drug approval News
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FDA consumer health information - generic drug roundup: December 2010
Each year, the Food and Drug Administration (FDA) approves many generic drugs that treat a wide variety of conditions and help consumers save money. To read about recent significant FDA approvals for generic medications, go to http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm236544.htm. Sign up for e-mail notices of new FDA Consumer Updates at: ...
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FDA and Health Canada Approve Thermedical’s Degassed Salineto Help Reduce Risk of Stroke
MONTREAL and WALTHAM, Mass., June16, 2020–The Montreal Heart Institute(MHI) and Thermedical®, a developer of thermal-ablation systemsto treat ventricular arrhythmias, today announced the first ablation performed using the groundbreaking Durablate® retractable needle catheter and degassed saline, which together eliminateover98% of the air bubbles that can lead to stroke. Health ...
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Notitia Biotechnologies receives approval from FDA for phase 2A clinical trial in diabetic & prediabetic patients
Notitia Biotechnologies Company has received the Investigational New Drug (IND) approval from the FDA for NBT-NM108, a proprietary formula designed to support the Foundation Guild bacteria in the patient's gut microbiome. The FDA has allowed Notitia to test the drug as a treatment for COVID-19 in patients with type 2 diabetes and prediabetes. Notitia has secured funding for a Phase 2a ...
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Online Sales of Prescription Drugs via Donation
Many public services, e.g. the public school system, make up resource deficits by soliciting or accepting private charitable donations. This strategy does not work for prescription drug donations as they require a medical order for sale to a private customer; a prospective donor can’t simply walk into Walgreens and buy epinephrine, heparin, insulin, Zofran, Dilaudid or ketamine. Emergency ...
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Novartis PluvictoTM approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer
Basel, March 23, 2022 — Novartis announced today that the US Food and Drug Administration (FDA) approved PluvictoTM (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castrationresistant prostate cancer (PSMA-positive ...
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4 Drug-Free Tips to Outsmart a Migraine this 4th of July
Cefaly® the first device of its kind to receive U.S. Food and Drug Administration (FDA) approval for the preventive treatment of migraine headaches wants all migraineurs to enjoy a safe, and migraine-free, 4th of July. “A terrible migraine can dampen any holiday,” says Dr. Mark Harman, US Medical Director with CEFALY Technology. “We’d like any fogginess this ...
By CEFALY
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Showcase
New device offers a mouthful of data for chronic diseases
Aidar Health, formerly known as Multisensor Diagnostics, has developed a portable hand-held device that allows patients to measure and track vital signs in a matter of seconds. Roughly the size of an iPhone, MouthLab consists of a hand unit and a mouthpiece that fits between the teeth and lips. The mouthpiece uses special sensors to gather information from breathing patterns, saliva and blood ...
By Aidar Health
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Kala Announces Entry into Definitive Agreement to Sell EYSUVIS® and INVELTYS® to Alcon Inc.
ARLINGTON, Mass., May 23, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has entered into a definitive agreement to sell its commercial portfolio and related intellectual property assets to Alcon Inc. ...
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Oral Presentation on Antengene`s Anti-CD24 Monoclonal Antibody ATG-031 Selected for SITC`s Top 100 Abstracts
Antengene is proud to announce that the oral presentation for ATG-031 (anti-CD24 monoclonal antibody) presented at the 37th Society for Immunotherapy of Cancer Annual Meeting (SITC 2022) was selected for the SITC top 100 abstracts. ATG-031 is a first-in-class, humanized anti-CD24 antibody. ATG-031 potently binds to CD24-postive tumor cells. ATG-031 blocks the interaction between CD24 and ...
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Healx receives IND and Orphan Drug Designation for fragile X clinical trial
Healx has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for the Phase 2a clinical study of the compound HLX-0201 for Fragile X syndrome. The clinical study will attempt to find at least one novel and effective combination therapy for Fragile X syndrome - the world’s leading inherited cause of autism and learning difficulties which affects ...
By Healx Ltd.
