Late Stage Development. June 23, 2021. Select programs in the pivotal phase and in registration/approval for the US/EU (removed after programs achieve approval in both US/EU).
04.11.2021 · In addition to U.S. Breakthrough Therapy Designation (BTD) granted in December 2019, by the U.S. FDA, Janssen also received Orphan Drug Designation for cilta-cel, in February 2019. In December 2020, Janssen announced initiation of a rolling submission of its BLA to the U.S. FDA for cilta-cel, which was accepted under Priority Review in May 2021.
Explore Janssen's innovative medical research & pharmaceutical product development practices to see how Janssen is creating a future where disease is a ...
Select New Molecular Entity programs recently approved or with potential filings in the US/EU within a specified window as outlined in the Pharmaceutical ...
Sep 14, 2020 · The Janssen Pharmaceutical Companies of Johnson & Johnson today announced multiple data presentations from its oncology portfolio and pipeline, in ... 2020. 15 Johnson & Johnson. Janssen Announces ...
Janssen Pharmaceutical Companies of Johnson & Johnson Selected NME Pharmaceutical Pipeline - Recent Approvals/Potential Filings* Selective Highlights as of October 13, 2020
UPTRAVI (selexipag) Pediatric pulmonary arterial hypertension. Phase III US. Phase III EU. This information is accurate as of the date hereof to the best of the Company's knowledge. Johnson & Johnson assumes no obligation to update this information. (2) aprocitentan developed in collaboration with Idorsia; (3) XARELTO co-developed with Bayer ...
Mechanism: PD-1/CTLA-4 bispecific mAb + VEGF; Area under investigation:advanced renal cell carcinoma; Date commenced phase: Q3 2020; Estimated Filing ...
Janssen Pharmaceutical Companies of Johnson & Johnson Selected NME Pharmaceutical Pipeline - Recent Approvals/Potential Filings* Selective Highlights as of October 13, 2020. NME PLANNED FILINGS 2020-2023*
May 29, 2020 · RARITAN, N.J., May 29, 2020 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the latest research from its innovative oncology portfolio and pipeline of ...
Janssen Pharmaceutical Companies of Johnson & Johnson Selected NME Pharmaceutical Pipeline - Recent Approvals/Potential Filings* Selective Highlights as of April 14, 2020 NME PLANNED FILINGS 2020-2023* ERLEADA® (apalutamide) (EU) Non-metastatic prostate cancer Adjunctive treatment for major depressive disorder with insomnia symptoms
Nov 04, 2021 · In December 2020, Janssen announced initiation of a rolling submission of its BLA to the U.S. FDA for cilta-cel, which was accepted under Priority Review in May 2021. In November 2021, Janssen announced the extension of the PDUFA date.
Johnson & Johnson has an expansive archive of existing drug compounds—and two researchers are leading the charge in combing through this molecular storehouse in pursuit of a possible breakthrough. It's the sixth leading cause of death in the United States, with no existing cure.
Janssen Pharmaceutical Companies of Johnson & Johnson Selected NME Pharmaceutical Pipeline - Recent Approvals/Potential Filings* (2019-2023 Key Filings, As Outlined at 2019 Pharm Business Review) Selective Highlights as of January 26, 2021 *Filings/approvals assumed to be in the US and EU unless otherwise noted.
Late Stage Development. June 23, 2021. Select programs in the pivotal phase and in registration/approval for the US/EU (removed after programs achieve approval in both US/EU).
Janssen Pharmaceutical Companies of Johnson & Johnson Selected NME Pharmaceutical Pipeline - Recent Approvals/Potential Filings* (2019-2023 Key Filings, As Outlined at 2019 Pharm Business Review) Selective Highlights as of January 26, 2021 *Filings/approvals assumed to be in the US and EU unless otherwise noted.
14.09.2020 · beerse, belgium-- ( business wire )--the janssen pharmaceutical companies of johnson & johnson today announced multiple data presentations from its oncology portfolio and pipeline, including key...