FDA accepts Otsuka’s centanafadine application for ADHD treatment

The US Food and Drug Administration (FDA) has accepted for priority review Otsuka Pharmaceutical’s new drug application (NDA) ...
Healio

FDA clears investigational new drug application for NOV05

The FDA cleared an investigational new drug application to advance NOV05 in a phase 2 clinical trial in noninfectious ...
CURE

FDA Accepts Gedatolisib Application for Some With Breast Cancer

The U.S. Food and Drug Administration (FDA) has accepted a new drug application for gedatolisib in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA ...

Aspire Biopharma Files Provisional Patent Application for Industry-First Sublingual Powder Formulation of Clopidogrel (Generic Plavix(R)) to Address Gastric Bleeding Risks

New sublingual delivery system designed to enhance bioavailability and avoid gastric side effects many patients experience with clopidogrel.
Nasdaq

Silo Pharma Files Patent Application for Alzheimer's Drug SPC-14 Targeting Novel Mechanism of Action

Silo Pharma, Inc. has announced the filing of a patent application for its neurology drug, SPC-14, which is an intranasal treatment for Alzheimer's disease. This compound, licensed from Columbia ...
MPR

Subcutaneous Lecanemab Starting Dose Under Review for Alzheimer Disease

Previously lecanemab was only approved as an SC injection for maintenance dosing, following an initial 18 month IV phase.
Morningstar

NEW DRUG APPLICATION FOR TINENGOTINIB TABLETS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been ...
Nasdaq

Achieve Life Sciences Submits New Drug Application for Cytisinicline to Treat Nicotine Dependence in Adults

Achieve Life Sciences, Inc. has submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, which, if approved, would be the first new pharmacotherapy for nicotine dependence in 20 years ...

Legal questions swirl around FDA's new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...
Healio

FDA accepts new drug application for SYD-101 to treat pediatric myopia progression

Please provide your email address to receive an email when new articles are posted on . The new drug application is supported by 3-year data from the STAR study. If approved, SYD-101 would be the ...
Wall Street Journal

Novo Nordisk Says FDA Accepted New Drug Application for Wegovy Pill

Novo Nordisk NOVO.B9.24%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...
Ophthalmology Times

FDA clears Novaliq’s Investigational New Drug application for NOV05

The US Food and Drug Administration (FDA) has cleared Novaliq’s Investigational New Drug (IND) application for NOV05, enabling the initiation of the EYETAC phase II clinical trial ( NCT07285070) in ...