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FDA Accepts Regulatory Submission and Grants Priority Review for Lofexidine americanpharmaceuticacreview
November 22, 2017
Priority Review is granted to submissions for medications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
FDA approves first two-drug regimen for certain patients with HIV fda
November 22, 2017
FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1).
FDA Approves AUVI-Q 0.1 mg Auto-Injector americanpharmaceuticacreview
November 21, 2017
The new 0.1 mg-dose epinephrine auto-injector has a shorter needle length and lower dose of epinephrine than current FDA approved 0.15 mg and 0.3 mg epinephrine auto-injectors.
FDA asks that Baxter saline plants in Puerto Rico get power restored ahead of others fiercepharma
November 20, 2017
The FDA has been helping dozens of U.S. drugmakers in Puerto Rico get power and supplies to their plants in the wake of the infrastructure disaster left by hurricanes Irma and Maria.
FDA OKs behind-the-ear device for opioid withdrawal fiercebiotechFDA OKs behind-the-ear device for opi
November 20, 2017
Innovative Health Solutions has bagged an FDA clearance for its nerve field stimulator that treats the symptoms of opioid withdrawal.
FDA Expands Approval of Sutent americanpharmaceuticacreview
November 20, 2017
Adjuvant treatment is a form of therapy that is taken after an initial surgical removal to lower the risk of the cancer coming back.
FDA approves first telehealth option to program cochlear implants remotely fda
November 20, 2017
FDA approved the first telehealth option to program cochlear implants remotely
FDA expands use of Pfizer's Sutent in kidney cancer pharmafile
November 20, 2017
Pfizer has announced that the FDA has expanded the use of its tyrosine kinase inhibitor Sutent to include the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma– the most common kind of kidney cancer – following nephrectom
Roche nabs blockbuster FDA approval for Hemlibra, big label expansion for Gazyva fiercepharma
November 17, 2017
Hemlibra won the agency's backing to prevent or reduce bleeding in adults or children with hemophilia A who have developed antibodies called Factor VIII inhibitors.
FDA Approves Treatment for Rare Genetic Enzyme Disorder americanpharmaceuticacreview
November 17, 2017
The FDA is requiring the manufacturer to conduct a post-marketing study to evaluate the long-term safety of the product.

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