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The FDA and European Medicines Agency have accepted new drug applications for Boehringer Ingelheim’s Gilotrif as a treatment option for patients with advanced squamous cell lung cancer that has progressed after treatment with first-line chemotherapy. Read More
Novartis scored its second FDA approval for Promacta since acquiring the drug from GlaxoSmithKline in March, this time to treat children ages 1 to 5 with a rare blood disorder that causes low platelet counts. Read More
The proposal includes accelerated approvals of drugs, specified timelines for deciding applications and increased public access to information. Read More
The FDA has granted rare pediatric disease designation to two investigational Duchenne Muscular Dystrophy therapies — Sarepta Therapeutics’ eteplirsen and BioMarin Pharmaceutical’s drisapersen — the first DMD candidates to win the designation. Read More
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