The FDA is reviewing supplemental Biologics License Applications for golimumab to treat polyarticular JIA and juvenile PsA…
U.S. FDA Warns Against Using Hydroxychloroquine for COVID-19
(Reuters)—On April, the U.S. Food and Drug Administration (FDA) cautioned against the use of malaria drug hydroxychloroquine (HCQ) in COVID-19 patients even as President Donald Trump, who has touted it as a “game changer,” advocated for an additional review. The drug, first approved in 1955, provided no benefit and potentially higher risk of death for…
FDA Cautions Slower Drug Review Activity Due to Staff Reallocation for COVID-19
(Reuters)—On April 16, the U.S. Food & Drug Administration (FDA) cautioned that with a lot of its staff allocated to the coronavirus crisis, it may not be able to sustain its current level of timely reviews and approvals of marketing applications. FDA says it was working to ensure that the drug programs continue to see…
FDA Considers Tanezumab Application for Chronic OA Pain
The FDA is considering an application for subcutaneous tanezumab, a monoclonal antibody, as a treatment for moderate to severe osteoarthritis…
FDA Approves Meloxicam Injection & OTC Diclofenac Sodium Topical Gel for Pain Management
The FDA has approved two pain medications: meloxicam in an injection and over-the-counter diclofenac sodium topical gel 1%…
FDA Accelerates Approvals of Generic Versions of HCQ
On April 7, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of: 1) uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; 2) chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and 3) treatment of acute and chronic…
Tocilizumab Begins Clinical Trial for COVID-19
The FDA has authorized a phase 3 clinical trial examining the safety and efficacy of tocilizumab plus standard care in patients hospitalized with COVID-19…
U.S. FDA Says HCQ & Other Malaria Drugs in Shortage as COVID-19 Drives Up Demand
April 1 (Reuters)—The U.S. Food and Drug Administration (FDA) said malaria drugs hydroxychloroquine and related chloroquine are in shortage due to a surge in demand because of the coronavirus pandemic. The drugs, which have been tried with some success to treat the illness caused by the virus, were added to the agency’s website that lists…
Roche Gets FDA Nod for Trial to Test Arthritis Drug on COVID-19 Patients
March 23 (Reuters)—Roche Holding AG said on Monday it has received the U.S. Food and Drug Administration‘s clearance to test its rheumatoid arthritis treatment on patients hospitalized with severe pneumonia caused by the coronavirus. The company said it was beginning a late-stage study to test the drug in what would be the first well-controlled study…
FDA Advisory Committees Reject Oxycodegol (NKTR-181) Application
FDA advisory committees rejected the new drug application for oxycodegol, an opioid analgesic, due to a lack of data regarding it’s potential for abuse…
- « Previous Page
- 1
- …
- 3
- 4
- 5
- 6
- 7
- …
- 28
- Next Page »