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https://www.prnewswire.com/news-releases/johnson--johnson-submits-supplemental-biologics-license-application-to-us-fda-seeking-approval-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-based-regimen-for-the-treatment-of-patients-with-transplant-eligible-newly-302048440.html

PR NEWSWIRE
30 Jan 2024

https://www.businesswire.com/news/home/20240126251451/en

BUSINESSWIRE
27 Jan 2024

https://ir.halozyme.com/news/news-details/2024/Halozyme-Announces-Takeda-Receives-FDA-Approval-for-HYQVIA-Co-formulated-with-ENHANZE-as-Maintenance-Therapy-in-Adults-with-Chronic-Inflammatory-Demyelinating-Polyneuropathy-CIDP/default.aspx

PRESS RELEASE
17 Jan 2024

https://www.prnewswire.com/news-releases/darzalex-faspro-daratumumab-and-hyaluronidase-fihj-based-quadruplet-therapy-regimen-shows-significant-improvement-in-outcomes-for-patients-with-transplant-eligible-newly-diagnosed-multiple-myeloma-302012983.html

PR NEWSWIRE
12 Dec 2023

https://www.prnewswire.com/news-releases/alteogens-tergase-novel-recombinant-human-hyaluronidase-injection-shows-excellent-immunogenicity-profile-301916724.html

PR NEWSWIRE
05 Sep 2023

https://www.pharmacompass.com/pdf/news/bioindustria-laboratorio-italiano-medicinali-spa-fails-edqm-inspection-48057.pdf

EDQM
08 Oct 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145

FDA
21 Jan 2022

https://www.prnewswire.com/news-releases/halozyme-announces-janssen-receives-us-fda-approval-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-in-combination-with-carfilzomib-and-dexamethasone-for-patients-with-multiple-myeloma-after-first-or-subsequent-relapse-301435510.html

PRNEWSWIRE
01 Dec 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145

FDA
30 Nov 2021

https://www.prnewswire.com/news-releases/halozyme-announces-janssen-receives-us-fda-approval-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-in-combination-with-pomalidomide-and-dexamethasone-for-patients-with-multiple-myeloma-after-first-or-subsequent-relapse-301331450.html

PRNEWSWIRE
12 Jul 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761064

FDA
15 Jun 2021

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

PHARMABIZ
12 Sep 2020

https://seekingalpha.com/news/3612850-j-and-j-files-u-s-application-for-expanded-use-of-darzalex-faspro

SEEKINGALPHA
09 Sep 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145

FDA
06 May 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761064

FDA
06 May 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761064

FDA
20 Dec 2019

https://www.businesswire.com/news/home/20191202005348/en

BUSINESS WIRE
02 Dec 2019

https://www.raps.org/news-and-articles/news-articles/2019/9/fda-compiles-list-of-ndas-transitioning-to-blas-ne

Z.Brennan RAPS
24 Sep 2019

https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-August-15-2018-1534336681.pdf

FDA
15 Aug 2018

http://www.biospectrumasia.com/news/25/9100/rituxan-hycela-approved-by-fda-for-subcutaneous-injection-in-certain-blood-cancers.html

BIOSPECTRUM
23 Jun 2017

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761064

FDA
22 Jun 2017

http://www.pharmatimes.com/news/shire_launches_immunodeficiency_drug_for_children_1078376

Selina McKee PHARMATIMES
22 Jul 2016
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