Less than a month after the U.S. Food and Drug Administration (FDA) gave its antidepressant drug zuranolone (Zurzuvae) a mixed welcome, Sage Therapeutics has launched plans to reorganize its operations by refocusing its drug development efforts and laying...
Canadian drugmaker Labopharm says its Italian API maker Gruppo Angelini has resolved all the US FDA concerns about processes used to make a once-a day version of the depression drug trazodone.
Biovail has this week sought to reassure its investors after the
news that US regulators issued the company with a Non Approval
letter for its new bupropion salt anti-depressant.
UK-headquartered pharma giant GlaxoSmithKline says it has overcome
the manufacturing problems that caused it to voluntarily withdraw
its antidepressant Paxil CR (paroxetine) and diabetes drug
Avandamet (metformin and rosiglitazone)...