Medscape4d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
The contents section serves as a navigational ... products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced ...
Morningstar4d
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 ... of our editorial content, we keep a strict ...
JD Supra7d
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 ...
ophthalmologytimes14d
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.
Business Wire7d
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 ...
Yahoo Finance26d
Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism
has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous ...
Yahoo Finance25d
Corcept Submits Application for Another Cushing's Syndrome Drug
Corcept Therapeutics Incorporated CORT recently announced the submission of a new drug application (NDA) to the FDA for its proprietary, selective cortisol modulator, relacorilant, to treat ...
Hosted on MSN1mon
Tonix Pharma Stock’s Retail Chatter Explodes After FDA Nod For New Drug Application
had accepted the company’s New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid analgesic for managing fibromyalgia, a chronic pain condition affecting over 10 million adults in the U ...
Cure Today21d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The Food and Drug Administration (FDA) has accepted a new drug application (NDA) with priority review for the investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) taletrectinib in the ...
Business Wire1mon
Epirium Bio Announces FDA Clearance of Investigational New Drug Application for MF-300 and Appointment of Alex Casdin as New Chief Executive Officer and Russell Cox as ...
has cleared the Company’s Investigational New Drug (IND) application for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor in ...