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The U.S. Food and Drug Administration has approved Amgen (AMGN.O), opens new tab and AstraZeneca's (AZN.L), opens new tab drug for a type of chronic inflammatory sinus disease, the drugmakers said on Friday. The approval expands the use of the drug, Tezspire, as an add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps in adult and pediatric patients aged 12 years and older. The condition causes the sinuses to stay inflamed for 12 weeks or more and soft, noncancerous growths called polyps to form in the nose. Symptoms include facial pain, reduced sense of smell and nasal congestion. Tezspire is already approved as a single-use pre-filled syringe in the U.S., EU and other countries for add-on maintenance treatment for severe asthma. The approval is based on the results from a late-stage study in which the drug showed clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo. Tezspire also reduced the number of patients needing surgery for nasal polyps by 98% and reduced the need for oral steroids by 88%, the data showed. Data for Tezspire shows that it might be more effective than Sanofi (SASY.PA), opens new tab and Regeneron's (REGN.O), opens new tab Dupixent for patients with this condition, William Blair analyst...

The U.S. Food and Drug Administration on Friday approved labeling changes for Johnson & Johnson and its partner Legend Biotech's blood cancer therapy to include a boxed warning for a potentially fatal gastrointestinal condition. The FDA said it received reports that some patients treated with Carvykti developed a serious gut inflammation called IEC-EC, which in some cases led to life-threatening complications like bowel perforation and sepsis. Reports were received from clinical trials and postmarketing adverse event data, the FDA said. IEC-EC is a form of inflammation of the intestines triggered by the immune system. It was observed weeks to months after CAR-T therapy treatment with Carvykti in both clinical trials and after approval, the regulator said. Symptoms included persistent diarrhea, stomach pain and weight loss, often requiring intensive care and immune-suppressing drugs. Carvykti was first approved in February 2022 and received expanded approval in April 2024 for adults with relapsed or refractory multiple myeloma who had received at least one prior line of therapy. Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, found in the bone marrow. The FDA also updated the "clinical studies" section of the drug's prescribing information to include overall survival data from...

The U.S. Food and Drug Administration confirmed on Friday that toxic cough syrups linked to children's deaths in India had not been shipped to the United States. The World Health Organization has said India has a "regulatory gap" in screening locally sold syrup medicines. Make sense of the latest ESG trends affecting companies and governments with the Reuters Sustainable Switch newsletter. Sign up here. The U.S. FDA said it was aware of news reports of devastating, ongoing diethylene glycol and ethylene glycol contamination in children's cough and cold medicine in India. Indian authorities advised the public to avoid two more brands of cough syrup on Wednesday following the deaths of 17 children under age five, linked to a toxic ingredient. The children died in India over the past month after consuming cough medicine containing toxic diethylene glycol in quantities nearly 500 times the permissible limit, officials said. The deaths were all linked to the Coldrif medicine brand, which was banned after a test confirmed the presence of the chemical on October 2. India's health authority, the Central Drugs Standard Control Organization, informed the U.S. regulator that these products were not exported from India to any other country, the FDA said. The FDA also said it remains...

The FDA has approved roflumilast cream 0.05% (Zoryve; Arcutis Biotherapeutics) for children aged 2 to 5 years, meaning that as soon as later this month, they could have another topical therapeutic option to treat their mild to moderate atopic dermatitis.1 There is no limit to the duration of use, and the once-daily steroid-free cream can be used anywhere on the body. This approval marks the sixth FDA approval for roflumilast in just over 3 years, including for atopic dermatitis in pediatric patients 6 years and older in July 20242 and for plaque psoriasis in adults and adolescents 12 years and older in May 2025. “It is essential to have safe and effective treatments for children, who are often diagnosed with atopic dermatitis at a young age and can live with the condition across their lifetime. Young children often experience widespread disease, affecting large portions of their skin,” said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego and INTEGUMENT study investigator, in a statement. “Although topical steroids have been the standard treatment for years, they are not appropriate for long-term use.” The approval is based on results from 3 trials: phase 3 INTEGUMENT-PED (NCT04845620), phase 3...

The US Food and Drug Administration (FDA) has approved evinacumab (Evkeeza; Regeneron), a fully human monoclonal antibody that blocks angiopoietin-like 3 (ANGPTL3), as an adjunct to diet, exercise, and use of other lipid-lowering therapies (LLTs) for the treatment of children aged 1 to less than 5 years with homozygous familial hypercholesterolemia (HoFH), according to a news release from Regeneron. Evinacumab’s Past Indications This is the third approval for evinacumab’s HoFH indication. In 2021, the medication was approved for patients aged 12 and older with HoFH, and in 2023, the indication was expanded to include children aged 5 through 11 years. Original clinical trial data has demonstrated that evinacumab can lower low-density lipoprotein cholesterol (LDL-C) by up to 50% compared with placebo in this patient population. Approval for this new indication was based on safety and efficacy data gathered from 6 children living with HoFH who took part in the United States expanded access program or compassionate use program for evinacumab. Among this cohort, there were no new safety concerns identified, with the most common adverse reactions consisting of nasopharyngitis, influenza-like illness, dizziness, rhinorrhea, nausea, and fatigue. The patients in this cohort elicited similarly robust reductions in LDL-C, demonstrating continued efficacy in younger...

