Enforcement Report - Week of July 10, 2024
10 Jul 2024 //
FDA
Taiho Announces Publication of Final Results of Phase 3 of Decitabine and Cedazuridine
23 Jan 2024 //
PR NEWSWIRE
Taiho Announces Presentation of Data of Oral Decitabine and Cedazuridine
10 Dec 2023 //
PR NEWSWIRE
Otsuka and Astex announce that the European Commission has approved INAQOVI
19 Sep 2023 //
BUSINESSWIRE
Intas Pharmaceuticals Limited on FDA Import Alert List
06 Jun 2023 //
FDA
Foghorn Announces FDA Has Lifted Clinical Hold on Phase 1 Study of FHD-286
06 Jun 2023 //
GLOBENEWSWIRE
Ph 3 Study of DFP-10917 in the R/R AML Patients Shall Be Done
15 May 2023 //
BUSINESSWIRE
EMA accepts application for leukaemia drug from Otsuka and Astex
23 Aug 2022 //
PHARMATIMES
EMA begin Review of Oral Fixed-Dose Combination of Decitabine & Cedazuridine
22 Aug 2022 //
BUSINESSWIRE
Jiangsu Hansoh`s Generic Decitabine Receives Approval in U.S.
15 Apr 2022 //
FDA
EC Grants ODD to Oral Decitabine and Cedazuridine in AML
05 Jan 2022 //
BUSINESSWIRE
Zydus Cadila receives final approval from US FDA for Decitabine injection
19 Nov 2021 //
FDA
Astex Presents OS Data From Phase 3 of INQOVI in MDS and CMML
23 Sep 2021 //
BUSINESSWIRE
Hong Kong`s Generic Decitabine Receives Approval In US
02 Jul 2021 //
FDA
Qilu`s Generic Decitabine Receives Approval In US
16 Apr 2021 //
FDA
Nivagen Pharma`s DecitabineReceives Approval In US
09 Dec 2020 //
FDA
Apotex`s Generic Decitabine Receives Approval in US
26 Nov 2020 //
FDA
National Comprehensive Cancer Network® Adds INQOVI®
23 Nov 2020 //
PRNEWSWIRE
Astex`s Inqovi nod gives patients on decitabine a non-IV option
03 Aug 2020 //
FIERCE PHARMA
Inqovi, an Oral Therapy for Myelodysplastic Syndromes, Gets FDA Approval
13 Jul 2020 //
ONCOLOGYNURSEADIBISOR
Otsuka announcessimultaneous regulatory approvals U.SFDA & Health Canada INQOVI
08 Jul 2020 //
PRESS RELEASE
Bio-Path Holdings Announces Successful Completion of Safety Cohort
05 Apr 2020 //
GLOBENEWSWIRE
Astex`s Announces FDA Acceptance for Review of an NDA Cedazuridine & Decitabine
12 Feb 2020 //
BUSINESSWIRE
MSN labs to launch two new generics in USA
06 Sep 2019 //
THEPHARMALETTER
Novadoz Pharma /MSN Labs Receives FDA Clearance for Fosaprepitant & Decitabine
05 Sep 2019 //
PR NEWSWIRE
Otsuka scores PhIII win for another Astex drug; GSK expands Nucala use in asthma
07 Jun 2019 //
ENDPTS
Wockhardt gets USFDA nod for Decitabine injection
11 Apr 2019 //
MONEYCONTROL
Decitabine Plus Chemo Denotes New Induction Therapy Option for AML
17 Mar 2019 //
ONCNET
Lupin`s Generic Decitabine Receives Approval in US
14 Nov 2018 //
FDA
JIANGSU YEW Pharmaceutical Co. Ltd. Fails EDQM Inspection
15 Sep 2018 //
EDQM
Otsuka’s $886M-plus drug just flopped in its first crucial PhIII trial for AML
01 Aug 2018 //
ENDPTS
Astex Pharms, Otsuka Announce Results of Ph 3 ASTRAL-1 Study of Guadecitabine
31 Jul 2018 //
BUSINESSWIRE
Roche’s Venclexta filed in the US for acute myeloid leukemia
12 Jul 2018 //
PHARMA TIMES
Enforcement Report - Week of April 18, 2018
18 Apr 2018 //
FDA
Cipla’s Generic Decitabine Receives Approval In US
20 Nov 2017 //
FDA
Chemi`s Generic Decitabine Receives Approval In US
28 Sep 2017 //
FDA
Pharmascience`s Generic Decitabine Receives Approval In US
01 Jun 2017 //
FDA
Accord’s Generic Decitabine Receives Approval In US
02 Mar 2017 //
FDA