FDA Approves Drug To Calm Cats During Vet Visits
Known as Bonqat, this newly-approved pill is designed to alleviate acute anxiety and fear that cats may experience during travel or vet visits
Dr. Reddy's scolded for maintenance shortfalls in new FDA Form 483 filing
In a 10-observation write-up, the FDA chided Dr. Reddy’s for missteps around building and equipment maintenance, deficient quality control activities, mishandling of complaints and more.
Biotech Stocks Facing FDA Decision In December 2023
So far, this year, the FDA has approved 52 novel drugs compared to just 37 for the full year of 2022.
Strides Pharma receives FDA OK for 2 generics
Strides Pharma has obtained the Food and Drug Administration’s approval for two generics.
FDA Releases Small Entity Compliance Guide
Manufacturers must begin complying with the rule for products labeled on or after January 1, 2024.
Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Dusquetide in the Treatment of Aphthous Ulcers in Behçet's Disease
The study is designed to evaluate the safety and efficacy of SGX945 (dusquetide) and is expected to begin patient enrollment in the second half of 2024.
Imugene’s oncolytic virus VAXINIA granted FDA’s Fast Track, but how effective is this novel therapy?
Bile duct cancer is a rare disease in which malignant (cancer) cells form in the bile ducts. This cancer is known to be difficult to treat, and typically responds poorly to drugs.
FDA proposes ban on hair-straightening products containing potential cancer-causing chemicals
This comes after studies that show women who frequently use the products are at a higher risk of uterine, ovarian, and breast cancer.
Orchard Therapeutics: FDA Grants Fast Track Designation To OTL-203
An investigational hematopoietic stem cell gene therapy being developed for the potential treatment of the Hurler subtype of mucopolysaccharidosis type I.