Forest Laboratories has a slate of new products meant to be its life raft. But what happens when one of those new products--the antipsychotic drug cariprazine--gets a thumbs down from the FDA?
The FDA set up a potentially serious roadblock for Forest Laboratories and its partner Gedeon Richter, rejecting their application for the schizophrenia/bipolar drug cariprazine and likely delaying any possible approval until the agency gets additional clinical trial data.
GE Healthcare has gotten FDA approval for its plant in Oslo, Norway, to make a heart imaging agent. The company said that with approval, it will be the only contrast media manufacturer to supply its own stock to the U.S.
Roche's Kadcyla, a drug some refer to as a "super Herceptin," was approved by the European Commission Wednesday for patients with previously treated HER2-positive advanced breast cancer.
Actinium Pharmaceuticals spoke with the FDA last week and is now planning to roll out a Phase III pivotal trial of its targeted immunotherapeutic cancer treatment using its radioisotope delivery platform.
Qiagen won Chinese regulatory approval for a next-generation tuberculosis test and expects a commercial rollout there in the early part of 2014.
The Bay Area's BioMarin Pharmaceutical had an easy time at the FDA, winning the support of an agency panel for its latest rare-disease treatment and feeding expectations for a near-term approval.
Boston Scientific's Vercise deep brain stimulation system isn't yet approved in the U.S., but it continues to rack up regulatory blessings overseas. In the latest advance, the product now has a CE mark to treat a neurological movement disorder known as dystonia.
The FDA has accepted an NDA for Nektar Therapeutics' naloxegol, triggering a $70 million milestone payment from partner AstraZeneca.
With Gilead's pioneering hepatitis C drug sofosbuvir moving closer to a likely approval and a megablockbuster market, AbbVie is looming from behind with some promising results from the first of 6 Phase III studies of its breakthrough triple-threat therapy.