Business Wire17h
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 ...
Healio3d
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, ...
JD Supra23h
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 ...
Targeted Oncology10d
FDA Clears Investigational New Drug Application for REC-4539 in SCLC
The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...
Healio26d
Glaukos submits new drug application for corneal cross-linking therapy
Please provide your email address to receive an email when new articles are posted on . Glaukos submitted a new drug application to the FDA for Epioxa, an epithelium-on corneal cross-linking iLink ...
Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
Science Daily1d
Scientists develop 'Malteser-like' molecules with potential applications in targeted drug delivery
Scientists have taken a major step forwards in tackling one of the greatest abiding challenges in chemistry, by learning how to program the self-assembly of molecules in such a way that the end result ...
Ozempic is in the next round of Medicare drug price negotiations. See the full list of 15 medications
The list includes Novo Nordisk’s blockbuster diabetes injection Ozempic, weight loss shot Wegovy and diabetes pill Rybelsus, ...
Medscape20h
FDA Approves New ADC for HR+, HER2- Breast Cancer
The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with ...
New Atlas1d
Got milk? Startup develops milk-based targeted drug-delivery technology
A couple of University of Nebraska professors have launched a startup company with the goal of bringing to market an ...
Morningstar11d
U.S. FDA Granted Priority Review to Dizal's Sunvozertinib New Drug Application
has accepted and granted priority review to the company's New Drug Application (NDA) for sunvozertinib, an oral EGFR inhibitor for the treatment of locally advanced or metastatic non-small cell ...
Drug Company to Share Revenues With Indigenous People Who Donated Their Genes
Variant Bio, a small biotech company based in Seattle, is using genetic information from Indigenous people to develop drugs ...