 08:01
Insider buying can be an encouraging signal for potential investors. Insiders were buying shares last week in the wake of earnings reports. Two big drugmakers saw sizable insider purchases in the past week. Conventional wisdom says that insiders and 10% owners really only buy shares of a company for one reason -- they believe the stock price will rise and they want to profit from it.
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FierceMedicalDevices 08/01/2019 12:45
The phase 1/2 uses Bristol-Myers Squibb’s approved immuno-oncology drugs Opdivo and Yervoy and has been enrolling patients since May.
More from FierceMedicalDevices: 07/29/2019 22:52
Combination of regorafenib and nivolumab vs. regorafenib alone to be evaluated in patients with micro-satellite stable metastatic colorectal cancer. Companies plan indication-seeking trialWHIPPANY, N.J. & PRINCETON, N.J. & OSAKA, Japan--(BUSINESS WIRE)--Bayer, Bristol-Myers Squibb Company (NYSE: BMY) and Ono Pharmaceutical Co., Ltd. ("Ono") announced today the three companies have entered into a clinical collaboration agreement to evaluate the combination of Bayer’s kinase in...
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Big News Network (UAE) 07/29/2019 15:37
Bristol-Myers Squibb intends to close the Celgene transaction at the earliest possible date, which it currently expects to be by the end of 2019 or the beginning of 2020.
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Business Wire 07/26/2019 06:59
PRINCETON, N.J.--(BUSINESS WIRE)-- #BMS --BMS Receives Positive CHMP Opinion Recommending Approval of Empliciti® Plus Pomalidomide and Low-Dose Dexamethasone...
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