COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs
FDA is committed to transparency around the EUA process
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FDA is committed to transparency around the EUA process
FDA approved the antiviral drug Veklury (remdesivir) for adults and pediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalization. Veklury is the first treatment for COVID-19 to receive FDA approval.
FDA is warning about a potential drug interaction with remdesivir, which received emergency use authorization to treat hospitalized COVID-19 patients with severe disease.
FDA has issued emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
Effective management of hypertensive disorders of pregnancy is critical to reducing maternal morbidity, improving fetal outcomes, and mitigating long-term cardiovascular risk. This review provides a practical framework for antihypertensive medication selection in pregnancy and the postpartum period.
Myricx Bio brings to Novartis antibody drug conjugates with a novel cancer-killing payload called an NMT inhibitor. Novartis says Myricx’s drugs could have advantages over currently available ADCs as well as those still in clinical development. The post A $1B Acquisition Gives Novartis a Way to Stand Out in Crowded Area of Cancer appeared first on MedCity News .
Homeopathic products are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. Learn more.
FDA recognizes that patients affected by coronavirus 2019 (COVID-19) are in great need of medicines to treat this disease. To help meet this need, the agency is helping to speed the development of promising therapies through its Coronavirus Treatment Acceleration Program (CTAP).
FDA has a critical role in ensuring the safety of patients in clinical trials studying drugs for the prevention or treatment of COVID-19 that require an investigational new drug (IND) application.
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
FDA authorizes Gohibic (vilobelimab) injection
Fayus Inc., doing business as Yusol International Foods (Sacramento, CA) is voluntarily recalling OLA-OLA POUNDED YAM because the product may contain undeclared milk in the form of sodium caseinate, which is not declared on the label.
Fayus Inc., doing business as Yusol International Foods (Sacramento, CA) is voluntarily recalling OLA-OLA POUNDED YAM because the product may contain undeclared milk in the form of sodium caseinate, which is not declared on the label.
Aging is a major risk factor for most diseases, and accelerated biological aging is increasingly recognized in many chronic diseases. Chronological age refers to the time that has elapsed since birth, whereas biological age reflects functional, cellular, and tissue age.
Guidance on the process for ending a clinical trial.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Tables showing confirmed toxigenic C. diphtheriae cases among asylum seekers in England between 2022 and 2026.
Boston Scientific, Medtronic and Stryker were among the companies to ink deals to move into markets that are expanding quickly.
by Jin Ding, Michael M. Hopkins, Paul A. Martin Background The United States (US) and European Union (EU) have long-established orphan drug regulations to incentivise the development of medicines for rare diseases. While the numbers of orphan approvals have risen rapidly, there is increasing discordance in regulatory outcomes between the US and EU. This discordance primarily stems from two sets of cases: US Food and Drug Administration (FDA) orphan approvals not authorised by the European Medicines Agency (EMA), and FDA orphan approvals with EMA authorisation but without orphan designation. We…
Healthcare does not lack the data needed to better understand oncology costs. What it does lack is a consistent way to connect clinical progression with financial impact in a time frame that aligns with strategic planning. The post In Oncology, the Cost Problem Goes Beyond Predictability appeared first on MedCity News .
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This webpage provides links to certain publicly available external reports and resources relating to patient experience data. The patient community, patient advocates, researchers, drug developers, and federal agencies may find these materials useful.
The existing yellow heat-health alert for the East Midlands, West Midlands, East of England, London, South East and South West will be escalated to amber
The rule, released Thursday, builds on Trump administration priorities, including cutting Medicare reimbursement for drugs in the controversial 340B program and equalizing payment between sites of care.