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  • INJECTABLE;INJECTION - 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE;ORAL - 25MG
  • CAPSULE;ORAL - 50MG

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-10-2024-2074.pdf

FDA
10 Apr 2024

https://www.businesswire.com/news/home/20240228816982/en

BUSINESSWIRE
28 Feb 2024

https://www.globenewswire.com//news-release/2024/01/18/2811519/37414/en/Panbela-Announces-Publication-of-Clinical-Data-Titled-Phase-1-study-of-high-dose-DFMO-celecoxib-cyclophosphamide-and-topotecan-for-patients-with-relapsed-neuroblastoma-A-New-Approa.html

GLOBENEWSWIRE
18 Jan 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216958

FDA
18 Dec 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211552

FDA
13 Dec 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214529

FDA
17 Jul 2023

https://www.onclive.com/view/ibrutinib-plus-chemoimmunotherapy-fails-to-improve-pfs-in-pretreated-follicular-lymphoma-mzl

Caroline Seymour ONCLIVE
20 Jun 2023

https://endpts.com/fda-adcomm-votes-11-2-to-expand-roches-polivy-label-in-dlbcl/

Paul Schloesser ENDPTS
10 Mar 2023

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-cyclophosphamide-injection-81558.pdf

FDA
23 Feb 2023

https://www.europeanpharmaceuticalreview.com/news/177879/stem-cell-transplants-may-slow-disability-progression-in-ms/

Caroline Peachey EUROPEANPHARMACEUTICALREVIEW
22 Dec 2022

https://www.businesswire.com/news/home/20221212005169/en

BUSINESSWIRE
11 Dec 2022

https://health.economictimes.indiatimes.com/news/pharma/alembic-pharmaceuticals-gets-final-usfda-approval-for-cyclophosphamide-capsules/95503807

HEALTH ET
14 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215892

FDA
10 Nov 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211757

FDA
18 Oct 2022

https://www.labiotech.eu/trends-news/genentech-lymphoma-treatment/

Jim Cornall LABIOTECH
16 Aug 2022

https://www.businesswire.com/news/home/20220811005193/en

BUSINESSWIRE
11 Aug 2022

https://www.pharmatimes.com/news/smc_approve_johnson_and_johnsons_systemic_light_chain_amyloidosis_therapy_1453205

John Pinching PHARMA TIMES
10 Aug 2022

http://www.pharmafile.com/news/721160/smc-accepts-first-licensed-treatment-newly-diagnosed-al-amyloidosis

PHARMAFILE
09 Aug 2022

https://www.expresspharma.in/european-commission-approves-roches-polivy-combination-for-people-with-previously-untreated-diffuse-large-b-cell-lymphoma/

EXPRESS PHARMA
26 May 2022

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-cyclophosphamide-1650689407.pdf

FDA
21 Apr 2022

https://www.businesswire.com/news/home/20220119005536/en

BUSINESSWIRE
19 Jan 2022

https://www.cancernetwork.com/view/progression-free-survival-boost-noted-with-polatuzumab-vedotin-plus-r-chp-for-previously-untreated-dlbcl

CANCERNETWORK
17 Dec 2021

https://www.globenewswire.com/news-release/2021/11/12/2333443/19219/en/Positive-Recommendation-for-Use-of-TAVNEOS-avacopan-in-ANCA-Vasculitis-Adopted-by-European-Medicines-Agency-EMA-Committee-for-Medicinal-Products-for-Human-Use-CHMP.html

GLOBENEWSWIRE
12 Nov 2021

https://www.biospace.com/article/crispr-therapeutics-announces-promising-data-for-its-car-t-cancer-therapy/?s=71

Mark Terry BIOSPACE
13 Oct 2021

https://www.onclive.com/view/lurbinectedin-doxorubicin-misses-os-end-point-in-relapsed-sclc-but-shows-superior-safety-vs-soc

ONCLIVE
10 Sep 2021

http://www.pharmabiz.com/NewsDetails.aspx?aid=142169&sid=2

PHARMABIZ
28 Aug 2021

https://www.prnewswire.com/news-releases/cbmg-holdings-novel-anti-cd20-car-t-cell-therapy-shows-promising-safety-and-efficacy-in-relapsedrefractory-b-cell-non-hodgkin-lymphoma-patients-following-relapse-to-an-anti-cd19-car-t-therapy-301310049.html

