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RSS FeedPosted 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. ...
Posted by Michael Wonder on 22 May 2018
Lilly's Taltz (ixekizumab) receives the first U.S. FDA approval for label update to include data for psoriasis involving the genital area
22 May 2018 - The label update is effective immediately in the United States. ...
Posted by Michael Wonder on 22 May 2018
Utility receives qualified infectious disease product designation from the U.S. FDA
21 May 2018 – Utility Therapeutics today announced that the U.S. FDA has designated both mecillinam (injectable) and pivmecillinam (oral ...
Posted by Michael Wonder on 22 May 2018
GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma
21 May 2018 - GSK today announced it has received approval from the US FDA for the use of Arnuity Ellipta ...
Posted by Michael Wonder on 22 May 2018
Harmony Biosciences receives breakthrough therapy and fast track designations for pitolisant
21 May 2018 - Expanded access program for pitolisant is open and patients are being enrolled. ...