Search Results for “FDA” – Page 55 – media

FDA Grants Breakthrough Therapy Designation to Pfizer’s Investigational Alzheimer’s Disease Treatment

Pfizer, a global pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational treatment for Alzheimer’s disease, called PF-05217917. This designation is intended to accelerate the development and review of promising drugs that have the potential to address serious or life-threatening conditions. Alzheimer’s disease is a progressive brain disorder that affects millions of people worldwide, causing memory loss and other cognitive impairments. There are currently no approved treatments that can slow or stop the progression of the disease. Pfizer’s PF-05217917 is an antibody that targets the tau protein, which is believed to play a key role in the development and progression of Alzheimer’s disease. The FDA’s decision to grant Breakthrough Therapy designation to PF-05217917 was based on the results of a Phase 2 clinical trial that involved patients with mild to moderate Alzheimer’s disease. The trial showed that ...
- Source: drugdu
- 238
- March 22, 2023
FDA Approves New Drug to Treat Migraine

The U.S. Food and Drug Administration (FDA) has approved a new drug, called Rizaport, for the treatment of acute migraine in adults. Rizaport is a fast-dissolving oral tablet that contains the active ingredient rizatriptan, which belongs to a class of drugs called triptans. Migraine is a neurological condition that affects approximately 39 million people in the United States. It is characterized by recurrent episodes of moderate to severe headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. Triptans are a commonly used class of drugs for the treatment of acute migraine, but they are not effective for all patients and may cause side effects such as dizziness and fatigue. Rizaport, developed by Intec Pharma, offers a new option for the treatment of acute migraine. It is designed to dissolve rapidly on the tongue, allowing for faster onset of action compared to traditional tablet formulations. In ...
- Source: drugdu
- 125
- March 22, 2023
Novartis Receives FDA Approval for New Heart Failure Drug

Novartis, a global pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for its new heart failure drug, called Entresto XR. This approval expands the use of the company’s existing heart failure drug, Entresto, by making it available in an extended-release form. Heart failure is a chronic condition in which the heart is unable to pump enough blood to meet the body’s needs. It affects millions of people worldwide and is a leading cause of hospitalization and death. Entresto XR is a once-daily tablet that combines two medications, sacubitril and valsartan, to reduce the strain on the heart and improve its ability to pump blood. The FDA’s approval of Entresto XR was based on the results of a clinical trial that involved over 5,000 patients with heart failure. The trial showed that Entresto XR was superior to the standard of care, enalapril, in ...
- Source: drugdu
- 247
- March 22, 2023
FDA Approves New Treatment for Rare Genetic Disorder

The U.S. Food and Drug Administration (FDA) has recently approved a new treatment for a rare genetic disorder called hereditary angioedema (HAE). The treatment, called Berinert, is manufactured by CSL Behring and is the first and only therapy approved for the treatment of acute attacks of HAE in pediatric patients. HAE is a rare genetic disorder that affects about 1 in 10,000 to 1 in 50,000 people worldwide. It is characterized by recurrent episodes of swelling, or edema, in various parts of the body including the hands, feet, face, and airways. These attacks can be severe and potentially life-threatening, especially when the swelling occurs in the airways, which can lead to difficulty breathing and asphyxiation. Berinert is a human plasma-derived C1 esterase inhibitor (C1-INH) that works by replacing the deficient or malfunctioning C1-INH protein in patients with HAE. The treatment is administered through intravenous infusion and can ...
- Source: drugdu
- 118
- March 22, 2023
US FDA approves Pfizer’s migraine nasal spray Zavzpret

Zavzpret’s approval expands Pfizer’s migraine portfolio that includes an oral therapy for acute and preventive treatment. The US Food and Drug Administration (FDA) has granted approval for Pfizer’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine. It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulations. The company stated that the regulatory approval expands its migraine portfolio, which includes oral therapy for acute and preventive treatment. Pfizer Global Biopharmaceuticals Business president and chief commercial officer Angela Hwang said: “The FDA approval of Zavzpret marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications. “Zavzpret underscores Pfizer’s commitment to delivering an additional treatment ...
- Source: drugdu
- 113
- March 16, 2023
FDA nod for Kiniksa’s Arcalyst in recurrent pericarditis

