FDA

Sep 27, 2018

Ceribell raises USD 35 Million in series B round Ceribell, Emergency EEG maker raised USD 35 million for commercializing its EEG system that can rapidly diagnose patients, who are supposed of not having convulsive seizures with no visual symptoms for the use in neurological intensive care units and emergency rooms. ...

Sep 25, 2018

The interleukin-33 antibody of AnaptysBio passes midstage test in asthma The pipeline drug, etokimab of AnaptysBio, has positive data in a third indication that adds asthma to one of its triumphs. The US-based company gets another proof-of-concept study for the interleukin-33 (IL-33) inhibitor, because of phase 2a ...

Sep 18, 2018

Argenx gets green cue in phase 2 in primary immune thrombocytopenia The Belgian biotech, Argenx has cleared phase 2 data on efgartigimod in primary immune thrombocytopenia (ITP). The results that they received, indicate at the effectiveness of the antibody Fc fragment in patients with the autoimmune bleeding disord...

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...