10 US Approval Decisions To Look Out For In Q3
This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.
You may also be interested in...
The company set a $26,400 per month list price for the HIF-2α inhibitor in its first US FDA-approved indication of VHL disease-associated tumors, but the drug is being studied in broader populations.
The Swiss group has posted a solid if unspectacular set of six-month results and is "working on a number of opportunities" that should close by the end of the year, according to its CFO.
The European Medicines Agency decided this month whether to grant fast-track review for planned marketing authorization applications for three potential new orphan treatments.