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Maroc Maroc - PHARMABIZ.COM - A la Une - 03/Aug 00:00

GSK announces US FDA expands Jemperli plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer

GSK plc announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult

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FDA Expands Approval of Omnipod 5 Insulin Delivery System to Include Patients With Type 2 Diabetes

drugs.com - 27/Aug 21:48

TUESDAY, Aug. 27, 2024 -- On Monday, the U.S. Food and Drug Administration approved the Insulet Omnipod 5 insulin delivery system for patients with...

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ILMN's TSO Comprehensive IVD Test Secures FDA Approval as CDx

zacks.com - 28/Aug 16:59

Illumina's cancer biomarker test, TSO Comprehensive, gets approved by the FDA for use as CDx to match patients with targeted therapies.

‘Significant milestone’ – EBR submits final PMA module to FDA

stockhead.com.au - 29/Aug 21:21

EBR Systems has submitted the final premarket approval (PMA) application module to the US Food and Drug Administration (FDA) for ...

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KalVista announces FDA acceptance of NDA for sebetralstat for oral on-demand treatment of HAE

haei.org - 03/Sep 17:29

KalVista announces FDA acceptance of New Drug Application for sebetralstat for oral on-demand treatment of hereditary angioedema KalVista...

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Emergent BioSolutions’ ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication

drugs.com - 29/Aug 04:08

GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...

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Emergent BioSolutions’ ACAM2000 (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication

drugs.com - 29/Aug 04:08

GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration...

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Travere Gains 11% on Securing Full FDA Nod for Kidney Disease Drug

zacks.com - 15:58

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

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Travere Gains 11% on Securing Full FDA Nod for Kidney Disease Drug

zacks.com - 15:58

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

Kenanga maintains 'outperform' on Karex after FDA approval

thestar.com.my - 28/Aug 03:22

KUALA LUMPUR: Kenanga Investment Bank Bhd maintained its "outperform" rating on Karex Bhd, setting a share target price of RM1.12 after the United...

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Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug

zacks.com - 04/Sep 15:37

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS...

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