62 stories found
The Food and Drug Administration granted approval for a novel therapy targeting a rare form of blood cancer alongside clearance for Juul’s updated vaping system featuring age-verification technology. These decisions mark significant regulatory milestones for both oncology and tobacco product oversight.
The U.S. Food and Drug Administration has approved Gilead Sciences’ new once-daily combination medication for treating HIV infection. The approval aims to simplify long-term antiretroviral therapy and improve patient adherence.
The U.S. Food and Drug Administration has approved a new once-daily oral medication for advanced pancreatic cancer, marking a significant clinical breakthrough that nearly doubled patient survival rates in trials. The approval has prompted analysts to raise price targets for associated biotechnology firms.
The US FDA has raised the salmonella risk to the highest level for 19 million eggs, with nearly 100 people infected across 17 states and 26 hospitalized, though officials claim the situation is under control.
The US Food and Drug Administration has approved its first new sunscreen ingredient in decades, signaling potential opportunities for South Korea's K-beauty industry, though challenges remain.
EuBiologics announced it has completed the registration of its EcML vaccine adjuvant with the US FDA's Drug Master File system, obtaining an official filing number to facilitate future vaccine development.
The FDA has issued a recall for nearly 1.6 million dozen eggs from Midwest Poultry Services due to potential Salmonella contamination. The affected eggs were distributed across five US states, prompting health concerns amid a surge in stomach illness cases.
South Korean biotechnology company Seegene's US subsidiary has been granted emergency use authorization by the US FDA for a molecular diagnostic test capable of detecting four viruses associated with skin and mucosal lesions.
Moderna's stock has seen a significant surge following a unanimous FDA vote, but Wall Street's average price target suggests a substantial decline, creating a discrepancy for investors.
An article discusses the significance of India's first US FDA-approved antibiotic and its potential impact on the fight against superbugs.
The US FDA is set to review an AI-based tool designed to predict drug-related liver damage.
The US FDA has approved the first implant to treat rheumatoid arthritis by sending electrical impulses to the vagus nerve, expanding the therapeutic applications of vagus nerve stimulation.
The U.S. FDA has proposed new restrictions on the mass compounding of weight-loss drugs manufactured by Novo Nordisk and Eli Lilly.
The U.S. FDA is initiating a pilot program to monitor clinical trial data in real time, aiming to accelerate drug approval processes.
The U.S. Food and Drug Administration (FDA) has reauthorized the marketing of IQOS as a modified risk tobacco product, making Philip Morris International the sole company with such authorizations for heated tobacco products.
The US FDA has issued a warning regarding cases of liver injury associated with a rare disease drug manufactured by Amgen.
The U.S. Food and Drug Administration (FDA) has granted approval for Denali Therapeutics' new therapy designed to treat a genetic disorder in children.
A unit of Aurobindo Pharma's arm in Rajasthan, India, has been classified as 'Official Action Indicated' (OAI) by the U.S. Food and Drug Administration.
Novo Nordisk has reportedly violated reporting protocols for potential side effects, according to the US Food and Drug Administration.
US FDA warns Novo again about misleading drug advertising Reuters
US FDA approves Vanda's antipsychotic pill, shares climb Reuters
The US Food and Drug Administration has approved Eli Lilly's diabetes drug Mounjaro to reduce cardiovascular risk, expanding its approved therapeutic uses beyond blood sugar management.
Revolution Medicines received US FDA approval for a novel once-daily treatment for advanced pancreatic cancer, but the drug carries a steep list price exceeding $475,000 per year.
The U.S. Food and Drug Administration (FDA) has granted clearance for a new Alzheimer's blood test developed by Roche and Eli Lilly. This approval marks a significant advancement in the diagnostic tools available for the disease.
The U.S. Food and Drug Administration (FDA) has proposed new regulations that would require food manufacturers to notify the agency before introducing new ingredients and additives into their products.
HLB Pep announced that it has registered its vasopressin active pharmaceutical ingredient with the US Food and Drug Administration’s Drug Master File system, advancing its push into global peptide drug markets for treating septic shock.
An advisory committee for the US FDA voted to relax restrictions on peptide drugs BPC-157, TB-500, and KPV, potentially allowing their prescription despite limited human research.
The U.S. Food and Drug Administration has announced it is investigating a separate cyclospora outbreak, distinct from previous incidents.
Merck's new cholesterol pill has received approval from the U.S. Food and Drug Administration (FDA). This powerful new medication is expected to offer a significant treatment option for patients.
Celltrion announced that its blood cancer treatment, Truxima, has been granted interchangeability designation by the US FDA, making it the first rituximab biosimilar to achieve this status and associated exclusivity.
