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RSS FeedPosted by Michael Wonder on 22 May 2019
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. ...
Posted by Michael Wonder on 22 May 2019
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% ...
Posted by Michael Wonder on 22 May 2019
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 ...
Posted by Michael Wonder on 22 May 2019
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 ...
Posted by Michael Wonder on 22 May 2019
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 ...
Posted by Michael Wonder on 22 May 2019
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 ...
Posted by Michael Wonder on 21 May 2019
FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations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 ...
Posted by Michael Wonder on 21 May 2019
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 ...
Posted by Michael Wonder on 21 May 2019
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 ...
Posted by Michael Wonder on 20 May 2019
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 ...
Posted by Michael Wonder on 20 May 2019
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. ...
Posted by Michael Wonder on 18 May 2019
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 ...
Posted by Michael Wonder on 18 May 2019
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 ...
Posted by Michael Wonder on 18 May 2019
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 ...
Posted by Michael Wonder on 16 May 2019
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 ...