The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs).
The U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH).
Acceptance marks critical milestone in Biohaven's efforts to develop NURTEC ODT as a unique dual therapy for both the preventive and acute treatment of migraine
Tevogen Bio, today announced that its Investigational New Drug (IND) application to develop a COVID-19 treatment using proprietary antigen specific T cell technology has been submitted to the US Food and Drug Administration (FDA).
Subsequent clinical trials expected to commence in 2020
U.S. Prescribing Information (USPI) updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly topical treatment with Enstilar® (calcipotriene and betamethasone dipropionate) Foam in adults with plaque psoriasis
Avioq, Inc. announces it has received approval from the U.S. Food and Drug Administration (FDA) for their VioOne™ HIV Profile™ Supplemental Assay.
Detection of genomic alterations that drive the growth and spread of the tumor can guide treatment decisions for cancer therapies, including available biomarker driven treatments
EpiVax and CUBRC announce $1.1M contract award from the OGD in CDER of the FDA in response to FDA BAA-20-00123.
Embody, Inc., a privately-held medical device company developing novel collagen-based technologies for sports medicine and soft tissue repair, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TAPESTRY Biointegrative Implant for tendon and ligament repair.
U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.
In Phase 2b development for the treatment of life-threatening fungal infections
In three pivotal Phase 3 studies, RINVOQ met co-primary and all secondary endpoints in adult and adolescent patients with moderate to severe atopic dermatitis
Neurelis, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company's lead product, VALTOCO® (diazepam nasal spray).
The MOU will maximize inspection and detection capabilities in order to prevent this illegal activity.
As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency.
Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. FDA Under Emergency Use Authorization
Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on ophthalmology, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for cyclosporine topical ophthalmic emulsion, 0.1% for the treatment of severe vernal keratoconjunctivitis (VKC) in patients ages 4-18.
Application seeks approval of XARELTO® plus aspirin to reduce the risk of major thrombotic vascular events in patients after lower-extremity revascularization due to symptomatic peripheral artery disease (PAD)
Abre™ Venous Self-Expanding Stent System Safe, Effective in Treating Challenging Deep Venous Lesions