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RSS FeedPosted by Michael Wonder on 26 May 2018
Eisai and Merck provide update on supplemental new drug application for lenvatinib in first-line unresectable hepatocellular carcinoma
24 May 2018 - Eisai and Merck announced today that the U.S. FDA has extended the action date for the ...
Posted by Michael Wonder on 25 May 2018
Recro Pharma receives complete response letter from the FDA
24 May 2018 - Recro Pharma today announced it has received a complete response letter from the U.S. FDA Office ...
Posted by Michael Wonder on 25 May 2018
U.S. FDA grants fast track designation for Krystal Biotech’s KB103 for the treatment of dystrophic epidermolysis bullosa
24 May 2018 - Krystal Biotech today announces that the U.S. FDA has granted fast track designation to KB103 for ...
Posted by Michael Wonder on 25 May 2018
BioMarin receives standard approval for Palynziq (pegvaliase-pqpz) injection for treatment of adults with phenylketonuria, a rare enetic Disease
24 May 2018 - First enzyme therapy to treat phenylketonuria. ...
Posted by Michael Wonder on 24 May 2018
Teva confirms September PDUFA date for fremanezumab
23 May 2018 - May 23, 2018-- Teva Pharmaceutical Industries today confirmed that the U.S. FDA has extended the goal date ...
Posted by Michael Wonder on 24 May 2018
FDA accepts supplemental biologics license application and grants priority review for prophylactic and paediatric use for Bio Products Laboratory's Coagadex (coagulation factor X, human) for treatment of hereditary factor X deficiency
23 May 2018 - FDA previously granted Coagadex orphan drug designation for the treatment of hereditary factor X deficiency. ...
Posted by Michael Wonder on 24 May 2018
FDA to review Zynquista (sotagliflozin) as potential treatment for type 1 diabetes
22 May 2018 - The U.S. FDA has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). The investigational oral treatment would be ...
Posted by Michael Wonder on 24 May 2018
FDA grants breakthrough therapy designation to Lenti-D for the treatment of cerebral adrenoleukodystrophy
23 May 2018 - bluebird bio today announced that the U.S. FDA has granted breakthrough therapy designation to Lenti-D for ...
Posted by Michael Wonder on 24 May 2018
FDA grants breakthrough therapy designation for tafamidis for the treatment of patients with transthyretin cardiomyopathy
23 May 2018 - Pfizer announced today that tafamidis received breakthrough therapy designation from the US FDA for the treatment ...
Posted by Michael Wonder on 23 May 2018
Rationale, opportunities, and reality of biosimilar medications
24 May 2018 - Biosimilars work like established therapeutic agents but have some dissimilarities based on differences in production. ...
Posted by Michael Wonder on 23 May 2018
Sun Pharma announces USFDA approval of Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer in combination with methylprednisolone
23 May 2018 - Sun Pharma had acquired Yonsa from Churchill Pharmaceuticals and will commercialise Yonsa in the U.S. ...
Posted by Michael Wonder on 23 May 2018
‘Right to try’ legislation heads to the White House
22 May 2018 - The House on Tuesday passed “right to try” legislation that would allow people with life-threatening illnesses ...
Posted by Michael Wonder on 23 May 2018
Gene therapies that could transform diseases get easier FDA path
23 May 2018 - Haemophilia treatments could be first under proposed method. ...
Posted by Michael Wonder on 22 May 2018
Janssen questions literature review on biosimilar switching studies as authors defend it
22 May 2018 - Three employees of Johnson & Johnson’s Janssen Pharmaceuticals, which has not publicly disclosed that it is ...
Posted by Michael Wonder on 22 May 2018
Make drugs cheaper by encouraging generics
22 May 2018 - The FDA is pushing in that direction. Congress could do much more. ...