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  • INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)
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  • SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

https://www.businesswire.com/news/home/20240220135425/en

BUSINESSWIRE
07 Mar 2024

https://www.globenewswire.com//news-release/2023/12/04/2789883/0/en/Polaris-Group-Initiates-Phase-3-Trial-First-Patient-Successfully-Dosed-with-ADI-PEG-20-Placebo-plus-Gemcitabine-and-Docetaxel-for-Difficult-to-Treat-Leiomyosarcoma-LMS.html

GLOBENEWSWIRE
04 Dec 2023

https://www.businesswire.com/news/home/20231109634672/en

BUSINESSWIRE
10 Nov 2023

https://www.businesswire.com/news/home/20231101646990/en

BUSINESSWIRE
01 Nov 2023

https://www.onclive.com/view/intra-arterial-gemcitabine-improves-os-in-locally-advanced-pancreatic-cancer

Chris Ryan ONCLIVE
30 Jun 2023

https://www.businesswire.com/news/home/20230603005002/en

BUSINESSWIRE
03 Jun 2023

https://www.globenewswire.com/news-release/2023/03/07/2621993/37414/en/Panbela-Announces-First-Patient-Enrolled-in-South-Korea-for-ASPIRE-Trial-Studying-Ivospemin-SBP-101-in-Combination-with-Gemcitabine-and-Nab-Paclitaxel-in-Patients-with-Metastatic-P.html

GLOBENEWSWIRE
07 Mar 2023

https://www.globenewswire.com/news-release/2023/01/19/2591871/37414/en/Panbela-Announces-Adoption-of-Commission-Implementing-Decision-from-the-EMA-for-the-Orphan-Designation-of-Ivospemin-SBP-101-in-Combination-with-Gemcitabine-and-Nab-Paclitaxel-in-Pa.html

GLOBENEWSWIRE
19 Jan 2023

https://www.globenewswire.com/news-release/2023/01/17/2589893/0/en/Theriva-Biologics-Announces-First-Patient-Dosed-in-VIRAGE-a-Phase-2b-Trial-of-Systemically-Administered-VCN-01-in-Combination-with-Chemotherapy-in-Pancreatic-Ductal-Adenocarcinoma.html

GLOBENEWSWIRE
18 Jan 2023

https://www.businesswire.com/news/home/20230118005218/en

BUSINESSWIRE
18 Jan 2023

https://www.globenewswire.com//news-release/2023/01/04/2582761/0/en/Tiziana-Life-Sciences-Announces-IND-filed-for-Phase-2-Study-of-Milciclib-in-Combination-with-Gemcitabine-for-Non-Small-Cell-Lung-Cancer.html

GLOBENEWSWIRE
04 Jan 2023

https://www.globenewswire.com/news-release/2022/12/14/2573721/37414/en/Panbela-Receives-Positive-EMA-Opinion-on-Orphan-Designation-for-Ivospemin-SBP-101-in-Combination-with-Gemcitabine-and-Nab-Paclitaxel-in-Patients-with-Metastatic-Pancreatic-Ductal-A.html

GLOBENEWSWIRE
14 Dec 2022

https://www.globenewswire.com/news-release/2022/09/29/2525257/37414/en/Panbela-Receives-Approvals-to-Open-Trial-Sites-in-Spain-France-and-Italy-for-ASPIRE-Trial-Studying-Ivospemin-SBP-101-in-Combination-with-Gemcitabine-and-Nab-Paclitaxel-in-Patients-.html

GLOBENEWSWIRE
30 Sep 2022

https://www.globenewswire.com/news-release/2022/08/11/2496832/37414/en/Panbela-Announces-First-Patient-Enrolled-in-its-Aspire-Trial-Studying-SBP-101-in-Combination-with-Gemcitabine-and-Nab-Paclitaxel-in-Patients-with-Metastatic-Pancreatic-Ductal-Adeno.html

