FDA

Sep 12, 2018

Aimovig of Amgen commence robust for migraine treatment The U.S. Food and Drug Administration (FDA) has given the approval to preventative migraine treatment, Aimovig of Amgen. Aimovig has a price of USD 6,900 per year, but according to analysis of sales, it gives information that migraine treatment is making its wa...

Sep 11, 2018

Nucala of GlaxoSmithKline exhibits splendid benefits to other IL-5 Inhibitors in Asthma, however flunks as a COPD Drug A Complete Response Letter is received by GSK from the U.S. Food and Drug Administration (FDA) for Nucala (mepolizumab) as COPD treatment. Nucala, which targets the IL-5 pathway, was initially appro...

Sep 05, 2018

Merck & Company virology business is flickering, after announcing two of its new HIV medications that bagged approval from the Food and Drug Administration (FDA). The oral medications, Pifeltro and Delstrigo, are taken once-daily with or without food for adult HIV-1 patients, who have never received antiretrovir...

Sep 04, 2018

Food and Drug Administration repudiates ADHD drug by Sunovion Sunovion’s ADHD drug for the treatment of attention-deficit hyperactivity disorder (ADHD) has not been accepted by the Food and Drug Administration, FDA. It is so because the drug for ADHD treatment in its current form needs additional clinical trials and...

Sep 04, 2018

The Orphan Drug Act of 1983 was created to encourage pharmaceutical companies to develop drugs for so-called rare or ultra-rare diseases. The National Institutes of Health (NIH) defines rare diseases as afflicting as fewer than 200,000 individuals. Generally speaking, it has worked. Many companies are willing to inv...

Aug 31, 2018

Use of Placebo is Necessary Only in Certain Types of Oncology Trials: USFDA In a new draft guidance released, the USFDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary. The FDA said sometimes the use of a placebo can present practical or ethical co...

Aug 31, 2018

AbbVie Receives USFDA Approval for Imbruvica Plus Rituximab as First Chemotherapy-Free Combination Treatment for Waldenström's Macroglobulinemia Adults AbbVie announced that the USFDA approved Imbruvica (ibrutinib) plus rituximab (Rituxan) for the treatment of adult patients with Waldenström's macroglobulinemia (W...

Aug 30, 2018

For all-in-one dialysis system, Outset Medical captures USD 132 Million to extend U.S. expansion Outset Medical bagged USD132 Million in series D capital. This ensued in encouraging the production capabilities and accelerating the commercial expansion for all-in-one dialysis system. The FDA cleared the Tablo Hemodia...

Aug 22, 2018

HOA Puts into Operation of Updated CyberKnife Version Cancer patients now have a solid reason to cheer, as US-based Hematology-Oncology Associates (HOA) lately came up with the new CyberKnife (CK) and replaced their original CyberKnife with an updated that is even more precise, fast and effective, and known as the ...

Aug 21, 2018

Kalydeco, the first Cystic Fibrosis drug of Vertex, got approved for infants The Food and Drug Administration has cleared Kalydeco drug of Vertex Pharmaceuticals for infants aged 12 to under 24 months. The approved drug treats the underlying cause of cystic fibrosis in children of this age with at least one mutatio...