FiercePharma1d
FDA slaps China-based API makers with separate warning letters outlining quality, testing shortfalls
A pair of Chinese manufacturers with active pharmaceutical ingredients that were previously shipped to the U.S. | The FDA ...
Pharmabiz10d
US FDA completes pre-approval inspection of Lupin’s edaravone oral suspension facility in Somerset with no observations
US FDA completes pre-approval inspection of Lupin’s edaravone oral suspension facility in Somerset with no observations: Our Bureau, Mumbai Monday, February 3, 2025, 14:45 Hrs [ ...
Lupin's Somerset -based facility completes US FDA inspection with zero Form 483 observations
Lupin has announced that the the United States Food and Drug Administration (US FDA) has concluded the pre-approval inspection of the company's Edaravone Oral Suspension, located at its manufacturing ...
FDA Inspections Seminar: Fundamentals and the Ground Rules on How to Prepare for and Survive an FDA Inspection (ONLINE EVENT: February 24-25, 2025)
The "FDA Inspections: From Site Preparation to Response" training has been added to ResearchAndMarkets.com's offering. This is a practical, hands-on two-day seminar designed to provide pharmaceutical, ...
Conavi Medical Provides Shareholder Update and 2025 Outlook
U.S. FDA 510(k) filing of next-generation Novasight system targeted for H2 2025 with U.S. commercial launch planned for early 2026 ...
cnbctv1821d
Laurus Labs' US arm gets Form 483 from FDA after 'adverse experience' probe
Drug firm Laurus Labs Ltd on Wednesday (January 22) said its wholly-owned foreign subsidiary Laurus Generics Inc (LGI), based in Berkeley Heights, New Jersey, has received a Form 483 from the US Food ...
NBC News21d
Federal regulations paused, halting FDA's proposed ban on formaldehyde in hair products
Not all chemical hair relaxers include the chemical, but many include ingredients that can release formaldehyde when heated, the FDA said in 2024. Over the years, an increasing number of studies ...
Newsweek22d
FDA Approves Nasal Spray for Depression
However, it had to be used in conjunction with an oral medication. The FDA has now expanded its approval to include the standalone use of the nasal spray for adults with treatment-resistant major ...
The Pharma Letter22d
FDA sends Sanofi warning letter over quality violations
The facility, acquired through Sanofi's $20 billion purchase of Genzyme in 2011, previously received a Form 483 notice, which outlined preliminary concerns. The FDA has now deemed Sanofi’s response to ...
Popular Science22d
FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD ...
UPI22d
FDA approves Spravato, first monotherapy nasal spray to treat depression
Johnson & Johnson's Spravato has been approved to treat a major depressive disorder in adults who have had an inadequate response to at least two oral antidepressants, the FDA announced Tuesday.