Blog
RSS FeedPosted by Michael Wonder on 06 Feb 2019
FDA grants priority review for Daiichi Sankyo’s new drug application for CSF1R inhibitor pexidartinib for treatment of patients with TGCT, a rare, debilitating tumour
6 February 2019 - If approved by the FDA, pexidartinib would be the first and only approved therapy for tenosynovial giant ...
Posted by Michael Wonder on 05 Feb 2019
FDA accepts for review new drug application for Merck’s investigational combination of imipenem/cilastatin and relebactam, and supplemental NDA for Zerbaxa (ceftolozane and tazobactam)
5 February 2019 - Merck today announced that the U.S. FDA has accepted for review regulatory filings for two antibacterial ...
Posted by Michael Wonder on 05 Feb 2019
Pain Therapeutics announces feedback from recent meeting with FDA on Remoxy
5 February 2019 - Going Forward, We Will Be Silent Regarding Future Expectations for REMOXY. ...
Posted by Michael Wonder on 05 Feb 2019
US FDA grants breakthrough therapy designation for potential next-generation RSV medicine MEDI8897
5 February 2019 - Designation based on positive primary analysis of the Phase IIb trial that demonstrated the safety and ...
Posted by Michael Wonder on 05 Feb 2019
Roche submits supplemental biologics license application to the US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neo-adjuvant treatment
5 February 2019 - Roche’s application is being reviewed under the US FDA's real-time oncology review and Assessment Aid pilot programmes. ...
Posted by Michael Wonder on 05 Feb 2019
SK Life Science announces FDA acceptance of NDA submission for cenobamate, an investigational anti-epileptic drug
4 February 2019 - SK Life Science announced today that the U.S. FDA has accepted the filing of its new ...
Posted by Michael Wonder on 05 Feb 2019
Pharnext announces FDA fast track designation for Pleodrug PXT3003 for the treatment of Charcot-Marie-Tooth disease type 1A
4 February 2019 - Pharnext announced today that the U.S. FDA has granted fast track designation for the development of PXT3003 ...
Posted by Michael Wonder on 04 Feb 2019
This once free drug for a rare condition now costs $375,000
4 February 2019 - Firdapse, a drug used for treatment of a rare neurological disorder that affects one in 100,000 ...
Posted by Michael Wonder on 04 Feb 2019
Evolus receives FDA approval for Jeuveau prabotulinumtoxina-xvfs for injection
1 February 2019 - Jeuveau is the first aesthetic-only neurotoxin approved in the U.S; launch planned for spring 2019. ...
Posted by Michael Wonder on 04 Feb 2019
Alkermes receives complete response letter from U.S. FDA for ALKS 5461 new drug application
1 February 2019 - Alkermes today announced that it received a complete response letter from the U.S. FDA regarding its ...
Posted by Michael Wonder on 01 Feb 2019
AVEO Oncology announces NDA timing update
31 January 2019 - AVEO Oncology today announced that it has accepted the recommendation of the U.S. FDA not to ...
Posted by Michael Wonder on 01 Feb 2019
Sunovion receives complete response letter from FDA for apomorphine sublingual film (APL-130277)
30 January 2019 - Sunovion Pharmaceuticals announced today that the U.S. FDA issued a complete response letter for the new ...
Posted by Michael Wonder on 31 Jan 2019
FDA expands Lilly's Alimta (pemetrexed) label with combination of Keytruda (pembrolizumab) and platinum chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer
31 January 2019 - New approval based on Phase 3 KEYNOTE-189 results. ...
Posted by Michael Wonder on 31 Jan 2019
A review of patient reported outcomes labelling for oncology drugs approved by the FDA and the EMA (2012-2016)
31 January 2019 - In recent years, the FDA has granted patient-reported outcome labelling to very few oncology drugs. ...
Posted by Michael Wonder on 31 Jan 2019
Innate Pharma receives FDA fast track designation for IPH4102 in relapsed or refractory Sézary syndrome
29 January 2019 - Fast track designation is based on the evaluation of Phase I results demonstrating strong clinical activity, favourable ...