GLOBENEWSWIRE
11 Aug 2022

https://www.fiercepharma.com/drug-delivery/nucanas-twist-chemo-drug-gemzar-fails-phase-3-again

N.P. Taylor FIERCEPHARMA
09 Mar 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-2-2022-1643778781.pdf

FDA
02 Feb 2022

https://endpts.com/microcap-cancer-player-goes-belly-up-after-pancreatic-tumor-hopeful-flops-key-study/

K. Blankenship ENDPTS
27 Jan 2022

https://www.globenewswire.com/news-release/2022/01/26/2373559/37414/en/Panbela-Initiates-a-Randomized-Double-Blind-Placebo-Controlled-Study-ASPIRE-of-Nab-Paclitaxel-and-Gemcitabine-With-or-Without-SBP-101-in-Subjects-Previously-Untreated-for-Metastati.html

GLOBENEWSWIRE
26 Jan 2022

https://www.globenewswire.com/news-release/2022/01/24/2371765/37414/en/Panbela-Presents-Clinical-Data-on-Phase-1b-Clinical-Trial-of-SBP-101-in-Combination-with-Gemcitabine-and-Nab-Paclitaxel-in-Patients-with-Metastatic-PDA-at-2022-ASCO-GI-Meeting.html

GLOBENEWSWIRE
24 Jan 2022

https://www.businesswire.com/news/home/20220119005137/en

BUSINESSWIRE
19 Jan 2022

https://www.globenewswire.com/news-release/2022/01/18/2368484/28235/en/Rafael-Pharmaceuticals-Announces-Ongoing-Successful-Enrollment-and-Opening-of-Additional-Sites-for-Phase-2-Clinical-Trial-of-CPI-613-Devimistat-in-Combination-with-Gemcitabine-and-.html

GLOBENEWSWIRE
18 Jan 2022

https://www.businesswire.com/news/home/20211221005195/en

BUSINESSWIRE
21 Dec 2021

https://www.globenewswire.com/news-release/2021/11/01/2324277/33333/en/Coherus-and-Junshi-Biosciences-Announce-FDA-Acceptance-of-BLA-Filing-for-Toripalimab-for-Treatment-of-Nasopharyngeal-Carcinoma.html

GLOBENEWSWIRE
01 Nov 2021

https://www.marketwatch.com/story/erytech-pharma-shares-fall-after-disappointing-pancreatic-cancer-trial-271635158039

M. Grossman MARKETWATCH
26 Oct 2021

https://endpts.com/some-cancer-patients-now-have-to-find-other-options-as-bristol-myers-abraxane-falls-into-shortage-from-manufacturing-woes/

Zachary Brennan ENDPTS
20 Oct 2021

https://www.globenewswire.com/news-release/2021/08/25/2286471/28235/en/Rafael-Pharmaceuticals-Announces-the-Successful-Completion-of-Phase-1b-Clinical-Trial-and-Initiates-Phase-2-for-CPI-613-devimistat-in-Combination-with-Gemcitabine-and-Cisplatin-in-.html

GLOBENEWSWIRE
25 Aug 2021

http://www.pharmabiz.com/NewsDetails.aspx?aid=142064&sid=2

PHARMABIZ
25 Aug 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206617

FDA
25 Jun 2021

https://www.prnewswire.com/news-releases/patent-expiry-of-branded-oncology-products-in-gemcitabine-hcl-market-turn-into-copious-revenues-for-generic-players-collaborations-to-enrich-value-chain-tmr-301318371.html

PRNEWSWIRE
23 Jun 2021

https://www.globenewswire.com/news-release/2021/06/16/2248146/33525/en/Pamrevlumab-Included-in-Pancreatic-Cancer-Action-Network-s-Adaptive-Clinical-Trial-Platform.html

GLOBENEWSWIRE
16 Jun 2021

https://www.ab-science.com/results-from-masitinib-study-ab12005-in-pancreatic-cancer-have-been-presented-at-the-2021-asco-annual-meeting/

