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Maroc Maroc - DRUGS.COM - New Drug Applications - 29/Aug 23:08

Johnson & Johnson Seeks First Approval of Nipocalimab to Treat Broadest Population Living with Antibody Positive Generalized Myasthenia Gravis

Spring House, Pa. (August 29, 2024) – Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of nipocalimab globally for the...

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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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More ASF vaccine makers seek FDA nod–DA

businessmirror.com.ph - 11/Sep 13:06

Providers of vaccines against African swine fever (ASF) from four countries are seeking the Food and Drug Administration’s (FDA) approval, according...

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More ASF vaccine makers seek FDA nod–DA

businessmirror.com.ph - 11/Sep 13:06

Providers of vaccines against African swine fever (ASF) from four countries are seeking the Food and Drug Administration’s (FDA) approval, according...

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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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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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Roche Gets FDA Approval for Subcutaneous Formulation of Tecentriq

zacks.com - 13/Sep 16:54

The FDA approves subcutaneous formulation of RHHBY's leading immunotherapy drug, Tecentriq, under the brand name Tecentriq Hybreza.

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Unicycive Therapeutics Announces Submission of the New Drug Application (NDA) to the U.S. FDA for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis

drugs.com - 03/Sep 01:09

LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing...

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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....