Blog
RSS FeedPosted by Michael Wonder on 17 Aug 2017
FDA approves new treatment for adults with relapsed or refractory acute lymphoblastic leukaemia
17 August 2017 - The U.S. FDA today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or ...
Posted by Michael Wonder on 17 Aug 2017
Exelixis submits U.S. supplemental new drug application for Cabometyx (cabozantinib) for the treatment of previously untreated advanced kidney cancer
16 August 2017 - Cabometyx is the first therapy to demonstrate a clinically meaningful and statistically significant progression-free survival benefit over ...
Posted by Michael Wonder on 17 Aug 2017
Portola Pharmaceuticals announces AndexXa (andexanet alfa) biologics license application resubmission accepted for review by U.S. FDA
15 August 2017 - Portola Pharmaceuticals today announced that the U.S. FDA has found its resubmitted biologics license application for ...
Posted by Michael Wonder on 16 Aug 2017
What’s harder than making copycat biotech drugs? Selling them
15 August 2017 - Payer pacts, wary patients vex the market for biosimilar drugs. ...
Posted by Michael Wonder on 16 Aug 2017
Flimsy evidence behind many FDA approvals
16 August 2017 - Many drugs granted accelerated approval by the U.S. FDA lack clear evidence of safety and effectiveness, ...
Posted by Michael Wonder on 16 Aug 2017
Lipocine announces FDA acknowledgement of Tlando ("LPCN 1021") NDA resubmission; PDUFA goal date, 8 February 2018
14 August 2017 - Lipocine today announced that the U.S FDA has acknowledged receipt of the company's new drug application ...
Posted by Michael Wonder on 15 Aug 2017
Characteristics of pre-approval and post-approval studies for drugs granted accelerated approval by the US Food and Drug Administration
15 August 2017 - The FDA granted accelerated approval to 22 drugs for 24 indications. ...
Posted by Michael Wonder on 13 Aug 2017
A cancer conundrum: too many drug trials, too few patients
12 August 2017 - With the arrival of two revolutionary treatment strategies, immunotherapy and personalised medicine, cancer researchers have found ...
Posted by Michael Wonder on 12 Aug 2017
Gilead announces US FDA priority review designation for fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide for treatment of HIV
10 August 2017 - Final FDA Decision Anticipated by 12 February 2018. ...
Posted by Michael Wonder on 10 Aug 2017
Setting the record straight on FDA approvals in oncology
7 August 2017 - The Research Letter, “Quality of Life, Overall Survival and Costs of Cancer Drugs Approved Based on Surrogate ...
Posted by Michael Wonder on 10 Aug 2017
To speed access to compassionate use, look beyond the FDA
10 August 2017 - In mid-July, the nonpartisan research arm of the federal government, the Government Accountability Office, released its long-awaited ...
Posted by Michael Wonder on 10 Aug 2017
FDA issues a complete response letter on CCP-08 NDA
7 August 2017 - Vernalis announced today that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 09 Aug 2017
FDA grants priority review and breakthrough therapy designation for Zelboraf (vemurafenib) in Erdheim-Chester disease with BRAF V600 mutation
7 August 2017 - There are currently no FDA-approved treatments for Erdheim-Chester disease, a rare blood disease. ...
Posted by Michael Wonder on 09 Aug 2017
Valeant Pharmaceuticals receives complete response letter from the FDA for latanoprostene bunod ophthalmic solution, 0.024% NDA
7 August 2017 - Valeant Pharmaceuticals today announced it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 08 Aug 2017
FDA approves Medicines360's sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to four years
7 August 2017 - Approval offers women additional flexibility for pregnancy prevention. ...