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RSS FeedPosted by Michael Wonder on 25 Oct 2018
FDA declines to approve pre-filled syringe version of Regeneron's Eylea
25 October 2018 - Regeneron Pharmaceuticals said on Thursday the U.S. FDA declined to approve a pre-filled syringe version of ...
Posted by Michael Wonder on 25 Oct 2018
Duchesnay announces submission of supplemental new drug application for Osphena (ospemifene) to U.S. FDA seeking approval for the treatment of vaginal dryness, a symptom of vulvar and vaginal atrophy due to menopause
23 October 2018 - Duchesnay announced today that it has submitted a supplemental new drug application to the U.S. FDA ...
Posted by Michael Wonder on 23 Oct 2018
DBV Technologies announces submission of biologics license application for Viaskin Peanut to the U.S. FDA
22 October 2018 - DBV Technologies today announced the submission of a biologics license application to the U.S. FDA for Viaskin ...
Posted by Michael Wonder on 20 Oct 2018
Bristol-Myers Squibb provides update on the ongoing regulatory review of Opdivo plus low dose Yervoy in first-line lung cancer patients with tumour mutational burden ≥10 mut/Mb
19 October 2018 - New analysis submitted to U.S. FDA constitutes a major amendment to the Company’s supplemental biologics license application. ...
Posted by Michael Wonder on 19 Oct 2018
ViiV Healthcare submits new drug application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
18 October 2018 - Priority review voucher used with submission with anticipated target action date of six months. ...
Posted by Michael Wonder on 17 Oct 2018
AbbVie announces supplemental new drug application accepted for priority review by U.S. FDA for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) for previously untreated chronic lymphocytic leukaemia
17 October 2018 - The submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial, which showed longer ...
Posted by Michael Wonder on 09 Oct 2018
Recro Pharma announces PDUFA date for IV meloxicam
8 October 2018 - PDUFA Date Set for 24 March 2019. ...
Posted by Michael Wonder on 08 Oct 2018
Novartis announces FDA and EMA filing acceptance of siponimod, the first and only drug shown to meaningfully delay disability progression in typical SPMS patients
8 October 2018 - If approved, siponimod (BAF312) would be the first oral disease-modifying therapy with the potential to delay progression ...
Posted by Michael Wonder on 06 Oct 2018
U.S. FDA accepts Karyopharm’s new drug application for selinexor and grants priority review
5 October 2018 - Application seeks accelerated approval for selinexor as a treatment for patients with penta-refractory multiple myeloma. ...
Posted by Michael Wonder on 03 Oct 2018
Paratek announces FDA approval of Nuzyra (omadacycline)
2 October 2018 - First and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSI patients in ...
Posted by Michael Wonder on 03 Oct 2018
ADMA Biologics resubmits biologics license application for RI-002
1 October 2018 - ADMA Biologics announces that the Company has responded to the July 2016 complete response letter and ...
Posted by Michael Wonder on 01 Oct 2018
Shield Therapeutics announces submission of a new drug application for Feraccru with the US FDA
1 October 2018 - Shield Therapeutics today announces that it has received confirmation from the US FDA of its successful ...
Posted by Michael Wonder on 01 Oct 2018
Intra-Cellular Therapies completes submission of new drug application for lumateperone for treatment of schizophrenia
28 September 2018 - Intra-Cellular Therapies today announced that the company has completed the rolling submission of its new drug application ...
Posted by Michael Wonder on 27 Sep 2018
Samsung Bioepis’ biologics license application for SB5 adalimumab biosimilar candidate accepted for review by the U.S. FDA
27 September 2018 - The biologics license application for SB5 was based on a 52 week Phase 3 study comparing SB5 ...
Posted by Michael Wonder on 27 Sep 2018
Allergan announces FDA acceptance of supplemental new drug application for Vraylar (cariprazine)
26 September 2018 - Application seeks to expand Vraylar indication to include the treatment of bipolar depression. ...