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FDA approves drug application for Lupin’s heart failure therapy
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
Joplin Globe5h
Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray
“We are pleased the FDA has accepted our NDA for Bumetanide Nasal Spray,” said Benjamin Esque, CEO of Corstasis Therapeutics Inc. “This milestone brings us closer to providing a simple, easy-to-use ...
Business Wire9d
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Shares of Ionis Pharmaceuticals (NASDAQ:IONS) climbed 7% today after the company announced that regulatory agencies in the ...
Managed Healthcare Executive3d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
ophthalmologytimes15d
FDA accepts revised supplemental New Drug Application for IZERVAY
The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose ...
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...
JD Supra9d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
Healio11d
FDA clears investigational new drug application for lorundrostat in OSA, hypertension
The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...
New approach uses peptides to enhance anti-tumor drug formulations
A team of scientists has developed a groundbreaking approach using specially designed peptides to improve drug formulations.
Morningstar10d
Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of ...