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Allergan and partner Gedeon Richter received FDA approval Thursday for antipsychotic Vraylar to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults. Read More
Addyi, the pill for premenopausal women with hypoactive sexual desire disorder, received FDA approval last month despite dissent from some reviewers that marginal clinical benefits did not outweigh the risks, an FDA summary said. Read More
Janssen and Pharmacyclics have submitted an sNDA for Imbruvica for front-line treatment for chronic lymphocytic leukemia, which, if approved, would provide patients who have not been treated with an alternative to chemotherapy. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee offered nearly unanimous support of CSL’s influenza vaccine Fluad, recommending the agency approve an accelerated pathway for use in people 65 and older against influenza types A and B. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including specified timelines for deciding applications and increased public access to applications and information. Read More
Drug and biologics makers are urging the Centers for Medicare & Medicaid Services to reimburse each noninterchangeable biosimilar based on its own average sale price, saying that would avoid prescribing mix-ups and possible harm to patient care. Read More