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Valeant Pharmaceuticals wasted no time in signing a deal to acquire Sprout Pharmaceuticals for $1 billion, following Tuesday’s FDA approval of Sprout’s female libido drug, Addyi. Read More
Allergan has resubmitted its sBLA for Botox, providing the FDA with additional study data on the effects of the injectable drug on lower limb spasticity. Read More
The FDA has approved the first treatment for sexual desire disorders, Sprout Pharmaceutical’s Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
Seattle Genetics has received FDA approval for its cancer drug Adcetris to treat patients with Hodgkin lymphoma who are at high risk of relapse following an autologous haematopoietic stem cell transplant to help curb the disease’s progression. Read More
Upsher-Smith Laboratories has launched its generic version of Actavis’ Alzheimer’s drug Namenda immediate release in the U.S. market, following FDA approval of an ANDA, the company said Aug. 10. Read More
Drugmakers will have to provide more benefit-risk information in common technical documents submitted to the FDA, European Medicines Agency and other regulators, under revised guidance from the International Conference on Harmonisation. Read More
The FDA has extended until Nov. 27 its deadline for deciding whether to approve Bristol-Myers Squibb’s sBLA for Opdivo in previously untreated advanced melanoma to allow the company to present additional data from a Phase 3 clinical trial. Read More