Blog
RSS FeedPosted by Michael Wonder on 06 Apr 2018
Antares Pharma provides Xyosted regulatory update
5 April 2018 - Complete response resubmission accepted – PDUFA date 29 September 2018. ...
Posted by Michael Wonder on 06 Apr 2018
Stemline Therapeutics announces start of rolling BLA submission for SL-401
5 April 2018 - Stemline Therapeutics announced today that it has initiated its rolling submission of a biologics license application for ...
Posted by Michael Wonder on 04 Apr 2018
Paratek’s new drug applications for oral and intravenous omadacycline accepted for priority review by FDA
4 April 2018 - PDUFA action date in October 2018. ...
Posted by Michael Wonder on 04 Apr 2018
Proteostasis Therapeutics receives FDA fast track designation for triple combination program in patients with cystic fibrosis
4 April 2018 - Proteostasis Therapeutics today announced that the U.S. FDA has granted fast track designation for the company's triple ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA and European Medicines Agency accept regulatory submissions for review of dacomitinib to treat metastatic non-small-cell lung cancer with EGFR-activating mutations
4 April 2018 - FDA priority review granted for U.S. new drug application. ...
Posted by Michael Wonder on 04 Apr 2018
US FDA approves Bydureon for use with basal insulin in patients with type 2 diabetes with inadequate glycemic control
3 April 2018 - Duration-7 study results showed significant HbA1c reduction when Bydureon was added to insulin glargine therapy vs insulin ...
Posted by Michael Wonder on 04 Apr 2018
Motif Bio initiates NDA rolling submission for iclaprim
3 April 2018 - Motif Bio today announced the initiation of a rolling submission of a new drug application to ...
Posted by Michael Wonder on 04 Apr 2018
U.S. FDA grants fast track designation to Taris for TAR-200 (GemRIS) in muscle invasive bladder cancer
3 April 2018 - Designation for patients unfit for curative intent therapy. ...
Posted by Michael Wonder on 03 Apr 2018
US FDA accepts biologics license application for moxetumomab pasudotox in hairy cell leukaemia
3 April 2018 - Moxetumomab pasudotox application granted priority review. ...
Posted by Michael Wonder on 03 Apr 2018
FDA charts path forward for biosimilars — but drug makers aren’t all on board
30 March 2018 - In his recent public appearances, FDA Commissioner Scott Gottlieb has sounded a repeating note: drug prices ...
Posted by Michael Wonder on 03 Apr 2018
Eisai submits supplemental new drug application to FDA for Fycompa (perampanel) paediatric indications
31 March 2018 - First step to making Fycompa available for children, underscoring Eisai's commitment to epilepsy care for patients of ...
Posted by Michael Wonder on 03 Apr 2018
Alkermes receives refusal to file letter from FDA for ALKS 5461
2 April 2018 - Alkermes today announced that it received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 30 Mar 2018
Sunovion submits new drug application to the FDA for apomorphine sublingual film (APL-130277) for the treatment of off episodes associated with Parkinson's disease
30 March 2018 - Submission is supported by Phase 3 clinical study data showing that the investigational medicine demonstrated superior efficacy ...
Posted by Michael Wonder on 30 Mar 2018
Statement from FDA Commissioner on FDA’s efforts to enhance the patient perspective and experience in drug development and review
30 March 2018 - Benefit-risk assessment is at the heart of what we do to ensure that Americans have access ...
Posted by Michael Wonder on 30 Mar 2018
Insmed submits new drug application to FDA for ALIS in NTM lung disease caused by MAC
29 March 2018 - ALIS previously designated as an orphan drug, breakthrough therapy and qualified infectious disease product. ...