PRESS RELEASE
10 Jun 2021

http://www.pharmabiz.com/NewsDetails.aspx?aid=137785&sid=2

PHARMABIZ
14 Apr 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212129

FDA
15 Dec 2020

https://www.prnewswire.com/news-releases/innovent-and-lilly-jointly-release-phase-3-results-of-tyvyt-sintilimab-injection-in-combination-with-gemzar-gemcitabine-and-platinum-chemotherapy-as-first-line-treatment-for-squamous-non-small-cell-lung-cancer-at-esmo-virtua-301134399.html

PRNEWSWIRE
20 Sep 2020

https://www.prnewswire.com/news-releases/renovorx-announces-orphan-drug-designation-granted-for-treating-bile-duct-cancer-301068993.html

PRNEWSWIRE
03 Jun 2020

https://www.prnewswire.com/news-releases/tyvyt-sintilimab-injection-combined-with-gemzar-gemcitabine-for-injection-and-platinum-chemotherapy-met-the-predefined-primary-endpoint-in-the-phase-3-orient-12-study-as-first-line-therapy-in-patients-with-locally-advanced-o-301054428.html

PRNEWSWIRE
06 May 2020

https://www.prnewswire.com/news-releases/ascentage-pharma-announces-approval-for-the-phase-ibii-clinical-trial-of-apg-1387-in-combination-with-chemotherapy-for-the-treatment-of-advanced-pancreatic-cancer-in-china-301009833.html

PR NEWSWIRE
24 Feb 2020

https://www.businesswire.com/news/home/20200127005215/en

BUSINESSWIRE
27 Jan 2020

https://www.prnewswire.com/news-releases/armas-pharmaceuticals-adds-four-generic-injectables-as-first-launches-of-2020-300989083.html

PR NEWS WIRE
20 Jan 2020

https://www.globenewswire.com/news-release/2020/01/06/1966381/0/en/BridgeBio-Pharma-s-QED-Therapeutics-Receives-Fast-Track-Designation-for-Infigratinib-in-Adults-with-First-Line-Advanced-or-Metastatic-Cholangiocarcinoma-and-Orphan-Drug-Designation.html

GLOBE NEWSWIRE
06 Jan 2020

https://www.fiercebiotech.com/biotech/lilly-s-armo-buyout-drug-a-bust-pancreatic-cancer

Ben Adams FIERCE BIOTECH
17 Oct 2019

https://www.biospace.com/article/lilly-s-pancreatic-drug-flunks-phase-iii-trial/?s=95

Mark Terry BIOSPACE
17 Oct 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210991

FDA
09 Oct 2019

https://endpts.com/roches-tecentriq-excels-in-another-lung-cancer-study/

Natalie Grover ENDPOINTSNEWS
13 Sep 2019

https://www.fiercebiotech.com/biotech/nucana-s-retooled-chemo-drug-comes-up-short-pancreatic-cancer-phase-3

A. Al Idrus FIERCE BIOTECH
22 Aug 2019

https://www.fiercebiotech.com/biotech/another-effort-pancreatic-cancer-flops-as-boston-biomedical-cans-phase-3-combo-test

Ben Adams FIERCE BIOTECH
02 Jul 2019

https://www.biospectrumasia.com/news/49/13203/sun-pharma-launches-infugem-in-the-u-s-.html

BIOSPECTRUMASIA
08 Apr 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210383

FDA
14 Feb 2019

https://www.ema.europa.eu/documents/psusa/gemcitabine-list-nationally-authorised-medicinal-products-psusa/00001519/201801_en.pdf

EMA
12 Nov 2018

https://endpts.com/sun-biopharma-founder-michael-cullen-steps-up-semathera-settles-on-permanent-ceo-oncosec-nabs-kellie-malloy-foerter-from-syneos/

Amber Tong ENDPTS
02 Nov 2018
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