Topic: advisory committee
All 12 members of an FDA advisory committee voted to recommend the approval of teprotumumab for a rare, autoimmune eye disease.
After Novartis’ near $10 billion buyout of The Medicines Company, many thought cardiovascular therapies were hot again.
In a 7-2 vote, an FDA panel backed Aimmune’s peanut allergy treatment for approval. It desensitizes patients with increasing doses of peanut protein.
In documents, the FDA stressed the difference between allergic reactions to the treatment and allergic reactions due to accidental exposure to peanuts.
Two months after Nektar Therapeutics handed off its lead pain drug to a new subsidiary, the FDA is postponing an advisory panel meeting for that drug.
Intra-Cellular Therapies’ lead asset hit a snag Tuesday afternoon as the FDA canceled an advisory panel meeting scheduled for next Wednesday.
The agency was less likely to go against a recommendation when the panellists were united in their opinion.