Optina's 505(b)(2) filing strategy appears to be running into trouble with the FDA, according to Ampio's SEC filings.
Contrave will be resubmitted for FDA approval "within a few weeks," Orexigen said.
Biogen Idec and Gilead Sciences are helping the biotech sector recover from a sloppy fourth quarter performance.
European regulators decide Tecfidera is a "new active substance," clearing way for Biogen to begin selling the multiple sclerosis drug.
European regulators place new patient restrictions on Iclusig but Ariad can continue to sell the drug.
Biotech columnist Adam Feuerstein answers readers' questions about health care companies.
There are too many red flags to count in the way Oncolytics Biotech spins results from the Reolysin head and neck cancer study.
Amicus loses ground to rivals Sanofi and BioMarin in the race to develop drugs for rare, orphan diseases.
If this Kalydeco study is positive, Vertex will be able to market the drug to another 1,100 cystic fibrosis patients.
A heart drug from Anthera and a skin cancer vaccine from Vical caused patients harm, according to results from clinical trials presented Monday.
New rigosertib data to be presented next month should make investors feel more confident that Onconova has an active blood-cancer drug.
Lululemon's Wilson offers a transparent apology, JPMorgan invites abuse and much more.
An FDA panel will decide whether or not recommend the approval of Vanda's tasimelteon to treat a sleep disorder affecting blind people.
Traders can still profit from biotech and drug stocks even after shares have been decimated.
Imbruvica will be used to treated mantle cell lymphoma.
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