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The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
Nouscom, an immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, announced that its Investigational New Drug (IND) application for the first clinical trial of its lead candidate NOUS-209 has been cleared by the US Food and Drug Administration (FDA).
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The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older.
The U.S. Food and Drug Administration today approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults.
The U.S. Food and Drug Administration recently approved a drug that costs $2.1 million and it’s a potential cure for a childhood disorder that afflicts children under 2 years of age.
The Food and Drug Administration granted full approval to nearly 800 generic drugs in fiscal year 2018, a 90 percent increase over the same time period four years ago, according to a recent analysis by PricewaterhouseCoopers LLP.
Improved accuracy in identifying bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis, CV) and trichomoniasis (Trichomonas vaginalis, TV) will enable more targeted treatment for women
The ZIKV Detect 2.0 IgM Capture ELISA has been authorized for marketing by the Food and Drug Administration for detection of Zika virus immunoglobulin.
U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Aliqopa based on follow-up data from the pivotal Phase II CHRONOS-1 study
Expects Enrollment of Phase I Trial to Begin in the Third Quarter of 2019
True Diagnostics, Inc. (True), a leading company for Point of Care Answers, announced that its VeriClear™ Digital Early Result Pregnancy Test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for detecting human chorionic gonadotropin (hCG) levels in women prior to their first missed period.
New Indication Makes VRAYLAR First and Only Dopamine and Serotonin Partial Agonist to Treat the Full Spectrum of Bipolar I Symptoms in Manic, Mixed, and Depressive Episodes
SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis and, when left untreated in its most severe form, permanent ventilation or death for most patients by age 2[1,2]
The U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.
Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved SORILUX® (calcipotriene) Foam, 0.005% in adolescents.
An anticoagulant injection, Fragmin, was approved by the Food and Drug Administration last week for pediatric patients.