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Maroc Maroc - DRUGS.COM - Clinical Trials News - 20/Aug 02:08

GSK Receives US FDA Breakthrough Therapy Designation for B7-H3-Targeted Antibody-Drug Conjugate GSK5764227 in Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer

20 August 2024 -- GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), the Company’s investigational B7-H3-targeted antibody drug...

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Corvus Stock Up on Initiation of Phase III Lymphoma Study on Lead Drug

zacks.com - 14:47

CRVS stock gains 14% on initiating a registrational study on its lead candidate, soquelitinib, to treat relapsed/refractory peripheral T-cell...

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Merakris Therapeutics Announces FDA Clearance for Part 2 of its Phase II Multicenter Investigational New Drug Study of Dermacyte® Liquid

healthtechzone.com - 05/Sep 10:30

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Merakris Therapeutics Announces FDA Clearance for Part 2 of its Phase II Multicenter Investigational New Drug Study of Dermacyte® Liquid

healthtechzone.com - 05/Sep 10:30

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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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Indoco Remedies receives US FDA final approval to market generic Lucemyra tablets

pharmabiz.com - 12:11

Indoco Remedies Limited (Indoco) announced the receipt of final approval from the US FDA for Abbreviated New Drug Application (ANDA) for lofexidine...

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Indoco Remedies receives US FDA final approval to market generic Lucemyra tablets

pharmabiz.com - 12:11

Indoco Remedies Limited (Indoco) announced the receipt of final approval from the US FDA for Abbreviated New Drug Application (ANDA) for lofexidine...

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CellProthera shares US regulatory progress of ProtheraCytes cell therapy programme

pharmabiz.com - 31/Aug 00:00

CellProthera, a regenerative cell therapy developer specialising in ischemic diseases, announced alignment with regulators on a planned pivotal phase...

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Neurotech chases another orphan drug designation

stockhead.com.au - 30/Aug 02:11

Neurotech has submitted a request with the US Food and Drug Administration for orphan drug designation (ODD) for use of ...

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