SPROUT PHARMACEUTICALS, INC.: The Food and Drug Administration (FDA) Determines that Women Taking Addyi May Safely Consume Alcohol
Sprout continues to work with FDA to ensure other elements of labeling are in line with new study findings
Sprout continues to work with FDA to ensure other elements of labeling are in line with new study findings
BALVERSA is the first FGFR kinase inhibitor to receive U.S. FDA approval
Action completes a series of actions on the FDA’s review of OTC antiseptic active ingredients
The U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.
As part of the Trump Administration’s Winning on Reducing Food Waste Month, the U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) announced the release of a federal interagency strategy to address food waste.
The Food and Drug Administration (FDA) has given tentative approval for the generic version of Sernivo Spray 0.05% from Perrigo Company.
The U.S. Food and Drug Administration today approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture).
The U.S. Food and Drug Administration today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato.
The U.S Food and Drug Administration granted a De Novo review for a device intended to be used in the spine.
NanoViricides, Inc. (NYSE American: NNVC) (the "Company") a company with novel platform technology to treat difficult and life-threatening viral diseases, reports that US FDA has responded to its request for a pre-IND meeting.
Innoblative Designs, Inc. (Innoblative), a private medical device company committed to developing next generation, advanced-energy surgical solutions, announced it received U.S. Food and Drug Administration (FDA) clearance for its SIRA™ RFA Electrosurgical Device, a novel radiofrequency ablation (RFA) applicator that supplies energy for use in electrosurgery, specifically for intraoperative coagulation and ablation of soft tissue.
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
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.