The U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as “BR”), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.
Five drugs were recalled in May to protect patients from possible harmful defects associated with the products, the U.S. Food and Drug Administration reported.
Vivacelle Bio, Inc. announced that it supported an investigational new drug (IND) application to the U.S. Food & Drug Administration for a phase IIa clinical trial of VBI-S, a phospholipid-based nanoparticle fluid that has the potential to elevate the blood pressure of patients who are suffering severe septic shock.
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Emflaza is the only approved treatment for all patients two and over living with Duchenne muscular dystrophy
The Food and Drug Administration's (FDA) recently announced a mandatory added sugar labeling policy for packaged foods and beverages, set to take effect between 2020 and 2021.
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With this approval, Emgality is the only calcitonin gene-related peptide (CGRP) antibody indicated for the preventive treatment of migraine and the treatment of episodic cluster headache
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Biosight Ltd., a pharmaceutical development company focused on the development of novel oncology therapeutics, announced today that the United States Food & Drug Administration (FDA) has granted Orphan Drug Designation to BST-236, an investigational novel antimetabolite, for the treatment of acute myeloid leukemia (AML).
A five-year base contract worth an estimated $100 million between Learning Tree International and Suntiva will help support the Food and Drug Administration (FDA) Integrated Services Blanket Purchase Agreement (BPA).
Curio Wellness, the market-leading medicinal cannabis company in Maryland, presented a scientifically grounded, patient-focused perspective to de-schedule cannabis and have it regulated under the Food and Drug Administration’s Federal Food, Drug, and Costmetic Act.
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 is warning consumers about safety concerns regarding an ingredient called vinpocetine that is found in dietary supplements, specifically concerns about the use of this ingredient by women of childbearing age.
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The U.S. Food and Drug Administration Oncology Center of Excellence announced a new pilot program to assist oncology health care professionals in requesting access to unapproved therapies for patients with cancer.
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.
Cadent Therapeutics, a company focused on the development of therapies to improve the lives of patients with movement and cognitive disorders, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAD-1883, an investigational treatment for spinocerebellar ataxia (SCA), a genetic disorder characterized by progressive loss of coordination, slurred speech, difficulty controlling eye movements and cognitive dysfunction.
Improved accuracy in identifying bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis, CV) and trichomoniasis (Trichomonas vaginalis, TV) will enable more targeted treatment for women
