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Maroc Maroc - DRUGS.COM - Clinical Trials News - 18/Jul 00:07

FDA Clears Investigational New Drug application for muscular dystrophy treatment

MINNEAPOLIS and ST. PAUL, Minn., July 17, 2024. Today, Myogenica, a University of Minnesota startup company, announced U.S. Food and Drug Administration approval for an Investigational New Drug (IND) application for MyoPAXon — an induced...

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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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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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Indies Pharma looking to double sales after securing FDA drug approval

jamaica-gleaner.com - 11/Sep 05:05

Drug company Indies Pharma Jamaica Limited is looking to double next year’s revenues, following approval of its abbreviated new drug application,...

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A More Efficient FDA Approval Process: An Expert’s Proposal

theparadise.ng - 06/Sep 00:50

The Food and Drug Administration (FDA), as many are aware, is the leading entity for the regulation and safety testing for foods and pharmaceuticals...

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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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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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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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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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