PRNEWSWIRE
10 Jun 2021

https://www.prnewswire.com/news-releases/cbmg-holdings-novel-cd19cd20-bi-specific-car-t-cell-product-shows-early-promising-clinical-efficacy-and-favorable-safety-profile-in-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-301310047.html

PRNEWSWIRE
10 Jun 2021

https://www.renalandurologynews.com/home/conference-highlights/era-edta-congress/belimumab-plus-standard-lupus-nephritis-therapy-improves-renal-responses/

RENAL & NEURO NEWS
09 Jun 2021

https://www.globenewswire.com/news-release/2021/06/07/2242640/0/en/Salarius-Pharmaceuticals-Presents-New-Research-Data-Demonstrating-Seclidemstat-s-Safety-Dosing-and-Drug-Activity-at-American-Society-of-Clinical-Oncology-ASCO-2021-Annual-Meeting.html

GLOBENEWSWIRE
07 Jun 2021

https://www.esmo.org/meetings/esmo-virtual-congress-2020/daily-reporter/daily-reporter-news/increased-clarity-on-role-immunotherapy-early-tnbc

ESMO
20 Sep 2020

http://www.pharmabiz.com/NewsDetails.aspx?aid=131047&sid=2

PHARMABIZ
12 Sep 2020

https://www.prnewswire.com/news-releases/eha25virtual-study-of-subcutaneous-daratumumab-shows-improved-clinical-outcomes-in-the-treatment-of-patients-with-amyloidosis-301075077.html

PRNEWSWIRE
12 Jun 2020

http://www.pharmabiz.com/NewsDetails.aspx?aid=126826&sid=2

PHARMABIZ
12 Jun 2020

https://www.businesswire.com/news/home/20200514005207/en

BUSINESSWIRE
14 May 2020

http://www.pharmabiz.com/NewsDetails.aspx?aid=122169&sid=2

PHARMABIZ
01 Apr 2020

https://www.takeda.com/newsroom/newsreleases/2020/takeda-receives-positive-chmp-opinion-for-adcetris-brentuximab-vedotin-in-combination-with-chp-cyclophosphamide-doxorubicin-and-prednisone/

PRESS RELEASE
31 Mar 2020

https://seekingalpha.com/news/3508477-hexo-closes-c-70m-convertible-debt-deal

Douglas W. House SEEKINGALPHA
23 Oct 2019

https://www.kiadis.com/investors/regulatory-news/single-regulatory-news/?1931464

PRESS RELEASE
18 Oct 2019

https://www.fiercepharma.com/pharma/seattle-genetics-investors-breathe-a-sigh-relief-as-adcetris-scores-30-sales-growth

Arlene Weintraub FIERCE PHARMA
17 Jul 2019

https://www.biospace.com/article/unum-plunges-after-fda-places-another-clinical-hold-on-company-asset/

BIOSPACE
04 Jul 2019

https://www.fiercepharma.com/pharma-asia/foreign-drugmakers-under-threat-as-china-rolls-out-drug-list-to-boost-generic

Angus Liu FIERCE PHARMA
21 Jun 2019

https://endpts.com/takeda-suffers-another-setback-in-its-quest-to-expand-myeloma-drugs-reach-and-blockbuster-potential/

John Carroll ENDPTS
06 Jun 2019

https://www.reuters.com/article/us-novartis-rituximab/novartis-abandons-effort-for-u-s-approval-of-biosimilar-rituximab-idUSKCN1N72NA

Diptendu Lahiri REUTERS
03 Nov 2018

https://www.businesswire.com/news/home/20181101006091/en

BUSINESSWIRE
01 Nov 2018

https://www.businesswire.com/news/home/20181010005787/en/Celltrion-Teva-Announce-FDA-Oncologic-Drugs-Advisory

BUSINESSWIRE
11 Oct 2018

https://www.raps.org/news-and-articles/news-articles/2018/8/fda-recommends-use-of-placebo-only-in-certain-onco?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2023%20August

Zachary Brennan RAPS
24 Aug 2018

https://endpts.com/need-a-placebo-control-group-for-your-next-cancer-drug-study-only-in-certain-circumstances-says-fda/

Zachary Brennan - RAPS ENDPTS
23 Aug 2018

https://www.genengnews.com/gen-news-highlights/epizyme-halts-phase-ii-trial-of-tazemetostat-in-dlbcl-continues-talks-to-lift-clinical-hold/81256092

GEN
02 Aug 2018

https://pharmaphorum.com/cancer/accords-biosimilar-pelgraz-poised-for-approval/

Joy Persaud PHARMAPHORUM
31 Jul 2018
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