Moderna's flu vaccine has received a unanimous endorsement from an FDA advisory panel, moving it closer to potential approval.
The U.S. Food and Drug Administration (FDA) has put forward a proposal to accelerate the development of gene therapies by leveraging existing scientific knowledge. This initiative aims to streamline the process for bringing new gene therapies to patients.
AstraZeneca has announced that its hypertension drug, Baxfendy, has received approval from the U.S. Food and Drug Administration (FDA). This approval marks a significant step for the treatment of hypertension.
The U.S. Food and Drug Administration has proposed removing certain weight-loss drugs from the list of medications that can be compounded, potentially impacting their availability.
The U.S. Justice Department has officially ended its criminal investigation into Federal Reserve Chair Jerome Powell, clearing him of any wrongdoing. This decision comes amid discussions surrounding potential nominations for the Federal Reserve.
Yuhan Corp.'s investigational drug YH35995 has been granted orphan drug designation by the US FDA for the treatment of Gaucher disease, a rare condition. This designation supports therapies for rare diseases with limited treatment options.
Novo Nordisk has secured US FDA approval for its once-weekly insulin Awiqli, expanding its presence in diabetes care and offering a new treatment option for type 2 diabetes.
US FDA approves higher dose of Novo's Wegovy under new fast-track review program Reuters
Johnson & Johnson said the U.S. Food and Drug Administration approved its once-daily psoriasis pill, the first oral option to rival best-selling shots.
US FDA approves Johnson & Johnson's blood cancer drug after speedy review Reuters
US FDA warns 30 telehealth firms over misleading ads for compounded weight‑loss drugs Reuters
The U.S. Food and Drug Administration has reversed its earlier decision and will now review Moderna's application for its modified influenza vaccine.
The U.S. Food and Drug Administration has approved updated seasonal COVID-19 vaccines from Pfizer-BioNTech and Moderna for the 2026–2027 period. Both formulations have been specifically adapted to target the emerging XFG viral variant.
Biotech firm Nicox has announced that the US FDA has scheduled a Prescription Drug User Fee Act (PDUFA) date of April 2027 for its novel glaucoma treatment, NCX 470.
Aurobindo Pharma's manufacturing plant in Raleigh has been classified as 'Voluntary Action Indicated' by the US FDA.
The U.S. Food and Drug Administration has given its approval for Moderna's mRNA-based influenza vaccine, marking a significant development in flu prevention.
The U.S. Food and Drug Administration has given its approval for the first pill designed to replace injectable treatments for managing high cholesterol levels.
The FDA is investigating multiple cyclosporiasis outbreaks across the US, with a new announcement adding to cases reported in the Midwest, including Michigan and four other states, and a new outbreak now linked to an unspecified product. These outbreaks have resulted in hundreds of hospitalizations since May, prompting public health officials to advise on symptom identification.
The FDA has retracted its initial positive cyclospora test on Taylor Farms lettuce, stating the finding was a false positive. Despite the retraction, the FDA remains focused on Taylor Farms lettuce as a potential source for the cyclospora outbreak, leading to a recall and public concern about lettuce consumption.
The United States Food and Drug Administration (FDA) has approved Trutakna (atacicept-vymj), a first-in-class treatment developed by Vera Therapeutics, aimed at reducing proteinuria in adults with primary immunoglobulin A nephropathy.
US FDA staff have highlighted potential risks associated with peptides, stating there is little evidence to support their claimed benefits.
The U.S. Food and Drug Administration has sent 25 letters to telehealth companies, cautioning them about claims made regarding compounded weight-loss drugs.
Big Tobacco companies have emerged favorably following a recent shake-up at the US Food and Drug Administration. This restructuring appears to have created a more advantageous regulatory environment for the industry.
A US federal appeals court has temporarily blocked the mail delivery of the abortion pill mifepristone, limiting access to the medication nationwide. This ruling restricts how the pill can be dispensed, pending further legal review.
The U.S. Food and Drug Administration (FDA) has announced that testing confirms the safety of the domestic infant formula supply.
The U.S. Food and Drug Administration (FDA) has renewed the authorization for Philip Morris International's IQOS heated tobacco products as modified risk tobacco products.
Indian drugmaker Granules plans to tighten its oversight processes after receiving a warning from the US FDA, according to an executive.
The U.S. Food and Drug Administration has approved Novo Nordisk's insulin injection for the treatment of type 2 diabetes. This approval marks a new development in diabetes management.
US FDA declines to approve Aldeyra's eye disorder drug, shares slump Reuters
US FDA's operations chief to retire, 30-year agency veteran to succeed TradingView
US FDA approves Eton's liquid therapy for rare water-balance disorder Reuters