As part of its broader strategy to address the opioid crisis, the U.S. Food and Drug Administration has issued draft guidance titled 'Development of Non-Opioid Analgesics for Chronic Pain' to accelerate safe and effective non-opioid treatments and to reduce prescription-related opioid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...
Shares of Cidara Therapeutics, Inc. (CDTX) were surging around 86 percent in the pre-market activity on the Nasdaq, after the biotechnology company announced Monday positive topline results from its Phase 2b NAVIGATE trial evaluating CD388 for the prevention of seasonal influenza in healthy unvaccinated...
French pharmaceutical company AB Science SA (ABSCF.PK) announced Monday that a new peer-reviewed data provide strong evidence supporting Masitinib's potential for the treatment of alzheimers disease through a dual mechanism of cognitive enhancement and neuroprotection. The study is from an independent...
The U.S. Food and Drug Administration announced it has halted new clinical trials that involve sending living cells from American citizens to China and other hostile nations for genetic engineering, after which the cells are infused back into U.S. patients. The FDA now said it will require companies...
The U.S. Food and Drug Administration announced launch of a new program to issue Commissioner's National Priority Vouchers or CNPVs, which shortens review time significantly, with a view to support national health priorities. The new CNPV program, which will begin in 2025, aims to accelerate the drug review process for companies while maintaining the FDA's rigorous standards for safety, efficacy..
British drug major AstraZeneca Plc. (AZN.L, AZN) announced Friday that it has entered into a strategic research collaboration with Shijiazhuang City-based CSPC Pharmaceuticals Group Lts, which is focused on AI-enabled research. Under the deal terms, CSPC will receive an upfront payment of $110 million....
Shares of Unicycive Therapeutics, Inc. (UNCY) were losing around 20 percent in the pre-market activity on the Nasdaq after the company announced that the U.S. Food and Drug Administration identified deficiencies at a third-party manufacturing vendor. The company revealed the issue in an update on...
Shares of Axsome Therapeutics, Inc. (AXSM) were losing around 4 percent in the pre-market trading on the Nasdaq after the firm Monday announced that it has received a Refusal to File or RTF letter from the U.S. Food and Drug Administration for its New Drug Application (NDA) for AXS-14 (esreboxetine)...
Alnylam Pharmaceuticals, Inc. (ALNY) announced Monday that the European Commission or EC has granted approval for AMVUTTRA (vutrisiran) for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) as an additional indication. The RNA interference...
French drug major Sanofi S.A. (SNYNF,SNY) announced Tuesday that the US Food and Drug Administration has granted orphan drug designation to rilzabrutinib for sickle cell disease. This is the fourth orphan drug designation for rilzabrutinib in rare diseases. Sickle cell disease is a group of rare,...
Summit Therapeutics Inc. (SMMT) announced Friday positive topline results from the Phase III clinical trial, HARMONi, evaluating ivonescimab plus chemotherapy in patients with EGFR-Mutant non-small cell lung cancer or NSCLC. Based on the results of the HARMONi clinical trial, Summit said it intends...
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.