Pfizer and Myovant’s endometriosis pain drug Myfembree gets another FDA nod
After months of delay in its decision, the FDA has given a green light to Pfizer and Myovant’s drug Myfembree for pain related endometriosis, a gynecological condition associated with moderate to severe pain, making it the drug’s second indication approval.
The FDA had earlier delayed its decision to review additional data it had requested from the companies regarding bone mineral density. The regulators had “identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitment at this time,” the companies had said.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.