Search Results for “FDA” – Page 43 – media

FDA approves second over-the-counter naloxone nasal spray for opioid overdose

The US Food and Drug Administration (FDA) has approved the over-the-counter (OTC), non-prescription use of Harm Reduction Therapeutics’s RiVive, a 3mg naloxone hydrochloride nasal spray, for the emergency treatment of known or suspected opioid overdose. The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved. FDA commissioner, Robert Califf, said: “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. “Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health.” Prescription opioids, such as morphine, codeine and fentanyl, are used as treatments to relax the body and relieve pain. However, misuse of opioids can lead to several harmful effects, including slowed breathing, and hypoxia, which can ultimately lead to death. In the US, drug ...
- Source: drugdu
- 104
- August 2, 2023
FDA Adopts New Sterilization Standard to Support Switch From Ethylene Oxide

Dive Brief The U.S. Food and Drug Administration has adopted an international sterilization standard to give medical device manufacturers another alternative to ethylene oxide (EtO). Manufacturers can now make declarations of conformity to the International Organization for Standardization’s recommendations on low-temperature vaporized hydrogen peroxide in submissions to the FDA. The FDA framed the addition of the ISO test to its Recognized Consensus Standards database as a response to pressure to reduce EtO use and the need to support supply chain resiliency. Dive Insight In April, the U.S. Environmental Protection Agency proposed limiting EtO emissions from sterilization facilities by 80% to minimize the risk of people developing cancer from exposure to the gas. AdvaMed has warned the limit could halve capacity at commercial sterilizing plants, and the FDA has cautioned that there is a lack of viable alternatives to EtO for many devices. The ...
- Source: drugdu
- 145
- July 28, 2023
Octapharma Secures FDA Nod for Warfarin Reversal Agent Balfaxar

More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication. But using a blood thinner carries risks of its own as patients become prone to bleeding, particularly during urgent surgery or other invasive procedures. To combat the risk, Swiss plasma specialist Octapharma has developed a treatment that rapidly restores the blood’s ability to coagulate. On Wednesday, the FDA signed off on the company’s Balfaxar (prothrombin complex concentrate, human-lans). Already marketed as Octaplex in Europe and Canada, Balfaxar is for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonists such as warfarin. Balfaxar, which is a lyophilized powder for reconstitution, is provided with sterile water for injection by way of a new transfer device called Nextaro. The drug earned approval based on a phase 3 trial that ...
- Source: drugdu
- 141
- July 28, 2023
FDA Clears Tarsus’ Xdemvy as First Treatment for Common Eyelid Disease

Patients with the eyelid disease Demodex blepharitis can now see a cure in Tarsus Pharmaceuticals’ Xdemvy, the first FDA-approved treatment for an ailment that affects some 25 million Americans. The eye drops directly target Demodex mites, an ectoparasite infestation that causes the disease. Tarsus expects Xdemvy, an eye drop formulation of pet flea and tick treatment lotilaner, to be available by the end of August. The company has already started marketing for the often-misdiagnosed disease with a campaign called “Don’t Freak Out. Get Checked Out,” which launched in May. And last year, the company started a marketing campaign called “Look at the Lids,” which encourages eye doctors to screen for the condition. In two trials involving more than 833 patients, investigators testing the drug noted improvement in collarettes, which is the accumulation of the mite’s waste and eggs. Before Xdemvy, the 1 in every 12 U.S. adults who suffer ...
- Source: drugdu
- 106
- July 27, 2023
BD Gains FDA Clearance to Relaunch Alaris Infusion Pump After Recalls

Dive Brief The Food and Drug Administration has granted Becton Dickinson 510(k) clearance for its updated Alaris infusion pump, paving the way for the company to begin distributing the system again and to remediate or replace all older versions of the device in the field, BD said Friday. The FDA’s green light comes two years after the company filed a new submission for modifications to the pump, which delivers medications and other fluids intravenously to patients, following a series of recalls due to system malfunctions. A large installed base of Alaris systems remains in hospitals. BD said it will address all recall requirements still open to bring those devices into compliance with the FDA clearance, including hardware, software and cybersecurity updates. Dive Insight Widely used in healthcare, infusion pumps from a number of manufacturers have been among the devices that frequently appear on the ...
- Source: drugdu
- 252
- July 27, 2023
ADC Therapeutics Pulls the Plug on Zynlonta Study After Partial FDA Hold

