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RSS FeedPosted by Michael Wonder on 11 Feb 2018
Salix provides update on FDA submission for Plenvu
9 February 2018 - Salix Pharmaceuticals and its partner Norgine have received notice that the U.S. FDA has extended the PDUFA ...
Posted by Michael Wonder on 08 Feb 2018
Verastem submits new drug application to U.S. FDA for duvelisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia leukaemia/small lymphocytic lymphoma and follicular lymphoma
7 February 2018 - Verastem today announced it has submitted a new drug application to the U.S. FDA seeking full approval ...
Posted by Michael Wonder on 07 Feb 2018
SIGA Technologies announces FDA accepts NDA and grants priority review for oral Tpoxx to treat smallpox
7 February 2018 - If approved, Tpoxx would be the first treatment for smallpox. ...
Posted by Michael Wonder on 06 Feb 2018
Paratek completes submission of new drug applications to U.S. FDA for oral and intravenous omadacycline for pneumonia and skin infections
5 February 2018 - Paratek Pharmaceuticals announced today that on February 2, 2018, it completed the submission of two new drug ...
Posted by Michael Wonder on 04 Feb 2018
Alnylam announces FDA acceptance of new drug application and priority review status for patisiran, an investigational RNAi therapeutic for the treatment of hereditary ATTR amyloidosis
1 February 2018 - PDUFA date set for 11 August 2018. ...
Posted by Michael Wonder on 31 Jan 2018
Alkermes submits new drug application to U.S. FDA for ALKS 5461 for the adjunctive treatment of major depressive disorder
31 January 2018 - New medicine for treating major depressive disorder supported by comprehensive efficacy and safety data package from ...
Posted by Michael Wonder on 30 Jan 2018
Theravance Biopharma and Mylan announce FDA acceptance of new drug application for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease
29 January 2018 - FDA assigns PDUFA target action date of 13 November 2018. ...
Posted by Michael Wonder on 30 Jan 2018
Aradigm receives complete response letter from the FDA for Linhaliq NDA
29 January 2018 - Aradigm today announces that it received a complete response letter from the US FDA regarding its new ...
Posted by Michael Wonder on 22 Jan 2018
Braeburn receives complete response letter for CAM2038 injectable buprenorphine depot for the treatment of opioid use disorder
21 January 2018 - Braeburn Pharmaceuticals today announced that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 20 Jan 2018
U.S. FDA grants priority review for daratumumab in front line multiple myeloma
19 January 2018 - 21 May 2018 PDUFA date. ...
Posted by Michael Wonder on 19 Jan 2018
Aquestive Therapeutics announces U.S. FDA filing acceptance of new drug application for clobazam oral soluble film to treat Lennox-Gastaut syndrome
18 January 2018 - Aquestive Therapeutics today announced that the U.S. FDA has accepted for review the company’s new drug application ...
Posted by Michael Wonder on 17 Jan 2018
Novartis granted US FDA priority review for Kymriah (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL
17 January 2018 - Filing acceptance marks second priority review granted to Kymriah by the FDA for two distinct indications, underscoring ...
Posted by Michael Wonder on 16 Jan 2018
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
16 January 2018 - The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab matches the reference ...
Posted by Michael Wonder on 11 Jan 2018
New guidance: When can the FDA refuse to file NDAs and BLAs?
10 January 2018 - According to US FDA regulations, the regulatory agency may refuse to file a new drug application ...
Posted by Michael Wonder on 09 Jan 2018
pSivida submits new drug application for Durasert three year treatment for posterior segment uveitis to the U.S. FDA
8 January 2018 - Proven Durasert technology has to date received FDA approval for three of the four sustained release drug ...