Blog
RSS FeedPosted by Michael Wonder on 17 May 2018
Myonexus Therapeutics receives FDA rare paediatric drug designation for pioneering treatment of limb girdle muscular dystrophy Type 2E
16 May 2018 - Rare paediatric disease designation for MYO-101 program reflects compelling data and enables priority eeview voucher eligibility. ...
Posted by Michael Wonder on 17 May 2018
Castle Creek Pharmaceuticals receives FDA rare paediatric disease designation for diacerein 1% ointment for epidermolysis bullosa
16 May 2018 - Castle Creek Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation for diacerein ...
Posted by Michael Wonder on 07 May 2018
FDA grants priority review to Roche’s cancer immunotherapy Tecentriq (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer
7 May 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 03 May 2018
Cellectar receives rare paediatric disease designation for CLR 131 to treat neuroblastoma
2 May 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to the ...
Posted by Michael Wonder on 01 May 2018
FDA grants priority review to Merck’s sBLA for Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy based on results from Phase 3 KEYNOTE-189 trial as first-line treatment of metastatic non-squamous NSCLC
30 April 2018 - U.S. FDA has set a PDUFA date of 23 September 2018. ...
Posted by Michael Wonder on 30 Apr 2018
FDA to conduct priority review of cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma
30 April 2018 - The U.S. FDA has accepted priority review the biologics license application for cemiplimab for the treatment ...
Posted by Michael Wonder on 23 Apr 2018
Abeona announces FDA grants RMAT designation to ABO-102 gene therapy in MPS IIIA
23 April 2018 - First gene therapy using AAV approach granted regenerative medicine advanced therapy designation. ...
Posted by Michael Wonder on 18 Apr 2018
U.S. FDA accepts supplemental biologics license application for Opdivo (nivolumab) in previously treated patients with small cell lung cancer and grants priority review
18 April 2018 - Bristol-Myers Squibb today announced that the U.S. FDA has accepted for priority review its supplemental biologics ...
Posted by Michael Wonder on 09 Apr 2018
FDA accepts new drug application for duvelisib and grants priority review
9 April 2018 - Application seeks full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic ...
Posted by Michael Wonder on 04 Apr 2018
Paratek’s new drug applications for oral and intravenous omadacycline accepted for priority review by FDA
4 April 2018 - PDUFA action date in October 2018. ...
Posted by Michael Wonder on 27 Mar 2018
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for previously treated patients with MSI-H or dMMR metastatic colorectal cancer for priority review
27 March 2018 - The FDA also granted the Opdivo plus Yervoy combination breakthrough therapy designation for this potential indication. ...
Posted by Michael Wonder on 20 Mar 2018
Amplyx Pharmaceuticals receives fourth “Qualified Infectious Disease Product” designation from the FDA for APX001
12 March 2018 - Designation granted for treatment of cryptococcosis provides priority review, fast-track status and five additional years of ...
Posted by Michael Wonder on 20 Mar 2018
U.S. FDA grants priority review for a supplemental new drug application for Xtandi (enzalutamide) in non-metastatic castration-resistant prostate cancer
19 March 2018 - Application seeks to expand the indication of Xtandi to include men with non-metastatic castration-resistant prostate cancer. ...
Posted by Michael Wonder on 16 Mar 2018
Abeona Therapeutics receives FDA rare paediatric disease designation for ABO-202 gene therapy program in CLN1 disease
15 March 2018 - Company’s fourth gene therapy program to receive rare paediatric disease designation, enabling priority review voucher. ...
Posted by Michael Wonder on 14 Mar 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytuda (pembrolizumab) for treatment of advanced cervical cancer
13 March 2018 - First filing acceptance for an anti-PD-1 therapy in cervical cancer. ...