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Maroc Maroc - ZACKS.COM - All Stories - 11/Sep 16:04

ITRM Posts Updates From FDA Advisory Meeting for UTI Drug, Stock Down

Iterum provides updates from the FDA's Antimicrobial Drugs Advisory Committee meeting on its NDA for oral sulopenem to treat adult women with uUTI.

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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 Accepts AXSM's NDA Resubmission for Migraine Drug, Stock Up

zacks.com - 05/Sep 15:35

The FDA accepts Axsome's resubmission of the NDA for AXS-07 for the acute treatment of migraine. A decision is due on Jan. 31, 2025. Shares rise.

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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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Amneal Stock Rises 29% in a Month on Upbeat Regulatory Updates

zacks.com - 03/Sep 14:54

AMRX stock gains 29.3% in a month due to the FDA's approval of Parkinson's Disease drug, Crexont.

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Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug

zacks.com - 04/Sep 15:37

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS...

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Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug

zacks.com - 04/Sep 15:37

DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS...

Scientists discover marine microbes that break down plastic and create antibiotics 20:09

socialbites.ca - 04/Sep 17:21

An international team of scientists from China, Denmark and the UK has analysed nearly 43.2 thousand genomes of marine microorganisms, discovering...

Scientists discover marine microbes that break down plastic and create antibiotics 20:09

socialbites.ca - 04/Sep 17:21

An international team of scientists from China, Denmark and the UK has analysed nearly 43.2 thousand genomes of marine microorganisms, discovering...

MEETING PREVIEW: Transit Advisory Committee Meeting for September 19, 2024

guelphpolitico.ca - 13/Sep 13:32

Another committee that’s getting the band back together after summer vacation is the Transit Advisory Committee. With everyone back at school,...

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Pharma Stock Roundup: FDA Approves J&J's Tremfya for Ulcerative Colitis & More

zacks.com - 13/Sep 13:56

FDA approves J&J's Tremfya for ulcerative colitis. NVO's oral obesity pill, amycretin, shows faster weight loss than weekly injection, Wegovy.