FDA

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Use of Placebo is Necessary Only in Certain Types of Oncology Trials: USFDA In a new draft guidance released, the USFDA is questioning whether or not the use of a placebo in a double-blind, randomized clinical trial is always necessary.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

Apr 24, 2018

FDA still not completely satisfied with Kamada’s inhaled AAT drug(Synthetic Biologics) Kamada is stuck again with a new obstacle in its way to bring the first inhaled treatment for alpha-1 antitrypsin (AAT) deficiency in the market as an alternative to currently present intravenous drugs. The company specializes in ...

Mar 14, 2018

Sanofi and Regeneron Pharmaceuticals got effective results in reducing the risk of major adverse heart events in a clinical study of nearly 19,000 patients with the help of cholesterol drug Praluent. Drugmakers now hope that the results are good enough to convince insurers to pay for the pricey medicine. Treatment w...

Feb 06, 2018

Charles River to fuel hit discovery with AstraZeneca high-throughput collaboration After collaborating with AstraZeneca Charles River is now looking forward to strengthening its high-throughput screening capabilities (HTC) with the help of highly advance AstraZeneca technology. Now the company is able to offer the ...

Jan 19, 2018

Familial Amyloid Polyneuropathy (also known as transthyretin amyloidosis, TTR, and FAP) is a group of endangering multisystem disorders which are transmitted as an autosomal dominant trait. It is caused by the excessive accumulation of amyloid in the organs and tissues. The first identified cause of FAP is the Val30...