Ipsen Biopharmaceuticals, Inc.
NEWS
Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
Boehringer Ingelheim will launch three Phase III studies for its obesity drug candidate; third time is a charm for Ipsen as it gets FDA approval; and Pfizer takes multiple myeloma battle to J&J.
After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.
The FDA has four decisions on deck this week, including ones for two rare disease treatments from Ipsen and Regeneron.
The first half of this year saw milestone approvals for rare disease therapies, and the FDA has several more such decisions on its calendar in the second half of 2023.
The companies Friday reported positive late-stage results for elafibranor as a second-line treatment for primary biliary cholangitis, a rare liver disease.
An FDA advisory committee voted Wednesday that Ipsen’s fibrodysplasia ossificans progressive candidate palovarotene was effective and the benefits of the drug outweighed its risks.
The FDA has four target action dates this week for three supplemental approvals and one New Drug Approval.
Phase III data showed Ipsen’s Onivyde boosted overall survival in metastatic pancreatic ductal adenocarcinoma.
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