A week after ADC Therapeutics paused its Zynlonta trial to review seven deaths and five other respiratory events in patients who received the drug, the company has scrapped the study altogether following an FDA partial clinical hold. The trial was testing the drug, combined with Roche’s Rituxan, in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Citing the “challenges of defining the addressable segment” of the difficult-to-treat population, ADC believes the benefit-risk profile “does not support” the continuation of the study, the company said in a release. The call came after a meeting with the FDA, in which the agency slapped a partial hold on enrolling new patients in the trial. However, the agency said patients who are already on the drug and seeing clinical benefits can remain enrolled after reconsenting. After those patients are treated, ADC will take steps to wrap up the trial. ...
- Source: drugdu
- 110
- July 25, 2023
AstraZeneca/Sanofi’s RSV antibody receives FDA approval for use in infants

AstraZeneca and Sanofi’s Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, the companies announced. The US Food and Drug Administration’s (FDA) decision makes the long-acting antibody the first preventive option approved to protect a broad infant population, including those born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease. The approval, which also applies to children aged up to 24 months who remain vulnerable to severe RSV disease through their second RSV season, was based on results from the Beyfortus clinical development programme spanning three pivotal late-stage clinical trials and follows a unanimous vote by the Antimicrobial Drugs Advisory Committee on the favourable benefit-risk profile of the drug. Across all clinical endpoints, a single dose of Beyfortus ...
- Source: drugdu
- 121
- July 22, 2023
Gilead’s COVID-19 Treatment Approved by FDA for Patients with Severe Renal Impairment

Gilead Sciences has announced that its COVID-19 treatment, Veklury (remdesivir), has been approved by the US Food and Drug Administration (FDA) to treat patients with severe renal impairment, including those on dialysis. The drug is already approved in the US to treat COVID-19 in adults and paediatric patients who are hospitalised or have mild-to-moderate COVID-19 and are at high risk for progression to severe illness. However, its use has previously been limited among patients with severe renal impairment due to insufficient data. The FDA’s latest decision makes Veklury the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. Gilead’s supplemental new drug application was supported by positive results from a phase 1 study as well as data from the phase 3 REDPINE trial that demonstrated the efficacy and safety profile of Veklury among patients with moderately and severely ...
- Source: drugdu
- 120
- July 19, 2023
FDA to Decide on Daiichi Sankyo’s Quizartinib for AML

Following a three-month delay to provide more time for review, the FDA is scheduled on July 24 to decide on Daiichi Sankyo’s proposal to administer quizartinib in combination with standard chemotherapy to treat patients with acute myeloid leukemia (AML). The FDA first accepted Daiichi Sankyo’s NDA in October 2022 and granted it Priority Review, which is meant to accelerate the regulator’s decision. However, in April 2023, the FDA pushed the action date back by three months to accommodate updates to the proposed Risk Evaluation and Mitigation Strategies for quizartinib. Daiichi Sankyo is backing its NDA with data from the Phase III QuANTUM-First trial, which demonstrated that quizartinib can cut the risk of death by 22.4% in AML patients compared to chemotherapy alone. This advantage persisted until 40 months of follow-up, at which point the quizartinib arm had more than double the median overall survival of placebo comparators. ...
- Source: drugdu
- 117
- July 18, 2023
FDA Greenlights First Over-the-Counter Birth Control Pill

Women of all ages in America will soon have access to a birth control pill that does not require a prescription, after the US Food and Drug Administration (FDA) approved Perrigo’s Opill (norgestrel). The progestin-only pill will be the first contraceptive medication in the US that can be bought from the same aisle as paracetamol or toothpaste. Marketed as Opill, Perrigo gained control of the drug after an acquisition of HRA Pharma in 2022. In a statement, the FDA said that the non-prescription availability of the medicine will help reduce barriers to accessing contraceptives. The once-a-day pill should be available early next year, but its pricing remains to be announced. The approval comes amidst a widening cultural divide regarding women’s health rights. Many US states have introduced laws that ban abortion after the US Supreme Court overturned Roe v Wade. Opill’s availability opens accessibility avenues to women’s ...
- Source: drugdu
- 131
- July 15, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.