The US Food and Drug Administration (FDA) has approved Kiniksa Pharmaceuticals’ interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) inhibitor Arcalyst (rilonacept) for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. Recurrent pericarditis is an autoinflammatory cardiovascular disease that often presents with chest pain, and is associated with changes in electrical conduction and build-up of fluid around the heart. The FDA approval is based on positive data from the RHAPSODY trial in recurrent pericarditis. Data from this trial showed that Arcalyst treatment improved clinically meaningful outcomes associated with the significant unmet medical need in recurrent pericarditis. There were rapid and sustained reductions in both reported pain and inflammation as early as after the first dose of Arcalyst. “The approval of Arcalyst in recurrent pericarditis is an extremely important achievement for those suffering from this disease as there can be significant ...
- Source: drugdu
- 193
- March 23, 2021
Kiniksa
Albireo submits rare liver disease med odevixibat to FDA and EMA

Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). The US-based biopharmaceutical company has previously received fast track, rare paediatric disease and orphan drug designations for odevixibat in the US for PFIC. The drug also has orphan drug designations for the treatment for Alagille Syndrome, biliary atresia and primary biliary cholangitis. Odevixibat is a one-daily non-systemic ileal bile acid transport inhibitor (IBATi) currently being developed for the treatment of a number of rare paediatric liver diseases, such as PFIC, biliary atresia and Alagille syndrome. In a phase III trial evaluating the efficacy and safety of odevixibat in PFIC, the drug met two primary endpoints, demonstrating the ability to reduce serum bile acid responses and improve pruritus assessments with a single digit diarrhoea rate. “With randomised, placebo-controlled PEDFIC data, ...
- Source: drugdu
- 186
- March 5, 2021
Albireo Pharma
Ridgeback Biotherapeutics’ Ebola treatment scores FDA approval

Ridgeback Biotherapeutics’ Ebanga has been approved by the US Food and Drug Administration (FDA) for the treatment of Ebola in adult and paediatric patients. Ebanga (ansuvimab-zykl), formerly mAb114, is a monoclonal antibody isolated from a human survivor of the 1995 Ebola outbreak in Kikwit in the Democratic Republic of Congo (DRC). The development of the treatment has been funded in whole or in part with funds from the US Department of Health and Human Services, as well as the Office of the Assistant Secretary for Preparedness and Response and the Biomedical Advanced Research and Development Authority. The PALM study conclusively demonstrated Ebanga’s safety and efficacy in a randomised controlled trial conducted during the second largest and longest Ebola outbreak in DRC history. “The devoted Ridgeback team embarked on this mission with one goal in mind – to stop the spread of Ebola and stop the devastation created by this aggressive ...
- Source: drugdu
- 245
- December 24, 2020
Ridgeback Biotherapeutics
Albireo submits rare liver disease med odevixibat to FDA and EMA

Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). The US-based biopharmaceutical company has previously received fast track, rare paediatric disease and orphan drug designations for odevixibat in the US for PFIC. The drug also has orphan drug designations for the treatment for Alagille Syndrome, biliary atresia and primary biliary cholangitis. Odevixibat is a one-daily non-systemic ileal bile acid transport inhibitor (IBATi) currently being developed for the treatment of a number of rare paediatric liver diseases, such as PFIC, biliary atresia and Alagille syndrome. In a phase III trial evaluating the efficacy and safety of odevixibat in PFIC, the drug met two primary endpoints, demonstrating the ability to reduce serum bile acid responses and improve pruritus assessments with a single digit diarrhoea rate. “With randomised, placebo-controlled PEDFIC data, ...
- Source: drugdu
- 210
- December 13, 2020
Albireo
FDA authorises first home self-testing kit for COVID-19

RELATED TAGS: Lucira Health, Us, emergency use authorization, COVID-19 The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Lucira COVID-19 All-In-One Test Kit: the first COVID-19 diagnostic test for self-testing at home. Lucira says the kit takes around two minutes to use; and gives rapid results within 30 minutes. The $50 kit – which fits in the palm of the hand – provides a simple ‘positive’ or ‘negative’ reading. The kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. It is authorized for prescription home use with self-collected nasal swab samples in people aged 14+ who are suspected of having COVID-19 by a healthcare provider. “While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at ...
- Source: drugdu
- 340
- November 21, 2020
Covid-19

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