Agile Therapeutics announces FDA acceptance of the NDA resubmission of Twirla

22 May 2019 - FDA assigns Prescription Drug User Fee Act goal date of 16 November 2019. ...

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FDA approves Sorilux for adolescent plaque psoriasis

22 May 2019 - Mayne Pharma is pleased to announce that the US FDA has approved Sorilux (calcipotriene) foam, 0.005% ...

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House Committee proposes 6% increase in FDA funding for FY 2020

22 May 2019 - The House Appropriations Committee on Wednesday released a draft fiscal year 2020 funding bill for the ...

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U.S. FDA grants priority review of Invokana (canagliflozin) sNDA for the treatment of chronic kidney disease in patients with type 2 diabetes

22 May 2019 - Application was submitted in March 2019 based on landmark phase 3 CREDENCE renal outcomes study published in ...

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Lilly selling half-price version of popular Humalog insulin

22 May 2019 - A half-price version of Eli Lilly's popular Humalog insulin is now available, following the company's promise in ...

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PolyPid receives a second QIDP designation for D-PLEX100 in abdominal surgery

21 May 2019 - PolyPid Ltd announced today that the United States FDA has granted a second qualified infectious disease product ...

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FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations

21 May 2019 - A week after finalizing guidance on developing interchangeable biosimilars, the US FDA has drafted guidance for ...

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Google sister company Verily is teaming with big pharma on clinical trials

21 May 2019 - Pharma companies are looking to work with Verily, which is part of the Alphabet umbrella, as they ...

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Framework for the regulation of regenerative medicine products

21 May 2019 - The U.S. FDA has published four final guidance documents that are part of a comprehensive policy framework ...

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UCB announces Nayzilam (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the US

19 May 2019 - Nayzilam allows for administration by a non-healthcare professional in patients actively seizing when and where a seizure ...

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FDA's strengthened global inspection program helps ensure generic drug safety

17 May 2019 - Consumers must have confidence in the safety and quality of generic medicines.  ...

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Athersys announces fast track designation from FDA for MultiStem program for acute respiratory distress syndrome

14 May 2019 - Athersys announced today that its clinical program evaluating MultiStem cell therapy for the treatment of acute respiratory ...

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Agile Therapeutics resubmits new drug application for its transdermal low-dose contraceptive patch, Twirla

17 May 2019 - Agile Therapeutics today announced it has resubmitted to the U.S. FDA the new drug application for its ...

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U.S. FDA approves Gattex (teduglutide) for children 1 year of age and older with short bowel syndrome

17 May 2019 - Gattex is the only glucagon-like peptide-2 analogue approved that improves intestinal absorption in patients with SBS who ...

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Instalment payments could be used across gene therapy space, Spark CEO says

16 May 2019 - In a fireside chat at the recently concluded Veeva Summit in Philadelphia, Jeff Marrazzo said payment over ...

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