Tag Archives: FDA

On Friday, the Food and Drug Administration (FDA) revealed its approval of Pfizer’s treatment for a rare genetic bleeding disorder, marking the company’s debut gene therapy to receive clearance in the U.S. Marketed under the name Beqvez, the drug has been given the green light by the agency for adults ...

On Thursday, the Food and Drug Administration granted approval for the inaugural treatment targeting a prevalent and potentially fatal liver condition impacting millions globally. This landmark decision signifies a significant breakthrough for Madrigal Pharmaceuticals, distinguishing it from numerous larger competitors who have struggled or are still striving to penetrate this ...

On Monday, the Food and Drug Administration (FDA) gave its nod to a vaccine developed by Pfizer, designed to safeguard infants against respiratory syncytial virus (RSV), which stands as the primary cause of hospitalizations among infants in the United States. This move follows the prior approval and availability of Pfizer’s ...

The U.S. Food and Drug Administration granted approval to Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as supplementary treatments to diet and exercise. These medications aim to enhance blood sugar control in children aged 10 years and above who are diagnosed with type 2 diabetes. This recent approval signifies ...

The FDA has granted approval for Veozah (fezolinetant), an oral medication designed to treat moderate to severe vasomotor symptoms, including hot flashes, associated with menopause. This marks the first FDA-approved neurokinin 3 (NK3) receptor antagonist for treating hot flashes caused by menopause. Veozah functions by binding to and inhibiting the ...

The U.S. Food and Drug Administration has modified the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines, making the vaccination schedule simpler for most people. The revised EUAs authorize the use of the current bivalent vaccines (original and omicron BA.4/BA.5 strains) for all doses given ...

The U.S. Food and Drug Administration declared on Tuesday that individuals who are seniors or have compromised immune systems can receive an additional dose of the bivalent COVID-19 vaccine during this spring. According to the FDA, individuals who are 65 years and older can receive a booster shot of the ...

Boehringer Ingelheim announced on Sep 1 that the U.S. Food and Drug Administration (FDA) has approved Spevigo for the treatment of generalized pustular psoriasis (GPP) in adults. it is the first approved treatment option for generalized pustular psoriasis in adults. Spevigo is a new, selective antibody that inhibits the activation ...

The first full approval of a drug has been given by the US Food and Drug Administration to treat lymphoma in dogs. The FDA has fully approved Tanovia (rabacfosadine injection) for the treatment of lymphoma in dogs. Lymphoma, also known as lymphosarcoma, is a type of cancer that can affect ...

The United States Food and Drug Administration (FDA) has approved the Kerendia (finerenone) for the treatment of chronic kidney disease patients associated with type 2 diabetes. Bayer announced that the US Food and Drug Administration (FDA) has approved Kerendia (finerenone) tablets to reduce the risk of decline in kidney function, ...