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US regulators on track for another strong year of approvals
epvantage
July 27, 2018
A nurturing regulatory environment is one of biopharma’s strongest tailwinds, and there are few signs of this petering out.
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Patient death prompts FDA hold on Mersana’s lead cancer ADC
fiercebiotech
July 26, 2018
Another antibody-drug conjugate has been stalled by concerns over safety. The FDA has placed a partial hold on Mersana’s lead candidate XMT-1522 after a patient death in a phase 1 trial, causing its shares to plunge.
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FDA approves AbbVie’s Orilissa for endometriosis pain
pharmaceutical-technology
July 26, 2018
The US Food and Drug Administration (FDA) has approved AbbVie and Neurocrine Biosciences’ drug Orilissa (elagolix) for women with moderate to severe endometriosis pain.
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FDA Approves Magnetic System for Guiding Lymph Node Biopsies
drugs
July 26, 2018
A magnetic system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy has been approved by the U.S. Food and Drug Administration.
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Samsung BioLogics Receives the first FDA DP approval
biospectrumasia
July 26, 2018
Samsung BioLogics has 16 total global approvals for manufacturing Drug Substance in Plant 1 and 2
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Boosting the safety of bulk drug substances is aim of FDA measures
europeanpharmaceuticalreview
July 26, 2018
Boosting the safety of compounded drugs is the aim of new plan from the US Food and Drug Administration (FDA), which has unveiled a series of measures.
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FDA Approves Orilissa
drugs
July 25, 2018
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the U.S. Food and Drug Administration (FDA) approved Orilissa (elagolix), the first and only oral gonad
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Lupin gets tentative FDA approval for Tadalafil tablets
expressbpd
July 25, 2018
The company will market a generic version of Eli Lilly and Company’s Cialis tablets.
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Bayer to stop Essure sales at year-end
biospectrumasia
July 24, 2018
The birth control treatment is alleged to have harmed thousands of women in the past two decades.
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Statement from FDA Commissioner to Improve Access to OTC Drugs
americanpharmaceuticalreview
July 24, 2018
At the FDA, we’re continuing to look at ways we can foster greater access to the medicines that help keep people healthy.