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Newly founded research group uses AP-MS to reveal drug targets for Covid-19
QCRG, a newly formed research team, is a collaborative effort between 22 research labs from the University of California, San Francisco, consisting of researchers investigating Covid-19. In a recent proteomics study, the team used affinity purification–mass spectrometry (AP-MS) to uncover new insights into effective molecular targeting. Covid-19 Covid-19 is a respiratory disease caused by ...
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LISCure Biosciences Announces Research Collaboration with The Scripps Research Institute for Immuno-Oncology
LISCure Biosciences ("LISCure") announced that it had reached an agreement with The Scripps Research Institute ("Scripps Research") to collaboratively research on bacteria-mediated immuno-oncology candidates against multiple cancer types. Scripps Research is the top nonprofit scientific institute in the US for producing high-quality research based on discoveries published in leading scientific ...
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Billix, 14 billion Series A round closing
Billix has successfully completed the Series A round. It raised 14 billion won in an investment round in a year and a half. Not only financial investors (FI) but also strategic investors (SI) such as Estec Pharma and Soulbrain Holdings continued to participate. According to related industries on the 25th, Bilix recently completed attracting 14 billion won in Series A investment. As a result, the ...
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MerLion Pharmaceuticals Completes Growth Financing Round
MerLion Pharmaceuticals GmbH (MerLion), a biopharmaceutical company focused on research and development of novel antibiotics for the treatment of serious bacterial infections, today announced the successful completion of a growth financing round raised via a private placement to European strategic investors. The funds raised will primarily be used to finance the production and market launch of ...
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AVRA Medical Robotics Initiates Food and Drug Administration Approval Process
ORLANDO, Fla., Aug. 28, 2019 (GLOBE NEWSWIRE) — AVRA Medical Robotics, Inc. (the “Company”) (OTCQB: AVMR), an emerging growth company that is in the process of building a fully autonomous medical robotic system through the use of new technologies combining artificial intelligence, machine learning and proprietary software; announced today that its regulatory and management teams ...
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ConsortiEX has first live Dynamic Patient Specific Compounding Customer
Since our foundation, ConsortiEX has aimed to deliver highly innovative IT systems for hospitals and their affiliated networks. A crucial part of that goal was a seamlessly integrated solution that would satisfy the need for both anticipatory batch and patient specific compounding. We have achieved this with our Assure-Trak® IV Workflow Management application for both Batch and Dynamic ...
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Pascal Biosciences First to File Patent for COVID-19 Antiviral Activity with CBD
VANCOUVER, BRITISH COLUMBIA, April 21, 2022- Pascal Biosciences Inc. (“Pascal” or the “Company”) (TSXV:PAS) (OTC:PSCBF) (FSE: 6PB-FF) was the first to report cannabinoids can kill SARS-CoV-2, the virus that causes Covid-19. Pascal filed an international patent covering this work prior to the press release in July 2020, and now it is clear that Pascal was the first to file ...
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AOBiome Featured in Bloomberg Businessweek
It was a snowy week in February 2009 when David Whitlock packed up his three-bedroom apartment near Cambridge, Mass., and moved into his van. Then 54 years old, the inventor had spent all his money, almost half a million dollars, on worldwide patent filings for a newfound obsession: a type of bacteria, culled from soil samples, that he theorized would improve skin disorders, hypertension, and ...
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Aptorum Group Limited Interview to Air on Bloomberg U.S. on the RedChip Money Report®
April 22, 2022 at 8:00 AM EDT NEW YORK & LONDON & PARIS--(BUSINESS WIRE)--Apr. 22, 2022-- Regulatory News: Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) (“Aptorum Group” or “Aptorum”), a clinical-stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology and infectious diseases, today announced that an interview with ...
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Vaccitech Appoints Two Independent Board Directors
Vaccitech Ltd., a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer, today announced the appointment of two new independent directors to its Board of Directors. Dr. Anne Phillips, FRCPC, and Karen A. Dawes, MBA, joined the Board on 17 February 2021. Their ...
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