Subscribe
Home
Issues
Issue Archive
Latest Issue
Special Issues
Browse By Topic
Web Exclusives
All Web Exclusives
FDA Approvals, News & Updates
In the News
Press Releases
Submit an Article
Author Guidelines
About
About RPM
Mission Statement
Contact Us
Web Exclusives
In the News
In the News
Biosimilar to Etanercept FDA Approved for Inflammatory Diseases
FDA Approvals, News & Updates
,
In the News
The US Food and Drug Administration (FDA) has approved etanercept-szzs, a biosimilar to etanercept (Enbrel), for the treatment of multiple inflammatory diseases, according to an announcement by the organization. The biosimilar injection has been approved to treat patients with moderate-to-severe rheumatoid arthritis; moderate-to-severe polyarticular juvenile idiopathic arthritis; active psoriatic arthritis; active ankylosing spondylitis; and chronic, moderate-to-severe plaque psoriasis.
Read More ›
FDA Enhances Warnings for Serious Risks of Opioid Analgesics Abuse
FDA Approvals, News & Updates
,
In the News
Immediate-release opioid analgesics will now require boxed warnings regarding the serious risks for abuse, addiction, overdose, neonatal opioid withdrawal syndrome (NOWS), and death associated with the drugs, according to an announcement by the US Food and Drug Administration (FDA). This is the latest in a number of steps recently outlined by the FDA in their bid to reassess their approach to opioid medications.
Read More ›
Ixekizumab FDA-Approved for Patients with Plaque Psoriasis
FDA Approvals, News & Updates
,
In the News
Ixekizumab (Taltz) has been approved by the US Food and Drug Administration (FDA) for use in patients with moderate-to-severe plaque psoriasis, the agency has announced. Administered as an injection, ixekizumab is an antibody that binds and inhibits the inflammatory response of the inflammation-causing interleukin-17A protein.
Read More ›
FDA Approves Infliximab Biosimilar for Multiple Indications
FDA Approvals, News & Updates
,
In the News
The US Food and Drug Administration (FDA) announced the approval of Inflectra (infliximab-dyyb)—a biosimilar to Remicade (infliximab)—for patients with chronic severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis. The biosimilar is also indicated for adult patients with moderately to severely active ulcerative colitis who have inadequately responded to standard therapy; in combination with methotrexate for patients with moderately to severely active rheumatoid arthritis; and patients aged ≥6 years with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Inflectra is the second biosimilar approved by the FDA.
Read More ›
FDA Approves New Oral Therapy to Treat ALK-Positive Lung Cancer
FDA Approvals, News & Updates
,
In the News
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).
Read More ›
FDA Approves First Emergency Treatment for Overdose of Certain Types of Chemotherapy
FDA Approvals, News & Updates
,
In the News
The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.
Read More ›
FDA Approves Darzalex for Patients with Previously Treated Multiple Myeloma
FDA Approvals, News & Updates
,
In the News
Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.
Read More ›
FDA Approves Ninlaro, New Oral Medication to Treat Multiple Myeloma
FDA Approvals, News & Updates
,
In the News
Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy.
Read More ›
FDA Approves New Pill to Treat Certain Patients with Non—Small-Cell Lung Cancer
FDA Approvals, News & Updates
,
In the News
Today, the US Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non—small-cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (
T790M
) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.
Read More ›
FDA Approves Cotellic as Part of Combination Treatment for Advanced Melanoma
FDA Approvals, News & Updates
,
In the News
The US Food and Drug Administration (FDA) today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (
BRAF V600E
or
V600K
mutation).
Read More ›
December 2021, Vol 9, No 1
Read Now
Home
Issues
Issue Archive
Latest Issue
Special Issues
Browse By Topic
Web Exclusives
All Web Exclusives
FDA Approvals, News & Updates
In the News
Press Releases
Submit an Article
Author Guidelines
About
About RPM
Mission Statement
Contact Us