Search Results for “FDA” – Page 42 – media

Iveric Gets FDA Approval in Geographic Atrophy After Being Acquired by Astellas

By Tristan Manalac Pictured: Astellas’ American headquarters in Illinois/iStock, JHVEPhoto The FDA on Friday approved Iveric Bio’s intravitreal avacincaptad pegol, now to be marketed as Izervay, for the treatment of geographic atrophy secondary to age-related macular degeneration. The regulatory win comes three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion. The companies completed the acquisition last month. Friday’s approval makes Izervay the first authorized geographic atrophy (GA) treatment that has significantly slowed down GA progression at 12 months across two Phase III studies, according to Astellas’ announcement. The eye injection also offers a new treatment option to physicians and patients across the U.S., Iveric Bio President Pravin Dugel said in a statement. Discovered and developed by Iveric, Izervay is an intravitreally administered inhibitor of the complement C5 protein. By blocking the cleavage of C5, the eye injection also disrupts more downstream processes, including the formation ...
- Source: drugdu
- 208
- August 9, 2023
FDA Approves Biogen, Sage’s Zurzuvae as First Pill for Postpartum Depression

By Heather McKenzie Pictured: FDA Headquarters/iStock, Grandbrothers In a bittersweet decision for Biogen and Sage Therapeutics, the FDA approved the fast-acting therapy zuranolone Friday as the first pill for postpartum depression—but rejected the treatment for major depressive disorder. Zuranolone—to be marketed as Zurzuvae in postpartum depression (PPD) —is only the second treatment for this indication and the first pill that can be taken at home. Prior to Zurzuvae, there was only one FDA-approved treatment for PPD—Sage’s Zulresso (brexanolone)—but as it must be administered intravenously at a hospital, it is out of reach for many women, Fortune Well reported. Zurzuvae also marks a significant change from the current treatment paradigm, which consists of drugs that are longer acting, showing efficacy typically within six to eight weeks, Sage Chief Business Officer Chris Benecchi, told BioSpace in a previous interview. However, the fast-acting pill—jointly developed by Biogen and Sage—can improve symptoms in as ...
- Source: drugdu
- 101
- August 8, 2023
With Takeda and Hutchmed hot on the trail, Taiho wins FDA nod for stronger Lonsurf regimen in colorectal cancer

Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen. Instead of a single-agent regimen, the FDA on Wednesday cleared Lonsurf to be used alongside bevacizumab for previously treated metastatic colorectal cancer. Patients who have tried an anti-VEGF inhibitor such as bevacizumab—originally developed by Roche as Avastin—may also qualify for this new combo. The Lonsurf-bevacizumab cocktail proved to be more efficacious than Taiho’s drug alone. Compared with Lonsurf monotherapy, the new combination significantly reduced the risk of death by 39% in a group of patients who had previously received a maximum of two prior chemotherapy regimens and an anti-VEGF agent, plus, in some cases, an anti-EGFR therapy such as Eli Lilly’s Erbitux. In that phase 3 trial, patients who received the combo lived a median 10.8 months, while ...
- Source: drugdu
- 130
- August 4, 2023
Terumo receives FDA clearance for automated whole blood processing system

Dive Brief Terumo Blood and Cell Technologies received clearance from the Food and Drug Administration for what it claims is the first whole blood automation device available in the U.S. The Reveos Automated Whole Blood System processes blood into platelets and other components in a single centrifugation cycle, eliminating some manual steps to separate platelets from the rest of the blood. The device can help blood centers make the process of collecting platelets from blood donations more efficient, increasing availability for people who need them for treatment, Chetan Makam, general manager of Terumo’s global blood solutions business, said in an interview. Dive Insight Platelets are used to treat trauma patients, for procedures like heart surgeries, and for patients who are undergoing chemotherapy. Demand for platelets continues to increase, Makam said. Currently, the majority of platelets available for transfusion in the U.S. come from a process called apheresis, where a donor’s ...
- Source: drugdu
- 114
- August 3, 2023
Non-profit receives FDA approval to supply cheaper OTC naloxone

The US Food and Drug Administration (FDA) approved the second over-the-counter (OTC) naloxone nasal spray product, RiVive (3mg) by non-profit pharmaceutical company Harm Reduction Therapeutics, for the emergency treatment of known or suspected opioid overdose. This approval follows the agency’s approval of Emergent BioSolutions’ Narcan in March 2023, as the agency has recently increased efforts to address the opioid crisis. The FDA also approved the first generic non-prescription naloxone drug in July 2023. Naloxone reverses opioid overdoses by blocking opioid receptors, thus preventing the drugs’ addictive effects. Harm Reduction Therapeutics has announced that the drug will be available by early 2024 and be primarily supplied to state governments and US harm organisations at “costs lower than other opioid antagonist nasal sprays”. The US-based non-profit organisation has said that the first 200,000 doses (10% of projected initial annual product production) of RiVive will be available free of charge. ...
- Source: drugdu
- 127
- August 2, 2023
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
- 101
- 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
- 144
- 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
- 135
- 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
- 103
- 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
- 244
- July 27, 2023

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