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Maroc Maroc - PHARMABIZ.COM - A la Une - 26/Jul 00:00

US FDA approves BioMarin's Brineura for children under 3 years with CLN2 disease

BioMarin Pharmaceutical Inc. announced that the US Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Brineura (cerliponase alfa) to

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KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

drugs.com - 03/Sep 20:09

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--Sep. 3, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S....

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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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FDA Approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

drugs.com - 12/Sep 08:09

South San Francisco, CA -- September 12, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S....

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FDA Approves Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

drugs.com - 12/Sep 08:09

South San Francisco, CA -- September 12, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S....

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Tremfya (guselkumab) Receives U.S. FDA Approval for Adults with Moderately to Severely Active Ulcerative Colitis

drugs.com - 13/Sep 07:09

HORSHAM, Pa. (September 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...

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Tremfya (guselkumab) Receives U.S. FDA Approval for Adults with Moderately to Severely Active Ulcerative Colitis

drugs.com - 13/Sep 07:09

HORSHAM, Pa. (September 11, 2024) – Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved...

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FDA extends review period for Medexus’ treosulfan to 2025

themarketherald.ca - 17:41

Medexus Pharmaceuticals (TSX:MDP) reveals the U.S. FDA has extended the review period for the company's new drug application for treosulfan.

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FDA extends review period for Medexus’ treosulfan to 2025

themarketherald.ca - 17:41

Medexus Pharmaceuticals (TSX:MDP) reveals the U.S. FDA has extended the review period for the company's new drug application for treosulfan.

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US: Biden-Harris administration marks major milestones for offshore wind, approves tenth project

energy pedia.com - 05/Sep 17:11

The Biden-Harris administration has announced the approval of the Maryland Offshore Wind Project – the nation’s tenth commercial-scale offshore...

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

pharmabiz.com - 11/Sep 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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