iStock, Jolygon Findings from the Phase III VESALIUS-CV study reinforce the cholesterol-lowering benefit of Repatha in high-risk patients without prior cardiovascular disease, for which the drug was approved in August 2024. Amgen’s PCSK9 blocker Repatha significantly lowered the risk of heart complications in patients who had no prior history of cardiovascular disease, according to a topline Phase III readout on Thursday, further cementing the drug as a primary prevention option for cardiovas

iStock, Grandfailure Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space. The FDA has spilled a lot of ink communicating its desire to accelerate therapies across a range of diseases. To date, it has mostly been just that, talk, according to observers. But

An expansive biomarker study confirmed OV329 delivered statistically significant inhibition of GABA-AT as measured across multiple metrics OV329 matched or exceeded inhibition demonstrated by therapeutic doses of first-generation GABA-AT inhibitor, vigabatrin (VGB), as measured on transcranial magnetic stimulation (TMS) 1 Findings confirm OV329 penetrates the brain, engages the target and achieves biological modulation as expected of elevated levels of GABA, the major inhibitory neurotransmitter

Pictured: Sign of U.S. Department of Health & Huma iStock, Zolak Expanded exemptions for orphan drugs could mean prolonged protections for top-selling drugs like Merck’s Keytruda, which was initially approved under this designation in 2014. The U.S. Centers for Medicare and Medicaid Services has released finalized guidelines for the Inflation Reduction Act’s drug price negotiation program, cementing broader exclusions from the negotiations for orphan drugs. According to experts, however, do

ANN ARBOR, Mich., Oct. 03, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laboratories Ltd. (together, Dr. Reddy’s Laboratories). This agreement resolves the patent litigation brought by Esperion against Dr. Reddy’s Laboratories in response to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of each of NE

BOSTON--(BUSINESS WIRE)--Oct. 3, 2025-- Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it will present one poster and one oral presentation at the 2025 HAEi Regional Conference EMEA, taking place October 10-12, 2025 in Rome, Italy. Dr. William Lumry, M.D., ARA Research Center, Dallas, TX, United States of America, will share information on the global Phase 3 trial of na

WALTHAM, Mass., Oct. 03, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced multiple upcoming poster presentations at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, taking place from November 6-9, 2025 at the Gaylord National Convention Center in National Harbor, Maryland. Xilio plans to present clinical data

The US Food and Drug Administration (FDA) has approved Eli Lilly’s Inluriyo (imlunestrant) to treat advanced or metastatic breast cancer, following positive phase 3 trial data. Certain breast cancers develop ESR1 mutations, which cause oestrogen receptors to become overactive and drive tumour growth. Inluriyo is a once-daily oral oestrogen receptor antagonist that binds to, blocks and degrades these overactive receptors. “This therapy represents an important step toward advancing innovative, all

WASHINGTON, Oct. 2, 2025 /PRNewswire/ -- Family Research Council President Tony Perkins released the following statement reacting to the Food and Drug Administration's approval of a generic form of the abortion drug mifepristone hours ahead of the government shutdown: "Despite the mounting evidence of the dangers of the abortion kill pills, the FDA approved a generic version of mifepristone just hours before the federal government shutdown. Under Biden-era policies, abortionists are operating li

Vaxcyte’s North Carolina investment comes as many of its biopharma peers have also elected to do business in the Tar Heel State. As North Carolina’s biopharma hotbed enjoys an onshoring investment rush, clinical-stage vaccine developer Vaxcyte is the latest company to put down manufacturing roots in the state.As with other drugmakers who’ve embarked on North Carolina production projects in recent months, Vaxcyte plans to leverage the extensive CDMO capacity offered there.Vaxcyte is payin