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Maroc Maroc - DRUGS.COM - New Drug Applications - 16/Aug 23:08

U.S. Food and Drug Administration Accepts for Priority Review Deciphera’s New Drug Application for Vimseltinib for the Treatment of Patients with Tenosynovial Giant Cell Tumor (TGCT)

Osaka, Japan and Waltham, Massachusetts, August 16, 2024 – Ono Pharmaceutical, Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) today announced that the U.S. Food and Drug Administration (FDA) accepted a...

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SWTX's NDA for Rare Tumor Drug Gets Priority Review From FDA

zacks.com - 29/Aug 15:52

The FDA accepts and grants priority review to SpringWorks' NDA for mirdametinib for treating neurofibromatosis type 1-associated plexiform...

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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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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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Soleno Stock Up as FDA Accepts PWS Drug NDA Under Priority Review

zacks.com - 28/Aug 14:25

SLNO stock gains 6.3% as FDA accepts regulatory filing for lead candidate, DCCR, to treat hyperphagia associated with PWS under Priority Review.

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FDA authorizes Novavax's updated COVID vaccine targeting JN.1 strain

thestar.com.my - 30/Aug 18:54

(Reuters) -The U.S. Food and Drug Administration on Friday granted emergency use authorization for an updated version of Novavax's COVID shot. Read...

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‘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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FDA Mandates ID Checks for Everyone Younger Than 30 Buying Cigarettes

drugs.com - 30/Aug 22:38

FRIDAY, Aug. 30, 2024 -- Retailers will now be required to check the IDs of anyone buying cigarettes who is younger than 30 years of age, the U.S....

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

drugs.com - 29/Aug 23:08

Spring House, Pa. (August 29, 2024) – Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and...

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