FDA

Pfizer-Biontech COVID-19 Vaccine Comirnaty Receives Full U.S FDA Approval.

August 23, 2021

British Reporter — According to Pfizer, COMIRNATY is the first COVID-19 vaccine to be granted FDA approval. Approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose. More than 1.2 billion Pfizer-BioNTech doses have been delivered to more than 120 countries or territories around the world since December 2020

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

The FINANCIAL -- While our efforts to combat COVID-19 remain at the forefront

by The FINANCIAL

December 25, 2020

2 mins read

FDA authorizes drug combination for coronavirus treatment

The FINANCIAL — The U.S. Food and Drug Administration issued an emergency use

by The FINANCIAL

November 20, 2020

3 mins read

Moderna coronavirus vaccine shows 94.5 % efficacy in Phase 3 trial

The FINANCIAL — Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics

by The FINANCIAL

November 16, 2020

3 mins read

Pharmacy

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

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

by The FINANCIAL

November 10, 2020

1 min read

Coronavirus

FDA authorizes monoclonal antibody for treatment of COVID-19

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

by The FINANCIAL

November 10, 2020

3 mins read

Pharmacy

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

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

by The FINANCIAL

November 6, 2020

1 min read

Tech

Abbott introduces 3D cardiac mapping platform in Europe and Australia

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

by The FINANCIAL

November 2, 2020

2 mins read

Coronavirus

First and only FDA-approved treatment of coronavirus

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

by The FINANCIAL

October 23, 2020

5 mins read

Pharmacy

FDA fully approved Venclexta combinations for acute myeloid leukaemia

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

by The FINANCIAL

October 19, 2020

2 mins read

Coronavirus

Roche to launch high-volume coronavirus antigen test

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

by The FINANCIAL

October 15, 2020

2 mins read

Pharmacy

AOA issues warning against illegally sold contact lenses

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

by The FINANCIAL

October 13, 2020

3 mins read

Coronavirus

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

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

by The FINANCIAL

October 9, 2020

3 mins read

WORLD

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

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

by The FINANCIAL

September 10, 2020

3 mins read