U.S. FDA declines to approve Vanda's stomach paralysis drug
The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' drug to treat stomach paralysis symptoms ...
Longboard Pharmaceuticals Receives Rare Pediatric Disease Designation and Orphan Drug Designation for Bexicaserin (LP352) in Dravet Syndrome
Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that the FDA ...
FDA approves Ebglyss for moderate-to-severe atopic dermatitis
The U.S. Food and Drug Administration has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for adults and children aged 12 ...
healthday2h
Some Chocolate Products Labeled 'Dairy-Free' Contain Milk, FDA Finds
Consumers should be aware that some chocolate labeled as “dairy-free” actually contains milk, the U.S. Food and Dru ...
FDA Rejects Vanda Pharma's Application for Gastroparesis Drug Tradipitant
Vanda said it will continue to pursue approval of tradipitant in gastroparesis, a condition that affects the stomach muscles and prevents proper stomach emptying, and that it plans to file a separate ...
TRUTH in Labeling Act would heighten the warning for shoppers looking to cut sugar, salt and saturated fat intake
If the legislation passes, the new label would be centered on the front of the package. But it’s an add-on, not a replacement ...
FDA to investigate metals found in tampons after study; study's co-author 'excited' over probe
The FDA will now investigate metals found in tampons following the results of a recent study. The study's co-author weighs in ...
STAT4h
FDA designates devices for heart surgery, smart knee implant as ‘breakthroughs’
The program gives manufacturers better access to regulators and the ability to design more flexible clinical trials.
Yahoo Finance6h
Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission
today announced significant progress following a productive meeting with the U.S. Food and Drug Administration (FDA). The company plans to resubmit its New Drug Application (NDA) for Dasynoc in Q4 ...
Winston-Salem Journal19h
Tobacco industry benefiting from more lenient FDA oversight
Barclays analyst Gaurav Jain said in a report released Sept. 13 that the industry is benefiting from four recent FDA ...
Medscape16h
FDA Approves Benralizumab for EGPA Vasculitis Indication
In a clinical trial, nearly 60% of participants achieved remission and 41% fully tapered off oral corticosteroids.
FDA expands use of Kisqali to early stage breast cancer patients
Women with early stage breast cancer may now take Kisqali, a medication already approved for advanced disease.