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The U.S. Food and Drug Administration issued a warning letter to Inova Genomics Laboratory (Inova) of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness.
LSK BioPharma (or "LSKB"), a US-based biopharmaceutical firm and Jiangsu Hengrui Medicine, Co., Ltd. (SHA:600276, or "Hengrui"), one of the largest and most innovative fully-integrated biopharmaceutical companies based in China, announced that the Companies have received FDA clearance to initiate a clinical trial in the United States in first-line patients with advanced hepatocellular carcinoma (HCC), evaluating the safety and efficacy of LSKB's rivoceranib, a selective VEGFR-2 inhibitor commonly known as apatinib, in combination with Hengrui's camrelizumab (SHR-1210), a humanized anti-PD-1 monoclonal antibody currently under NDA review in China for classic Hodgkin's Lymphoma (cHL).
The U.S. Food and Drug Administration today is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.
The U.S. Food and Drug Administration and the U.S. Customs and Border Protection (CBP) leaders signed an agreement today to maximize inspection and detection capabilities in order to prevent illegal and harmful products entering the U.S. through the nation’s International Mail Facilities (IMFs) and Ports of Entry that pose a threat to public health
Eleven drugs were recalled in March to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
CSA Medical today announced that its RejuvenAir® System has been designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA) and received unconditional IDE (Investigational Device Exemption) approval to initiate a pivotal clinical study to treat patients with moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis (CB). The RejuvenAir® System utilizes a Metered Cryospray of liquid nitrogen at -196◦C to targeted areas within the lungs.
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) of quizartinib, an investigational FLT3 inhibitor, currently under Priority Review for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML).
The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) kick off Winning on Reducing Food Waste Month by calling for greater collaboration with public, private, and nonprofit partners as well as state and local officials to educate and engage consumers and stakeholders throughout the supply chain on the need to reduce food loss and waste.
The U.S. Food and Drug Administration announced the issuance of two warning letters to operators of websites that illegally market potentially dangerous, unapproved and misbranded opioid medications, including tramadol.
The U.S. Food and Drug Administration today posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C.
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The U.S. Food and Drug Administration today approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease
The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation.
A new treatment for anxiety, depression and insomnia may be on the way now that Innovative Neurological Devices received FDA market clearance for its Cervella Cranial Electrotherapy Stimulator (CES).
The Europa Pedicle Screw System received FDA 510(k) approval at the end of March.
Luye Pharma Group has announced submission of a new drug application (NDA) to the U.S. Food and Drug Administration ("FDA") for Rykindo®, completed on March 28. Rykindo® (LY03004) Risperidone Extended-release Microsphere for Injection is expected to become the first Chinese innovative drug to receive U.S. FDA approval for marketing in the United States.
Patients living with non-radiographic axial spondyloarthritis, an often undiagnosed, chronic, painful and debilitating disease, now have an approved, clinically validated treatment
Novel, effective endobronchial valve treatment now used by physician at hospital in Philadelphia
MAVENCLAD is the first oral MS treatment to provide two years of proven efficacy with a maximum of 20 days of treatment
Twelve prescription drugs were recalled in January and February to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
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If approved, INVOKANA® will be the first and only therapy in nearly 20 years indicated to reduce the risk of end-stage kidney disease when added to current standard of care