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food and drug administration

FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs

4 mins read

The FINANCIAL -- While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.…

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FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs

4 mins read

The FINANCIAL -- While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact…

Merck Announces Supply Agreement with U.S. Government for Initial Doses of Investigational Biological Therapy for the Treatment of Patients with Severe and Critical COVID-19

3 mins read

The FINANCIAL -- Merck known as MSD outside the United States and Canada, today announced it has entered into an agreement with the United States Government to support the development, manufacture and initial distribution of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon approval or Emergency Use Authorization (EUA) from the U.S. Food and…

FDA authorizes monoclonal antibody for treatment of COVID-19

7 mins read

The FINANCIAL —  The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least…

Nestle to buy Aimmune’s peanut allergy treatment at $2.6 billion

6 mins read

The FINANCIAL — Nestle agreed to buy Aimmune Therapeutics Inc. for $2.6 billion, adding a promising peanut allergy treatment to its portfolio of coffee, snacks and water. The Swiss owner of Nespresso will pay $34.50 a share for the U.S. biotech firm, almost triple its last closing price. Aimmune makes a therapy to help reduce allergic…

FDA recalled more than 75 toxic hand sanitizers

7 mins read

The FDA increased the list of toxic hand sanitizers. Earlier this month, FDA has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested. FDA…

FDA warns about toxic hand sanitizers

5 mins read

The FINANCIAL — FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through…