Ipsen’s tyrosine kinase inhibitor, Cabometyx, is the first product to be registered under a new Australian procedure that aims to get prescription drugs to market faster by using medicine assessments already conducted by comparable overseas regulators.
Ipsen has become the first company to get a product registered under a new pathway in Australia that allows the Therapeutic Goods Administration to speed up prescription drug approvals by making use of medicine assessments conducted by a comparable overseas regulator, or COR.
A new indication for the company’s renal cancer drug, Cabometyx (cabozantinib), was placed on the Australian Register of Therapeutic Goods...
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
After the abrupt departure of CBER’s director, it seems FDA, and Vinay Prasad in particular, would likely have been well served by hearing from an advisory committee before requesting the suspension in sales of Sarepta’s DMD gene therapy Elevidys.
