The U.S. Food and Drug Administration today approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults.
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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.
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 (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.
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.
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).
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).
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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
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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Emflaza is the only approved treatment for all patients two and over living with Duchenne muscular dystrophy
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.
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.
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.
Orion Biotechnology Canada Ltd., announced that it has received feedback from the Food and Drug Administration (FDA) on a Pre-Investigational New Drug (PIND) application which was submitted in March 2019.
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Pilot looks to implement tech that improves the tracking of powerful drugs and interoperability of software throughout the supply chain
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New diagnostic test enables antibiotic resistance testing and stewardship in gonorrhea treatment
A public health watch dog warns that the presence of “forever chemicals” in foods recently tested by the Food and Drug Administration should be treated with alarm.
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Applied BioCode announced that it has received U.S. Food and Drug Administration 510(k) clearance for the use of the Roche MagNA Pure 96* Extraction System with the high throughput BioCode® MDx-3000 and Gastrointestinal Pathogen Panel (GPP).
Bolder BioTechnology, Inc. announced that its long-acting IL-11 analog, BBT-059, has received Orphan Drug designation from the Food and Drug Administration for treatment of Acute Radiation Syndrome (ARS).
In-silico bioequivalence approach using Simcyp’s Multi-Phase Multi-Layer Mechanistic Dermal Absorption model successfully replaced in-vivo, clinical studies in FDA AND