X

Vous n'êtes pas connecté

Maroc Maroc - DRUGS.COM - New Drug Applications - 16/Jul 21:07

Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission

The Woodlands, Texas, July 16, 2024 - Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista&trade...

Articles similaires

Sorry! Image not available at this time

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....

Sorry! Image not available at this time

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...

Sorry! Image not available at this time

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.

Sorry! Image not available at this time

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.

Sorry! Image not available at this time

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.

Sorry! Image not available at this time

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...

Sorry! Image not available at this time

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...

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...

Sorry! Image not available at this time

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,...

Sorry! Image not available at this time

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...