Blog
RSS FeedPosted by Michael Wonder on 21 Aug 2019
Cassiopea announces FDA submission of new drug application for clascoterone 1% cream, the first new mechanism of action for acne in nearly 40 years
20 August 2019 - Cassiopea announced today that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 20 Aug 2019
Novartis delayed reveal of bad data for $2.1 million gene therapy. Now patients and pharma suffer.
20 August 2019 - Novartis CEO had a rocky start to his tenure. ...
Posted by Michael Wonder on 20 Aug 2019
Teva launches generic version of EpiPen for young children
20 August 2019 - Teva Pharmaceutical Industries on Tuesday made its generic version of Mylan’s EpiPen for young children available in ...
Posted by Michael Wonder on 20 Aug 2019
Ousted Novartis scientist ‘categorically denies’ wrongdoing in data manipulation scandal
20 August 2019 - The scientist, Brian Kaspar, “is a respected member of the scientific community with an impeccable record,” his ...
Posted by Michael Wonder on 20 Aug 2019
Eiger announces FDA breakthrough therapy designation for peginterferon lambda for treatment of hepatitis delta virus infection
20 August 2019 - Fourth Eiger program granted breakthrough therapy designation. ...
Posted by Michael Wonder on 20 Aug 2019
FDA accepts new drug application for VX-445 (elexacaftor), tezacaftor and ivacaftor combination treatment
20 August 2019 - FDA grants priority review of the application and sets a PDUFA target action date of 19 ...
Posted by Michael Wonder on 20 Aug 2019
Moderna receives FDA fast track designation for Zika vaccine mRNA-1893
19 August 2019 - Moderna today announced that the U.S. FDA has granted fast track designation for its investigational Zika vaccine ...
Posted by Michael Wonder on 20 Aug 2019
Sarepta Therapeutics receives complete response letter from the US FDA for golodirsen new drug application
19 August 2019 - Sarepta Therapeutics today announced it had received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 20 Aug 2019
Vanda Pharmaceuticals FDA update for Hetlioz in the treatment of jet lag disorder
19 August 2019 - Vanda Pharmaceuticals today announced that on 16 August 2019, it received a complete response letter from ...
Posted by Michael Wonder on 19 Aug 2019
AbbVie prices new rheumatoid arthritis drug at $59,000 a year
17 August 2019 - AbbVie has priced its new rheumatoid arthritis treatment at $59,000 a year after gaining U.S. approval on ...
Posted by Michael Wonder on 19 Aug 2019
FDA approves new antibiotic to treat community-acquired bacterial pneumonia
19 August 2019 - The U.S. FDA today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. ...
Posted by Michael Wonder on 18 Aug 2019
Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakvi
17 August 2019 - Roche has priced its personalised cancer treatment, Rozlytrek, at about $17,050 per month, nearly half of ...
Posted by Michael Wonder on 18 Aug 2019
Roche drug approval offers a glimpse at the future of cancer treatment
15 August 2019 - The FDA on Thursday approved Roche’s cancer drug Rozlytrek for patients with any kind of tumour ...
Posted by Michael Wonder on 18 Aug 2019
Novartis CEO says FDA process could have been handled better
17 August 2019 - Novartis AG Chief Executive Officer Vas Narasimhan said the company could have handled a furore surrounding ...
Posted by Michael Wonder on 17 Aug 2019
As Sarepta awaits approval of new Duchenne drug, big questions hang over therapy already on market
15 August 2019 - As Sarepta Therapeutics waits for the FDA to announce an approval decision on a new drug ...