The U.S. Food and Drug Administration has approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of a rare, genetic immune disorder Wiskott-Aldrich syndrome, or WAS. Waskyra is indicated for pediatric patients six months and older and adults with WAS who...
The U.S. Food and Drug Administration has approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher pilot program, marking the first approval achieved through this review pathway. The approval was completed in just two months, representing a major reduction of the review timeline for this type of application. "Over the last few decades, America l
The U.S. Food and Drug Administration announced that it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic...
The Office of the United States Trade Representative, the Department of Commerce, and the Department of Health and Human Services have announced that the U.S. Government has reached an agreement in principle on pharmaceutical pricing with the United Kingdom. In the U.S.-U.K. Economic Prosperity Deal,...
Antibiotics remain vital to modern medicine, yet the report by Newmarket Strategy, a Healthcare consultancy, warned that reliable access is under growing threat, with experts urging immediate policy reforms. Specifically, the report emphasised the growing threat to the sustainable European supply...
The U.S. Food and Drug Administration has announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost "generic" alternatives to biologic drugs that treat serious and chronic diseases. In a new draft guidance, the FDA proposes major updates to...
One in six laboratory-confirmed bacterial infections causing common infections in people worldwide in 2023 were resistant to antibiotic treatments, according to a new report by the World Health Organization.. Between 2018 and 2023, antibiotic resistance rose in more than 40 percent of the pathogen-antibiotic combinations monitored, with an average annual increase of 5-15 percent, says the report
SCYNEXIS (SCYX) Tuesday reported positive Phase 1 results for its next-generation triterpenoid antifungal for invasive fungal infections, SCY-247. SCY-247 was well tolerated, with only mild to moderate adverse events reported in the study, which involved 88 healthy participants.
President Donald Trump has announced that he will impose 100 percent tariff on imports of brand-name or patented pharmaceutical products from next month unless the drug manufacturing company establishes a production plant in the United States. "Starting October 1st, 2025, we will be imposing a 100%...
A new report from the Centers for Disease Control and Prevention highlights a dramatic increase in a dangerous type of drug-resistant bacteria called NDM-producing carbapenem-resistant Enterobacterales, or NDM-CRE. The report, titled 'Changes in Carbapenemase-Producing Carbapenem-Resistant Enterobacterales,...
As part of its broader strategy to address the opioid crisis, the U.S. Food and Drug Administration has issued draft guidance titled 'Development of Non-Opioid Analgesics for Chronic Pain' to accelerate safe and effective non-opioid treatments and to reduce prescription-related opioid misuse. The...
British drug major GSK plc (GSK, GSK.L) announced Monday that the US Food and Drug Administration has accepted for priority review a supplemental New Drug Application for gepotidacin as an oral option for the treatment of uncomplicated urogenital gonorrhoea in patients 12 years of age and older. The...
President Donald Trump has sent letters to leading pharmaceutical manufacturers outlining the steps they must take to bring down the prices of prescription drugs in the United States to match the lowest price offered in other developed nation, known as the most-favored-nation, or MFN, price. Trump called on manufacturers to provide MFN prices to every single Medicaid patient. In the letter, the
Biopharmaceutical company Akeso Inc. (AKESF) announced Monday that China's National Medical Products Administration or NMPA has accepted the supplementary New Drug Application or sNDA for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced...
Novartis Pharma AG, affiliated to Swiss drug major Novartis AG (NVS), announced Tuesday that Coartem (artemether-lumefantrine) Baby has been approved by Swissmedic as the first malaria medicine for newborns and young infants. The company added that eight African countries also participated in the...
January 30, 2026 15:51 ET The Federal Reserve policy decision was the main event in the final week of January, which saw a heavy flow of economics news. Several data reflecting the trends in the U.S. economy were also released during the week. The interest rate decision from Canada also was in focus. In Europe, economic sentiment data gained attention. The policy decision from Singapore was the highlight in Asia.