Seeking Alpha15d
Interparfums, Inc. (IPAR) Q4 2024 Earnings Call Transcript
Interesting to notice is Travel Retail sales continued ... we are closely monitoring potential changes in US import and export taxes. Should these costs rise, we will explore all possible ...
Yahoo Finance11d
FDA recall notice details J&J pause of Varipulse
On Friday, the FDA published details of the investigation in a recall notice, explaining that the ... first two months of the U.S. launch had a form of stroke shortly after surgery.
Food Safety News6d
FDA increases import controls on some seafood and canned foods
The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Click here to go to the FDA page with links to ...
National Law Review4d
FDA Issues FSVP-Related Warning Letters
Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...
Food Safety News20d
FDA steps up import enforcement for pesticides, Salmonella and more import
The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Click here to go to the FDA page with links to ...
FiercePharma21d
FDA hits pair of Indian API makers with warning letters, import alerts
Both companies were placed on the FDA's import alert list as well ... The company previously received and responded to an FDA Form 483 tied to the inspection, but the U.S. drug regulator ...
FiercePharma15d
FDA dings Piramal API plant with Form 483 detailing problems tied to quality control, equipment cleaning and more
Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
Medical Xpress24d
FDA approves tablet form of Evrysdi for spinal muscular atrophy
The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA). The new tablet is ...
Business Insider18d
FDA gives Glaukos ‘Day 74’ notice for Epioxa NDA to treat keratoconus
Glaukos (GKOS) announced it has received the “Day 74” notification from the U.S. Food and Drug Administration FDA acknowledging the previously submitted New Drug Application NDA for Epioxa Epi ...
Rheumatology Advisor1d
FDA Approves Cortrophin Gel in Prefilled Syringe Presentation
The FDA has approved Purified Cortrophin Gel (repository corticotropin injection USP) in a prefilled syringe presentation.
Senate panel OKs Makary’s nomination as FDA commissioner
The Senate Committee on Health, Labor and Pensions voted Thursday to approve Marty Makary as commissioner of the Food and Drug Administration. He will likely be confirmed in the full Senate.