Rheumatoid arthritis (RA) disease activity and inflammatory markers are associated with major adverse cardiovascular events (MACEs) in biologic disease-modifying antirheumatic drug (bDMARD) nonusers ...
Add Yahoo as a preferred source to see more of our stories on Google. Draft guidance from the FDA would allow companies to scale back on the studies and trials needed to prove that a biosimilar ...
The Food and Drug Administration said it will be taking steps to speed up the approval process for developing generic biological drugs, an effort aimed at increasing cheaper competition among ...
If the Trump White House is serious about its push to make medicines more affordable, it should ensure CMS officials never ...
Lonza officials say they have expanded the company’s service offering for orally delivered biologic therapies to support the unique development and manufacturing needs of smart capsule companies. Oral ...
Biologic drugs have improved how doctors treat serious illnesses. Instead of being made from chemicals, biologics are made from organic materials and grown in living cells. Biologic drugs are used ...
Federal regulators are trying to make it easier to develop cheaper alternatives to powerful drugs that many Americans depend on to treat autoimmune diseases or cancers. The Food and Drug ...
This article originally appeared on PolitiFact. If you watch TV and don't mute ads, you've probably heard of a few biologics. They're drugs such as Humira for arthritis and Trulicity for Type 2 ...
The Biologics Price Competition and Innovation Act of (BPCI Act) of 2009 granted responsibility to the FDA for review and approval of a new class of pharmaceuticals referred to as “Biosimilars.” (1) ...
Biologic drugs are a newer treatment option for chronic rhinosinusitis with nasal polyps. They work differently from other treatments. Nasal polyps are small, noncancerous growths that develop in the ...