The FDA is considering a supplemental biologics license application for tocilizumab to treat giant cell arteritis…
FDA Approves Valeant’s Drug to Treat Plaque Psoriasis
(Reuters)—The U.S. Food and Drug Administration has approved Valeant Pharmaceuticals International Inc.’s brodalumab (Siliq) to treat adults with moderate to severe plaque psoriasis. Brodalumab is administered as an injection. Brodalumab is intended for patients who are candidates for systemic therapy or phototherapy and have failed to respond, or have stopped responding to other systemic therapies,…
Biosimilar Update: ACR Says FDA Draft Guidance Is Promising & Biosimilar to Humira (Adalimumab) Enters Regulatory Review
The ACR has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development. Also, BI 695501, a biosimilar to Humira (adalimumab) made by Boehringer Ingelheim, has been accepted for regulatory review in both the U.S. and Europe. ACR Responds to FDA Biosimilar…
FDA Update: FDA Delays Baricitinib Review & Removes Bupropion & Varenicline Warnings
FDA Review of Baricitinib Delayed The U.S. Food and Drug Administration (FDA) has extended the review period for baricitinib, an investigational medication for treating moderate to severe rheumatoid arthritis (RA).1 Baricitinib is a once-daily oral Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The New Drug Application (NDA) for baricitinib…
Updated EULAR Recommendations for Early Arthritis; Plus FDA Approves New Abuse-Deterrent Morphine Sulfate
EULAR has updated its recommendations for the management of early arthritis, outlining aspects of diagnosis and drug treatments…
FDA Releases Biosimilar Guidance, Medicare Will Cover Infliximab-dyyb & More
The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…
FDA Update: FX006 Promising for Knee OA; Pioglitazone Linked to Bladder Cancer Risk; & HIV Drug Gets New Labeling
The makers of FX006, a steroid injection for treating pain in patients with knee osteoarthritis, have submitted a new drug application to the FDA…
Trump Considering Dr. Scott Gottlieb to Head U.S. FDA
(Reuters)—Dr. Scott Gottlieb, a partner at one of the world’s largest venture capital funds and a former deputy commissioner at the U.S. Food and Drug Administration, is being considered by President-Elect Donald Trump to run the agency, according to sources close to the transition team. Gottlieb, 44, a venture partner at New Enterprise Associates and…
Celecoxib & Cardiovascular Death: NSAID Safety Under Review
A recent study showed that at moderate doses celecoxib may be noninferior with respect to cardiovascular safety compared with ibuprofen or naproxen…
FDA Update on Rituximab & Etanercept; Plus New ACP Gout Guideline
The FDA is considering an application for subcutaneous rituximab and has approved an application for etanercept to treat pediatric patients with plaque psoriasis…
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