Tag: FDA

May 26, 2023

The designations for the investigational oral factor XIa inhibitor cover all three indication-seeking studies within the phase 3 Librexia development programme: ischaemic stroke, acute coronary syndrome and atrial fibrillation. According to the companies, the programme aims to evaluate whether milvexian […]

May 26, 2023

Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. […]

May 25, 2023

AbbVie announced on May 19, 2023 that FDA has approved EPKINLY (epcoritamab-bysp), a T-cell engaging bispecific antibody for treating relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The bispecific is particularly indicated for treating adult patients with R/R DLBCL, […]

May 25, 2023

Americans with COVID-19 have been taking Paxlovid since it was approved under emergency use in late 2021. Today, the U.S. Food and Drug Administration granted full approval to the drug. This approval will allow drugmaker Pfizer to sell the medication […]

May 24, 2023

Acinetobacter baumannii are a common cause of pneumonia in hospitals, and infections can be life-threatening. Innoviva’s treatment consists of a drug, sulbactam, that’s similarly structured as the antibiotic penicillin, along with another compound, durlobactam, that helps protect it from degradation. […]

May 24, 2023

The Food and Drug Administration has delayed its review of a closely watched gene therapy for Duchenne muscular dystrophy by one month, taking more time to consider whether approval should be initially limited to children who are most likely to […]

May 23, 2023

The Vaccines and Related Biological Products advisory committee (VRBPAC) voted unanimously that the available data supported the efficacy of RSVpreF in helping to protect against the complications of RSV in infants from birth to six months of age. The committee […]

May 23, 2023

The launch of Ayvakit in indolent systemic mastocytosis, or ISM, is being closely watched by investors and analysts. Blueprint brought two drugs to market in recent years — Ayvakit and the cancer drug Gavreto — and since expanded use of […]

May 19, 2023

The vaccine, if approved, would be the first available for protecting infants from a pathogen that each year kills hundreds of young children. It is one of a recent wave of drugmaker successes against the disease after decades of effort. […]

May 19, 2023

Patients with Crohn’s disease have a new treatment option, following U.S. Food and Drug Administration approval of a pill called Rinvoq (upadacitinib). Rinvoq is meant to treat adults with moderately to severely active Crohn’s disease who have not had success […]

May 18, 2023

While the world may have marched on from the halcyon days of the mid-20th century where the United States was the undisputed center of the global economy, the country’s continual impact should not be understated. Particularly as it concerns the […]

May 18, 2023

The first vaccine designed to protect infants against respiratory syncytial virus (RSV) by vaccinating their mothers during pregnancy has been backed by a panel of advisers to the U.S. Food and Drug Administration. On Thursday the independent committee of experts […]

May 17, 2023

Food and Drug Administration scientists reviewing what could become the first medicine for the fatty liver disease NASH are skeptical the treatment’s safety risks outweigh its “modest” benefits, according to documents made public Wednesday. The documents were posted online ahead […]

May 16, 2023

Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF). This news […]

May 15, 2023

The U.S. Food and Drug Administration on Friday approved the first nonhormonal medication aimed at easing menopause hot flashes. The new pill, called Veozah (fezolinetant), is a neurokinin 3 (NK3) receptor antagonist. “It works by binding to and blocking the […]

May 12, 2023

Outside advisors for the U.S. Food and Drug Administration voted Thursday to recommend approval of Neffy, the first epinephrine nasal spray for severe allergic reactions. Although most of the Pulmonary-Allergy Drugs Advisory Committee members supported the spray for adults (16:6) […]

May 12, 2023

A group of Food and Drug Administration advisers narrowly supported approving what could be the first gene therapy for Duchenne muscular dystrophy in a meeting Friday, clearing the way for the agency to make a closely watched decision later this […]

May 11, 2023

Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication. “Agitation […]

May 10, 2023

FDA announced the approval of GSK’s Biologicals’ Arexvy, a respiratory syncytial virus (RSV) vaccine, on May 3, 2023. The vaccine is the first to be approved for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged […]

May 10, 2023

Food and Drug Administration scientists evaluating what could be the first gene therapy for Duchenne muscular dystrophy appear skeptical of the treatment’s benefit, adding to questions about its approval prospects days before a crucial regulatory meeting. On Friday, the FDA […]