The approval is the first that the Food and Drug Administration has granted for a drug intended to treat eosinophilic esophagitis, a chronic immune disorder.
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
The agency has approved an expanded indication for Qelbree extended-release capsules to treat attention deficit hyperactivity disorder in younger patients.
The US agency has expanded its approval of Veklury to include use in pediatric patients 28 days and older who have tested positive for the COVID-19 virus.
The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.
A renowned university researcher explains the path that laid the foundation and what the novel diagnostic and treatment means for prostate cancer patients.
The agency has approved Lynparza for use in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.
The two companies are collaborating on development of Myfembree, a combination therapy to treat the painful condition affecting millions of women worldwide.
The US agency continues to oversee vaccine and drug development, and to share information and advice for life-sciences professionals and civilians alike.
Nucala, a monoclonal antibody indicated for patients with chronic rhinosinusitis with nasal polyps, has been approved by the Food and Drug Administration.
The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.
The company’s cancer drug, devimistat, has received orphan status from the agency for treating clear-cell sarcoma, pancreatic cancer, and other diseases.
Mylan and Micro Labs receive US FDA approval for two generic versions of Pfizer and BMS’ Eliquis, marking the first generic approvals of direct oral anticoagulants.
Recro Pharma announces the separation of its acute care business to launch Baudax Bio as a developer of products, including non-opioid analgesics, to concentrate on its CDMO business.
US FDA approves Fetroja, an antibiotic developed by Shionogi, for the treatment of complicated urinary tract infections, as part of the effort to fight AMR.
US FDA approves Noven’s schizophrenia treatment administered through a once-daily transdermal delivery system, able to release the antipsychotic drug for 24 hours.
Celgene’s Inrebic becomes the first treatment for myelofibrosis to be approved by the US FDA since 2011 after having received a priority review and orphan drug designation.
Rinvoq from AbbVie to be available in the US in late August 2019, after receiving FDA approval for the treatment of adults with active rheumatoid arthritis.
FDA approves the third anti-TB drug in more than 40 years after the compound showed significantly higher success rates in patients with multi drug-resistant and extensively drug-resistant TB.
The FDA approved Teva's generic for Sabril, the first generic for the drug, as the agency continues to focus its efforts to approve generics that face little competition.
President Donald Trump signed the SUPPORT act granting the FDA additional authority to combat the opioid epidemic, but a pain management CRO argues that opioid addiction isn’t the only crisis.
Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.
The price of running a clinical trial to obtain FDA approval is a fraction of the total drug development cost – challenging traditionally held beliefs about the amount of money required to study prescription drugs, according to new research.
