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FDA

Pfizer Vaccine Could Gain Full FDA Approval Within Weeks

3 mins read

The FINANCIAL —  The New York Times reports that the unofficial internal deadline at the Food and Drug Administration is Labor Day or earlier. And a new survey finds that more than half of unvaccinated people still think the shot is riskier than covid, Kaiser Family Foundation notes.…

FDA Announces New Actions Aimed at Further Reducing Toxic Elements in Food for Babies, Young Children

9 mins read

The FINANCIAL -- The U.S. Food and Drug Administration takes exposure to toxic elements, such as arsenic, mercury, cadmium and lead, in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. That is why today, we are announcing new actions…

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…

FDA authorizes drug combination for coronavirus treatment

7 mins read

The FINANCIAL — The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a…

Moderna coronavirus vaccine shows 94.5 % efficacy in Phase 3 trial

7 mins read

The FINANCIAL — Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria…

Bayer submits marketing authorization applications for finerenone in the U.S. and the EU

2 mins read

The FINANCIAL — Bayer announced the submission of regulatory applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) seeking approval of finerenone for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone is a first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that demonstrated renal 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…

FDA approved AstraZeneca’s Brilinta to reduce the risk of stroke

3 mins read

The FINANCIAL — AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke (National Institutes of Health Stroke Scale score ≤5) or high-risk transient ischaemic attack (TIA). The approval by the US Food and Drug Administration (FDA) was based…

Abbott introduces 3D cardiac mapping platform in Europe and Australia

4 mins read

The FINANCIAL — Abbott today announced it has received CE Mark and approval in Australia for its new EnSite™ X EP System, and is launching the system throughout Europe and Australia. The EnSite X System is the only system that offers the option to navigate the cardiac anatomy two different ways on one platform. Abbott sought…

First and only FDA-approved treatment of coronavirus

12 mins read

The FINANCIAL — Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury® (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Previously authorized by the FDA for emergency…

FDA fully approved Venclexta combinations for acute myeloid leukaemia

5 mins read

The FINANCIAL — Roche today announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive…

Roche to launch high-volume coronavirus antigen test

5 mins read

THe FINANCIAL — Roche announced that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for…

AOA issues warning against illegally sold contact lenses

6 mins read

The FINANCIAL — Insecure, illicit, infectious—three I’s no one wants near their eyes, which is why the AOA is issuing a Halloween warning against illegally sold contact lenses and urging doctors to report such retailers. As Americans still grapple with an ongoing COVID-19 public health emergency that has prompted calls to cancel large social gatherings and…

Abbott releases interim clinical study results on COVID-19 PCR tests

7 mins read

The FINANCIAL — In a continuing effort to provide the facts about ID NOW to support public health interests, Abbott (NYSE: ABT) is sharing new interim clinical data results on its ID NOW COVID-19 rapid test. The results confirm the data submitted to the U.S. Food and Drug Administration (FDA) in March for Emergency Use Authorization…

U.S. teen vaping rates drop by almost 2 mln

7 mins read

The FINANCIAL — Almost 2 million fewer U.S. teenagers reported using e-cigarettes in 2020 compared to 2019, according to new data from the U.S. Centers for Disease Control and Prevention. Around 3.6 million young people in the US were current (in the past thirty days) e-cigarette users in 2020, down from 5.4 million in 2019. Just…