Blog
RSS FeedPosted by Michael Wonder on 27 Jun 2018
Metastasis-free survival — a new end point in prostate cancer trials
27 June 2018 - Earlier this year, the FDA approved apalutamide, an androgen receptor inhibitor, for treatment of patients with non-metastatic ...
Posted by Michael Wonder on 27 Jun 2018
U.S. FDA grants priority review for Pfizer's new drug application for glasdegib in patients with previously untreated acute myeloid leukaemia
27 June 2018 - Submission based on data from randomised Phase 2 trial, which showed glasdegib in combination with chemotherapy nearly ...
Posted by Michael Wonder on 27 Jun 2018
Array BioPharma announces FDA approval of Braftovi (encorafenib) in combination with Mektovi (binimetinib)
27 June 2018 - Approval based on Phase 3 COLUMBUS trial which demonstrated nearly 15 months median progression-free survival. ...
Posted by Michael Wonder on 27 Jun 2018
Gottlieb calls on payers to share data to aid drug innovation
25 June 2018 - The FDA is working to modernize the clinical trial process in order to answer the right ...
Posted by Michael Wonder on 27 Jun 2018
Zemdri (plazomicin) approved by FDA for the treatment of adults with complicated urinary tract infections
26 June 2018 - Zemdri is a new treatment for patients with cUTI, including pyelonephritis, due to certain Enterobacteriaceae. ...
Posted by Michael Wonder on 26 Jun 2018
FDA grants priority review to Genentech’s baloxavir marboxil for the treatment of influenza
26 June 2018 - If approved, baloxavir marboxil would be the first oral, single-dose antiviral and the first medicine with a ...
Posted by Michael Wonder on 26 Jun 2018
FDA accepts supplemental biologics license application for Merck’s Keytruda (pembrolizumab) as adjuvant therapy in advanced melanoma
25 June 2018 - Application based on recurrence-free survival data from pivotal Phase 3 EORTC1325/KEYNOTE-054 trial. ...
Posted by Michael Wonder on 26 Jun 2018
Stemline Therapeutics announces completion of rolling BLA submission for Elzonris (tagraxofusp; SL-401) for the treatment of BPDCN
25 June 2018 - Stemline Therapeutics announced today that it has completed submission of a rolling biologics license application to the ...
Posted by Michael Wonder on 26 Jun 2018
Historic new drug application for the use of Scenesse in rare metabolic disorder EPP
25 June 2018 - Priority review requested to FDA. ...
Posted by Michael Wonder on 25 Jun 2018
As the drug industry eyes the burgeoning biosimilar market, its united front is starting to crack
25 June 2018 - The pharmaceutical industry’s massive lobbying operation has a well-earned reputation for maintaining a united front on ...
Posted by Michael Wonder on 25 Jun 2018
Imbruvica (ibrutinib) supplemental new drug application accepted for review by U.S. FDA with potential to broaden treatment use as a combination treatment option with rituximab in Waldenström's macroglobulinemia, a rare form of blood cancer
25 June 2018 - The filing is based on data from the Phase 3 iNNOVATE study, which suggest that IMBRUVICA plus ...
Posted by Michael Wonder on 25 Jun 2018
Statement by FDA Commissioner on the importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components
25 June 2018 - Over the past decade, we’ve seen a growing interest in the development of therapies derived from marijuana ...
Posted by Michael Wonder on 25 Jun 2018
FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
25 June 2018 - The U.S. FDA today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated ...
Posted by Michael Wonder on 23 Jun 2018
Nocdurna (desmopressin acetate) now approved by U.S. FDA as first sublingual tablet to treat nocturia due to nocturnal polyuria
21 June 2018 - Nocdurna sublingual tablets dissolve rapidly and have specific dosing designed for men and women to deliver a ...
Posted by Michael Wonder on 23 Jun 2018
Voyager Therapeutics announces FDA regenerative medicine advanced therapy designation granted for VY-AADC for the treatment of Parkinson’s Disease
21 June 2018 - Voyager Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for Voyager’s VY-AADC ...