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RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Aug 2019
FDA approves treatment for patients with rare bone marrow disorder
16 August 2019 - Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with ...
Posted by Michael Wonder on 16 Aug 2019
AbbVie receives FDA approval of Rinvoq (upadacitinib), an oral JAK inhibitor for the treatment of moderate to severe rheumatoid arthritis
16 August 2019 - Approval supported by efficacy and safety data from one of the largest registrational Phase 3 programs in ...
Posted by Michael Wonder on 15 Aug 2019
Growing numbers of priority and competitive ANDAs under review as approvals trickle in
15 August 2019 - The US FDA on Wednesday released quarterly data on two of its programs aimed at increasing generic ...
Posted by Michael Wonder on 15 Aug 2019
FDA approves Genentech’s Rozlytrek (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours
15 August 2019 - First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer ...
Posted by Michael Wonder on 15 Aug 2019
The lengths Americans go to for cheap medicine
15 August 2019 - With drug prices soaring in the US, people are travelling to Canada to buy life-saving medication. ...
Posted by Michael Wonder on 15 Aug 2019
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumour
15 August 2019 - FDA also approves drug for second indication in a type of lung cancer. ...