The U.S. Food and Drug Administration said on Friday it has launched a new pilot program to speed up the review process for generic drugs that are tested and manufactured entirely in the United States. The program is designed to encourage companies to invest in domestic drug production and research by offering faster approvals for products made with U.S.-sourced ingredients and tested within the country. Earlier this week, the FDA held a public meeting to discuss its broader efforts to support U.S. pharmaceutical manufacturing, including the PreCheck program, which aims to help set up high-priority drug facilities more quickly. The FDA said these steps will help strengthen the U.S. drug supply chain and bring high-quality, U.S.-made generic drugs to market more quickly. More than half of the pharmaceuticals distributed in the United States are made overseas, according to the health regulator. As of 2025, only 9% of companies that produce the key ingredients in drugs - known as active pharmaceutical ingredients - are based in the U.S., compared to 22% in China and 44% in India, the FDA said. "Over-reliance on foreign drug manufacturing and testing creates risks both to national security and patient access, and undermines investments in U.S. research, manufacturing and production," said...

The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals and Roche's combination therapy as a maintenance treatment for adult patients with a type of lung cancer, the regulator said on Thursday. Jazz's drug, Zepzelca, in combination with Roche's Tecentriq, is now approved for patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed after initial chemotherapy. This is an aggressive form of lung cancer that may spread to other parts of the body, including the bone marrow. "This approval marks the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, a highly aggressive disease for which treatment options have been limited," Roche said in a statement. Zepzelca is already approved as a second-line treatment — to be administered when the initial treatment fails — for the illness. "With the FDA approval, the combination will be eligible for reimbursement," Jazz Pharma told Reuters. Zepzelca's list price is $8,110, according to the company website as of January 14. Jazz Pharma noted that the cost does not change per indication. The combination therapy's approval is based on late-stage trial data showing a 46% reduction in disease progression and a 27% reduction in death risk compared with Tecentriq alone. The recommended dosing regimen...

The U.S. Food and Drug Administration has approved Evita Solution's generic version of the abortion drug, mifepristone, the regulator said. The FDA said in a letter dated September 30 it has approved Evita's generic version of Danco Laboratories' mifepristone, which is used to terminate pregnancy at up to 10 weeks. The drug is manufactured by the privately held company that describes its mission as being to "normalize abortion" and make it "accessible to all." GenBioPro, another private company, also sells a generic version of Danco Labs' mifepristone. The approval comes amid heightened scrutiny of abortion drugs, with the FDA currently reviewing the safety of mifepristone following pressure from conservative lawmakers and state attorneys general. U.S. Health Secretary Robert F. Kennedy Jr. said in a post on X that "the Biden administration removed mifepristone's in-person dispensing rule without studying the safety risks. We are filling that gap." "U.S. FDA only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug," he added. The FDA has said that after decades of use by millions of women in the United States and around the world, mifepristone has proven "extremely safe," and that studies have demonstrated that...

The U.S. Food and Drug Administration approved Crinetics Pharmaceuticals' drug to treat a rare hormonal disorder on Thursday, making it the first once-daily oral pill available for patients in the country. The drug, Palsonify, chemically known as paltusotine, was approved to treat acromegaly, a rare condition in which the pituitary gland in the brain produces excess growth hormone, causing the bones, organs and other tissues to grow bigger, caused due to a tumor on the pituitary gland. Treatment options for acromegaly include surgery to remove pituitary tumors, radiation therapy and medications such as somatostatin analogs that reduce growth hormone levels and may shrink tumors. The current standard-of-care involves monthly injections of drugs such as octreotide or lanreotide. Palsonify, to be administered once daily, will be available from early October. Crinetics said it is working closely with payers, healthcare providers and patient advocacy organizations to support those who may benefit from this treatment. The approval was backed by data from two late-stage studies that tested the drug's safety and efficacy in previously treated and medically untreated adults. In the studies, paltusotine, maintained IGF-1 levels - a protein that plays a role in moderating the growth hormone - in patients with acromegaly who switched from monthly injectable medications....

Eli Lilly said on Thursday the U.S. Food and Drug Administration has approved its treatment for a form of advanced breast cancer in adult patients who have received prior therapy. The therapy, Inluriyo, was approved based on data from a late-stage trial in which patients had a 38% lower chance of their cancer progressing or death compared to those on standard treatments, the drugmaker said. Metastatic breast cancer, also called Stage IV breast cancer, occurs when the disease has spread beyond the breast and nearby lymph nodes to other parts of the body, most commonly the bones, lungs, liver or brain. Some breast cancers develop ESR1 mutations, which make estrogen receptors overly active. These receptors normally help regulate cell growth, but when mutated, they can drive cancer progression. Inluriyo is designed to target these overactive receptors by binding to the estrogen receptor, blocking its activity and breaking it down to help slow the spread of the disease. The therapy is expected to be available in the United States in the next few weeks, with a list price of $22,500 per 28 days for the 400 mg dose, the company told Reuters in an email. Its label includes a warning for embryo-fetal toxicity, which refers to...