USFDA

US Food and Drug Administration (FDA) has approved Eli Lilly and Company Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog (insulin lispro 100 units/mL) Humalog U-200 KwikPen is used to improve glycemic control in people with type 1 and type 2 diabetes.

The Food and Drug Administration (FDA)  has approved Actavis' Viberzi (eluxadoline) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhoea (IBS-D).
IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and altered bowel function that affects as many as 15 million adult Americans, impacting about twice as many women as men. There are few treatment options available for IBS-D, particularly options that relieve both the diarrhea and abdominal pain associated with IBS-D.

US Food and Drug Administration (FDA) has approved  Neupogen, a drug originally used to treat side effects of chemotherapy,is the first ever approved for the treatment of acute radiation injury and the approval came as a result of research performed by the University of Maryland School of Medicine (UM SOM) scientists.

The US Food and Drug Administration (FDA) granted Orphan Drug Designation to Aura Biosciences' drug AU-011 for the treatment of uveal melanoma. The FDA’s Orphan Drug Designation programme provides orphan status to drugs and biologics, which demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions in the US.

Strides Arcolab Limited has got approval from the United States Food & Drug Administration (FDA) for lamivudine and zidovudine tablets USP, 150 mg/300 mg for HIV therapy.

AbbVie, a  research-based biopharmaceutical company, has been granted breakthrough therapy designation  to Venetoclax by the US FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

The US Food and Drug Administration (FDA) has approved Roche's cobas KRAS mutation test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumour samples from metastatic colorectal cancer (mCRC) patients and aid clinicians in determining a therapeutic path for them.

Nevro Corp., a medical device company focused on developing solutions in the neuromodulation spacea, has received approval from the United States Food and Drug Administration (FDA) for its Senza spinal cord stimulation (SCS) system. This is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

The US Food and Drug Administration (FDA) has accepted request by Biogen and AbbVie's Biologics License Application (BLA) for marketing approval of Zinbryta (daclizumab high-yield process) for the  treatment of multiple sclerosis (MS).

aTyr Pharma, a biotherapeutics company engaged in the discovery and development of physiocrine-based therapeutics to address rare diseases, announced  that Resolaris has been granted Orphan Drug designation by the US Food and Drug Administration (FDA) for the treatment of facioscapulohumeral muscular dystrophy (FSHD).  Resolaris, an investigational new drug,  is being developed as a first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component.