US Food and Drug Administration (FDA)

Roche's takes a step- forward to treat Huntington's disease A new drug co-developed by Roche and Ionis Pharmaceuticals can be a potential candidate to treat Huntington's disease. RG6042 which is an antisense oligonucleotide is able to successfully lower down the production of a toxic protein that results in dysf...

Ovarian Cancer is a type of cancer that starts in Ovaries when the cells in the ovaries keep on dividing abnormally. It can affect either one or both the ovaries. Cancers that start in the ovaries can metastasize to other parts of the body. Ovarian cancer is not a single disease but can be defined as a cluster of d...

Gene therapy is a technique that involves replacing, inactivating, or adding a new gene to treat or prevent a disease. The science of GENE THERAPY involves the DNA-based changes in genetic material so that the gene can transcribe a healthy protein. In the past, there has been no success in designing any gene therap...

The hallucinogenic party drug, ketamine has passed the final problem for going into the clinical stage as an antidepressant. The US Food and Drug Administration (FDA), an independent advisory committee, supported in favour of commending a compound known as esketamine, used for treating depression. If the FDA giv...

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...

A digital pill is a tablet or capsule with embedded indigestible sensors that communicate about data outcomes related to when the medication is taken to a mobile application for access by the patient and treating their physicians. The novel digital pill system is designed to facili...

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...

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 ...

Two ongoing CAR-T Phase I trials of Cellectis drug candidate has been put on hold by FDA after a patient’s death FDA has put two CAR-T trials on hold following a patient’s death, less than a week after the first ever CAR-T was approved by the US regulatory agency.  The patient (78) was suffering from r...

Before approving an investigational drug, safety and effectivity needs to be proven. Something different happened with Sarepta’s Muscular dystrophy drug Eteplirsen, as its luck changed completely when the U.S. Food and Drug Administration on 19th September 2016 approved Sarepta Therapeutics' Exondys 51 (eteplirsen) ...