FDA grants priority review to Merck’s new biologics license application for V116
V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults
Laurus Synthesis receives Form 483 with 5 observations from USFDA
Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
Dr. Reddy's Laboratories has been issued a Form 483 with three observations
Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.
The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million
Norgestrel and Ethinyl Estradiol Tablets USP (RLD: Lo/Ovral-28) had estimated annual sales of US $33 million in the US
Decision on EU marketing authorisation expected for momelotinib by early 2024
The product will be manufactured at Lupin’s Nagpur facility in India
Subscribe To Our Newsletter & Stay Updated