Blog
RSS FeedPosted by Michael Wonder on 26 Jul 2018
Drug companies can’t game paediatric drug laws anymore
26 July 2018 - Drug companies can’t avoid including kids in certain clinical studies now that the FDA has finally ...
Posted by Michael Wonder on 25 Jul 2018
FDA publishes list of surrogate outcomes used in drug approvals
25 July 2018 - The US FDA on Wednesday published a list of surrogate outcomes to help inform drug developer ...
Posted by Michael Wonder on 25 Jul 2018
Scientist invented a new pathway to approve biosimilars, and the FDA is listening
25 July 2018 - In an extraordinary move, the FDA has withdrawn the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity,” ...
Posted by Michael Wonder on 24 Jul 2018
Apellis Pharmaceuticals’ APL-2 receives fast track designation from FDA for the treatment of patients with geographic atrophy
24 July 2018 - Apellis Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 24 Jul 2018
AbbVie receives U.S. FDA approval of Orilissa (elagolix) for the management of moderate to severe pain associated with endometriosis
24 July 2018 - FDA approval is supported by the largest endometriosis Phase 3 study program conducted to date. ...
Posted by Michael Wonder on 23 Jul 2018
Allergan receives FDA fast track designation for AGN-241751 for the treatment of major depressive disorder
23 July 2018 - Phase 2 clinical study underway. ...
Posted by Michael Wonder on 23 Jul 2018
Precision medicine success hinges on diagnostics' clinical utility
23 July 2018 - The companion diagnostic plays a significant role in precision medicine. ...
Posted by Michael Wonder on 23 Jul 2018
Aerie Pharmaceuticals announces early notification of FDA acceptance of NDA submission for Roclatan (netarsudil/latanoprost ophthalmic solution)
23 July 2018 - Aerie Pharmaceuticals today reported that it has received the “Day 74” notification from the U.S. FDA earlier ...
Posted by Michael Wonder on 23 Jul 2018
BeiGene announces plan to pursue accelerated approval in the U.S. of BTK inhibitor zanubrutinib in Waldenström macroglobulinaemia
22 July 2018 - Fast track designation granted by U.S. FDA. ...
Posted by Michael Wonder on 22 Jul 2018
US FDA approves Krintafel (tafenoquine) for the radical cure of P. vivax malaria
20 July 2018 - First single-dose medicine to prevent the relapse of P. vivax malaria marks a major contribution towards ...
Posted by Michael Wonder on 20 Jul 2018
Sellas receives fast track designation from FDA for galinpepimut-S for the treatment of patients with multiple myeloma
20 July 2018 - Sellas Life Sciences today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 20 Jul 2018
U.S. FDA approves Pfizer's biosimilar Nivestym (filgrastim-aafi)
20 July 2018 - Nivestym, a biosimilar to Neupogen (filgrastim), is Pfizer's fourth biosimilar to be approved by the FDA. ...
Posted by Michael Wonder on 20 Jul 2018
Statement from FDA Commissioner on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse
20 July 2018 - One of the ways that the U.S. FDA is working to address the opioid epidemic is ...
Posted by Michael Wonder on 20 Jul 2018
FDA provides scientific and regulatory clarity for generic drug developers through the issuance of 43 new or revised product-specific guidance documents, including hard-to-copy complex generics and abuse-deterrent formulations of opioids
20 July 2018 - The U.S. FDA today announced a new batch of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 20 Jul 2018
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukeamia who have a certain genetic mutation
20 July 2018 - The U.S. FDA today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or ...