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RSS FeedPosted 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FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations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 ...
Posted by Michael Wonder on 16 May 2019
FDA approves first anticoagulant (blood thinner) for paediatric patients to treat potentially life-threatening blood clots
16 May 2019 - The U.S. FDA today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of ...
Posted by Michael Wonder on 15 May 2019
Hospital drug making venture picks antibiotics as first products
15 May 2019 - Nonprofit Civica Rx plans to begin distributing vancomycin hydrochloride and daptomycin before the end of September. ...
Posted by Michael Wonder on 15 May 2019
Drug prices in TV ads: how transparent are they?
15 May 2019 - A website launched by pharmaceutical giant Eli Lilly earlier this year leads with a daunting statement ...
Posted by Michael Wonder on 15 May 2019
AbbVie announces US FDA approval of Venclexta (venetoclax) as a chemotherapy-free combination regimen for previously untreated chronic lymphocytic leukaemia patients
15 May 2019 - FDA reviewed the submission under the real-time oncology review pilot program. ...
Posted by Michael Wonder on 15 May 2019
Lipocine announces Tlando NDA PDUFA action date of 9 November 2019
14 May 2019 - Lipocine today announced that the U.S.FDA has accepted its new drug application for Tlando as testosterone ...