The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
Merrimack announced the Company is discontinuing development of MM-310, its antibody-directed nanotherapeutic for the treatment of solid tumors.
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Daiichi Sankyo announced the FDA has extended the review period for the NDA of quizartinib currently under Priority Review for the treatment of adult ...
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NanoViricides has requested a pre-IND meeting with the US FDA, as it progresses its lead drug candidate towards human clinical trials.
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The FDA issued two final guidances for industry to help product sponsors understand the FDA’s thinking about preventive treatments for HIV as well as ...
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The FDA approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women.
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Eli Lilly and Company announced its study of CYRAMZA® met its primary endpoint of PFS, demonstrating a statistically significant improvement in the ...
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Eli Lilly and Company announced the FDA has granted Priority Review for its sBLA for Emgality® injection for the preventive treatment of episodic ...
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Wednesday, March 06, 2019
The FDA has approved Spravato nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have treatment-...
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CytoDyn announced that the FDA has reviewed and accepted CytoDyn’s request and plan to submit on a rolling basis its planned Biologics License ...
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Tuesday, February 26, 2019
NanoViricides has reached an agreement on the terms of the license for the drug development against VZV, the virus that causes chickenpox in children ...
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Monday, February 25, 2019
Novartis is exercising its option to license the rights to develop and commercialize TQJ230, an investigational agent previously known as AKCEA-APO(a)...
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Tuesday, February 19, 2019
Inhibrx announced dosing has begun in a Phase 1 dose-escalation clinical trial of INBRX-105.
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Friday, February 15, 2019
Atox Bio announced the appointment of Robert Greif as Chief Commercial Officer.
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Friday, February 15, 2019
Bayer has exercised its option to obtain the exclusive licensing rights for the global development and commercialization, for Vitrakvi and BAY 2731954...
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Friday, February 15, 2019
The FDA has issued a final rule under section 503A of the FDCA, placing, for the first time, six bulk drug substances on the list of substances that ...
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