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RSS FeedPosted by Michael Wonder on 24 May 2018
FDA accepts supplemental biologics license application and grants priority review for prophylactic and paediatric use for Bio Products Laboratory's Coagadex (coagulation factor X, human) for treatment of hereditary factor X deficiency
23 May 2018 - FDA previously granted Coagadex orphan drug designation for the treatment of hereditary factor X deficiency. ...
Posted by Michael Wonder on 24 May 2018
FDA to review Zynquista (sotagliflozin) as potential treatment for type 1 diabetes
22 May 2018 - The U.S. FDA has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). The investigational oral treatment would be ...
Posted by Michael Wonder on 21 May 2018
Immunomedics submits biologics license application for sacituzumab govitecan to the U.S. Food and Drug Administration
21 May 2018 - First-in-class antibody-drug conjugate had received prior breakthrough therapy designation from the FDA for the treatment of metastatic ...
Posted by Michael Wonder on 21 May 2018
Glenmark Pharmaceuticals announces the company's first new drug application for Ryaltris for patients with seasonal allergic rhinitis
21 May 2018 - Glenmark Pharmaceuticals today announced that the company has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 19 May 2018
FDA accepts new drug application submission for Cosmo Pharmaceuticals' rifamycin SV MMX and sets PDUFA date
18 May 2018 - Cosmo Pharmaceuticals today announced that it has been notified by the U.S. FDA that the agency ...
Posted by Michael Wonder on 17 May 2018
U.S. FDA accepts and acknowledges Coherus BioSciences biologics license application of CHS-1701 (pegfilgrastim biosimilar candidate) for review
14 May 2018 - Coherus BioSciences today announced the U.S. FDA has accepted and acknowledged for review the re-submission of the ...
Posted by Michael Wonder on 17 May 2018
Evolus announces progress with DWP-450 regulatory submissions
16 May 2018 - Evolus receives FDA complete response letter with comments isolated to CMC items. ...
Posted by Michael Wonder on 15 May 2018
Aerie Pharmaceuticals submits new drug application to U.S. FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
15 May 2018 - Submitted as a 505(b)(2) with an expected ten month FDA review. ...
Posted by Michael Wonder on 13 May 2018
Perrigo expects complete response letter on generic version of ProAir
11 May 2018 - Perrigo today announced that it expects to receive a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 10 May 2018
AcelRx resubmits new drug application for Dsuvia
9 May 2018 - AcelRx Pharmaceuticals today announced the resubmission of the new drug application for DSUVIA with the U.S. ...
Posted by Michael Wonder on 07 May 2018
FDA grants priority review to Roche’s cancer immunotherapy Tecentriq (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer
7 May 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 03 May 2018
Coherus Biosciences re-submits biologics license application for CHS-1701 (pegfilgrastim biosimilar candidate)
3 May 2018 - Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the re-submission of its biologics license application (BLA) for CHS-1701, ...
Posted by Michael Wonder on 01 May 2018
Actelion submits supplemental new drug application to US FDA seeking approval of Opsumit (macitentan) for the treatment of chronic thromboembolic pulmonary hypertension
30 April 2018 - Filing supported by data from MERIT-1 trial evaluating Opsumit in adults with inoperable CTEPH which showed significant ...
Posted by Michael Wonder on 01 May 2018
Starpharma completes US new drug application for VivaGel BV
30 April 2018 - VivaGel NDA covers two indications for bacterial vaginosis – treatment and prevention. ...
Posted by Michael Wonder on 26 Apr 2018
Astellas submits new drug applications for approval of gilteritinib for the treatment of FLT3 mutation positive relapsed or refractory acute myeloid leukaemia
24 April 2018 - Astellas Pharma today announced that it submitted on March 23, 2018, a new drug application (NDA) for ...