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RSS FeedPosted by Michael Wonder on 09 Nov 2019
Cassiopea announces FDA acceptance of its new drug application for clascoterone 1% cream, the first new mechanism of action for acne in nearly 40 years
8 November 2019 - Cassiopea announced today the U.S. FDA has accepted for review the new drug application for clascoterone cream ...
Posted by Michael Wonder on 09 Nov 2019
Janssen announces submission of supplemental new drug application to U.S. FDA seeking approval of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia
8 November 2019 - Supplemental new drug application -- submitted through FDA real-time oncology review program -- is based on positive ...
Posted by Michael Wonder on 31 Oct 2019
FDA grants appeal to Recro Pharma for IV meloxicam new drug application
31 October 2019 - Received positive response from FDA regarding IV meloxicam formal dispute resolution request. ...
Posted by Michael Wonder on 30 Oct 2019
EMA and FDA accept marketing applications for Chugai's satralizumab in neuromyelitis optica spectrum disorder
30 October 2019 - The applications will be reviewed under accelerated assessment by EMA. ...
Posted by Michael Wonder on 29 Oct 2019
Omeros Corporation initiates BLA submission for narsoplimab for the treatment of HSCT-TMA
28 October 2019 - Rolling submission of the remaining BLA sections continues on track for scheduled completion 1H 2020. ...
Posted by Michael Wonder on 29 Oct 2019
Blueprint Medicines announces FDA intent to split avapritinib new drug application into separate submissions for PDGFRA exon 18 mutant GIST and fourth-line GIST
28 October 2019 - Given proximity of NDA action date to anticipated top-line data readout for Phase 3 VOYAGER trial, FDA ...
Posted by Michael Wonder on 28 Oct 2019
Heron Therapeutics announces FDA acceptance of new drug application resubmission for HTX-011 for management of post-operative pain
28 October 2019 - FDA sets prescription drug user fee act goal date of 26 March 2020. ...
Posted by Michael Wonder on 27 Oct 2019
Spectrum Pharmaceuticals announces submission to the U.S. FDA of updated biologics license application for Rolontis
24 October 2019 - Rolontis filing is based on two large pivotal randomised controlled studies that met all primary and secondary ...
Posted by Michael Wonder on 22 Oct 2019
Biogen plans regulatory filing for aducanumab in Alzheimer’s disease based on new analysis of larger dataset from Phase 3 studies
22 October 2019 - New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease ...
Posted by Michael Wonder on 21 Oct 2019
Bayer submits supplemental new drug application to FDA for intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg
21 October 2019 - Application seeks to extend duration of use up to six years for Mirena. ...
Posted by Michael Wonder on 17 Oct 2019
Foamix announces FDA acceptance of its new drug application for FMX103 minocycline foam for the treatment of moderate-to-severe papulopustular rosacea
17 October 2019 - PDUFA target action date of 2 June 2020 ...
Posted by Michael Wonder on 16 Oct 2019
ViiV Healthcare submits supplemental new drug application to US FDA for use of Dovato in virologically suppressed adults with HIV-1
16 October 2019 - ViiV Healthcare announced the submission of a supplemental New Drug Application to the US FDA for ...
Posted by Michael Wonder on 14 Oct 2019
Flexion Therapeutics announces extended FDA review of supplemental new drug application for Zilretta
14 October 2019 - Flexion Therapeutics today announced that the U.S. FDA has informed the company it needs additional time ...
Posted by Michael Wonder on 08 Oct 2019
FDA accepts resubmitted new drug application for ITCA 650
8 October 2019 - Intarcia Therapeutics announced today that the U.S. FDA has accepted the company's resubmission of its new ...
Posted by Michael Wonder on 07 Oct 2019
Janssen submits application to U.S. FDA seeking approval of Stelera (ustekinumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis
7 October 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental biologics license ...