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RSS FeedPosted by Michael Wonder on 16 Jun 2016
Shire and Kamada announce FDA approval of expanded label for self-infusion of Glassia for the treatment of emphysema due to severe AAT deficiency
15 June 2016 - Glassia is the only FDA approved alfa-1 antitrypsin (human) augmentation treatment that patients can self-infuse at home. ...
Posted by Michael Wonder on 15 Jun 2016
Marathon Pharmaceuticals announces submission of deflazacort new drug application to the FDA
14 June 2016 - Deflazacort has fast track status, orphan drug designation and rare paediatric disease designation for Duchenne muscular dystrophy. ...
Posted by Michael Wonder on 15 Jun 2016
Orfadin 20 mg capsules approved in the US
15 June 2016 - Swedish Orphan Biovitrum AB (Sobi) announced today that the FDA has approved a higher strength 20 mg ...
Posted by Michael Wonder on 14 Jun 2016
FDA approves AspireAssist obesity device
14 June 2016 - The U.S. FDA today approved a new obesity treatment device that uses a surgically-placed tube to drain ...
Posted by Michael Wonder on 13 Jun 2016
Accelerated drug approval and health inequality
13 June 2016 - This viewpoint argues that the acceleration of the drug approval process could unequally distribute the costs and ...
Posted by Michael Wonder on 13 Jun 2016
Shire receives FDA breakthrough therapy designation for SHP621 and SHP625, investigational products for rare gastro-intestinal conditions
13 June 2016 - Shire today announced that the U.S. FDA has granted breakthrough therapy designation for two investigational products for ...
Posted by Michael Wonder on 10 Jun 2016
Regulator says too many drug makers chasing same cancer strategy
10 June 2016 - A new type of cancer drug that takes the brakes off the body's immune system has given ...
Posted by Michael Wonder on 10 Jun 2016
FDA approves vaccine to prevent cholera for travelers
10 June 2016 - The U.S. FDA today approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 ...
Posted by Michael Wonder on 08 Jun 2016
Mayne Pharma receives FDA approval for dofetilide capsules and awarded 180 days market exclusivity
7 June 2016 - First generic approval to Pfizer’s US$200m Tikosyn brand. ...
Posted by Michael Wonder on 07 Jun 2016
Sarepta Therapeutics announces FDA request for dystrophin data prior to making a decision on eteplirsen NDA
6 June 2016 - Sarepta Therapeutics today announced that the U.S. FDA has requested that Sarepta provide dystrophin data, as measured ...
Posted by Michael Wonder on 06 Jun 2016
Adamis Pharmaceuticals receives complete response letter from FDA for its epinephrine pre-filled syringe NDA
6 June 2016 - Adamis Pharmaceuticals announced that after the close of the stock markets on 3 June 2016 it received ...
Posted by Michael Wonder on 06 Jun 2016
Allergan announces FDA approval of Byvalson (nebivolol and valsartan)
6 June 2016 - Byvalson is the first and only fixed-dose combination of a beta blocker and angiotensin II receptor ...
Posted by Michael Wonder on 03 Jun 2016
FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
1 June 2016 - The U.S. FDA today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the ...
Posted by Michael Wonder on 02 Jun 2016
Statement from FDA Commissioner Robert Califf on the release of the final individual patient expanded access form
2 June 2016 - Today, the U.S. FDA finalized its efforts to streamline the process used by physicians to request expanded ...
Posted by Michael Wonder on 02 Jun 2016
FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumours
1 June 2016 - The U.S. FDA today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate ...