https://www.bioworld.com/rss en-us The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection. http://www.bioworld.com/articles/732532 Fri, 10 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732532-hlb-hengrui-receive-third-us-fda-rejection-on-liver-cancer-combo Liver tumor treatment conceptual illustration Fate Therapeutics Inc. has obtained IND clearance from the FDA for FT-839, the company’s next-generation, off-the-shelf CAR T-cell product candidate targeting CD19 and CD38 for autoimmune diseases. http://www.bioworld.com/articles/732546 Fri, 10 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732546-fate-therapeutics-ft-839-gains-ind-clearance Illustration of CAR T cells What appears to be a routine item on a routine list of the U.S. Department of Health and Human Services’ (HHS) proposed rulemakings for the next fiscal year is being seen as anything but routine, given HHS Secretary Robert Kennedy’s stance on vaccines and several commonly used drugs. http://www.bioworld.com/articles/732516 Thu, 09 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732516-covid-19-injuries-posting-of-crls-on-hhs-2027-rulemaking-agenda US flag and HHS logo Credit: mehaniq41 Urogen Pharma Ltd. has obtained IND approval from the FDA for UGN-501, a next-generation investigational oncolytic virus. A phase I study evaluating intravesical administration of UGN-501 in patients with non-muscle invasive bladder cancer (NMIBC) is expected to begin in the fourth quarter. http://www.bioworld.com/articles/732499 Thu, 09 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732499-urogens-ugn-501-gains-ind-clearance-for-bladder-cancer Art concept for bladder Coregen Inc. has obtained IND clearance from the FDA for CRG-150, a novel adoptive cell therapy targeting SRC-3 (steroid receptor coactivator 3). http://www.bioworld.com/articles/732484 Wed, 08 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732484-coregens-crg-150-gains-ind-clearance-for-solid-tumors Illustration of lymphocytes attacking cancer cell LTZ Therapeutics Inc.’s LTZ-232 has gained IND clearance from the FDA, enabling initiation of a phase I study in patients with advanced metastatic colorectal cancer and other solid tumors. http://www.bioworld.com/articles/732481 Wed, 08 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732481-fda-clears-ind-for-ltz-therapeutics-ltz-232 Macrophage and cancer cell The House Select Committee on China launched an investigation into clinical trials involving U.S. companies that are conducted at Chinese military hospitals and in Xinjiang, China. http://www.bioworld.com/articles/732477 Tue, 07 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732477-some-clinical-trials-in-china-under-us-congressional-scrutiny China and U.S. flags Opus Genetics Inc. has secured U.S. FDA alignment on an eight-patient phase III trial of its lead gene therapy, OPGx-LCA5, for an ultra-rare form of inherited childhood blindness. http://www.bioworld.com/articles/732420 Tue, 07 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732420-opus-aligns-with-fda-on-rare-eye-disease-gene-therapy-trial Eye and DNA illustration Vera Therapeutics Inc. looks to get an almost five-month head start over a competitor, Vertex Pharmaceuticals Inc., as the U.S. FDA cleared its Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for treating immunoglobulin A nephropathy (IgAN). The accelerated approval, which came on the July 7 PDUFA date, indicates Trutakna for use in reducing proteinuria in adults with primary IgAN at risk for disease progression. The drug is administered once weekly via auto-injector. http://www.bioworld.com/articles/732416 Tue, 07 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732416-veras-trutakna-wins-fda-nod-as-first-dual-inhibitor-for-igan Kidneys Ascletis Pharma Inc. has submitted two IND applications to the FDA for ASC-36 once-monthly injection and ASC-36_35 once-monthly injection co-formulation for the treatment of obesity. http://www.bioworld.com/articles/732397 Mon, 06 Jul 2026 09:00:00 -0400 https://www.bioworld.com/articles/732397-ascletis-submits-inds-for-asc-36-and-asc-36-35-for-obesity Bathroom scale and injector pens The House Select Committee on China launched an investigation into clinical trials involving U.S. companies that are conducted at Chinese military hospitals and in Xinjiang, China. http://www.bioworld.com/articles/732259 Wed, 01 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732259-some-clinical-trials-in-china-under-us-congressional-scrutiny China and U.S. flags Orca Bio Inc. is bringing to market a precision-engineered cell therapy approach designed to improve outcomes in patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) following U.S. FDA approval of Tregzi, a first-of-its-kind, personalized cell therapy. http://www.bioworld.com/articles/732255 Wed, 01 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732255-orcas-t-cell-therapy-approach-to-hsct-wins-fda-nod-as-tregzi FDA approval seal on blue glittering background Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8. http://www.bioworld.com/articles/732352 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732352-otsukas-centanafadine-scores-in-adhd-comorbid-anxiety-trial Illustration of woman with anxiety, ADHD The U.S. FDA’s new Precheck Pilot Program is taking flight with seven biopharma companies on board. As part of the Trump administration’s efforts to encourage onshoring of biopharma manufacturing, the program is intended to increase regulatory predictability, facilitate the construction of U.S. manufacturing sites and streamline the FDA’s plant assessments in advance of a specific product application. http://www.bioworld.com/articles/732244 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732244-fda-clears-first-flight-of-precheck-rx-manufacturing-pilot The academic authors of the paper describing the pivotal trial of Amgen Inc.’s Tavneos (avacopan) have retracted it from The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded. The New England Journal of Medicine because the primary endpoint assessments of nine patients were “re-adjudicated” after the database was locked and the study unblinded.]]> http://www.bioworld.com/articles/732242 Tue, 30 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732242-nejm-paper-on-tavneos-pivotal-trial-retracted-by-academic-authors Photo of pen and marker on science journal article With the U.S. FDA go-ahead granted June 26 for Viridian Therapeutics Inc.’s IGF-1R antagonist Lumvoa (veligrotug-vvze, or “veli”) as a new thyroid eye disease (TED) therapy – due to launch immediately, the company said – Wall Street will be watching near-term payer dynamics. The drug is set to take on similarly targeted Tepezza (teprotumumab-trbw), owned by Amgen Inc. and approved in January 2020 to treat TED. http://www.bioworld.com/articles/732231 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732231-new-viridian-meridian-hopes-veli-high-in-ted-post-fda-win Illustration of a road with three destination markers While the U.S. Supreme Court made it clear earlier this month in Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts. Hikma v. Amarin that skinny labels are still on the board for generics, the court didn’t resolve all disagreements over the generic carveouts.]]> http://www.bioworld.com/articles/732229 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732229-the-court-said-what-it-said-dc-circuit-tells-norwich Judge's gavel with US flag Ready or not, the future has arrived. Novel AI and brain-computer interface (BCI) systems are no longer confined to the realm of science fiction. As an increasingly intertwined human-machine model moves closer to adoption in real-world clinical and military practice, technological advances are sparking concerns over public health, ethics and national security. http://www.bioworld.com/articles/732225 Mon, 29 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732225-ascending-bci-systems-deepen-national-security-ethical-concerns Brain made of chip and circuits Viridian Therapeutics Inc.’s U.S. FDA clearance of Lumvoa (veligrotug-vvze) to treat thyroid eye disease (TED) includes labeling for chronic as well as active forms, and fewer infusions – plus fast, durable effects – should give the IGF-1R antagonist leverage in competing with similarly targeted TED drug Tepezza (teprotumumab-trbw), owned by Amgen Inc. and approved in January 2020. http://www.bioworld.com/articles/732326 Sun, 28 Jun 2026 00:00:00 -0400 https://www.bioworld.com/articles/732326-fda-says-yes-to-viridians-lumvoa-in-ted Close up of man's eye Otsuka Pharmaceutical Co. Ltd. reported another clinical study win with once-daily centanafadine, a non-stimulant compound targeting attention deficit hyperactivity disorder (ADHD). Top-line results of a dedicated phase IIIb study in patients with ADHD and comorbid anxiety found that centanafadine met the primary endpoint, defined as score improvements on the Adult Investigator Symptom Rating Scale, compared with placebo at week 8. http://www.bioworld.com/articles/732174 Fri, 26 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732174-otsukas-centanafadine-scores-in-adhd-comorbid-anxiety-trial Illustration of woman with anxiety, ADHD The eighth version of the Prescription Drug User Fee Act (PDUFA) is up for renewal next year, but the bulk of the negotiations between the drug development industry and the U.S. FDA is largely complete. At the BIO International Convention, representatives from the industry and trade organization provided an overview of what was agreed upon during the 127 negotiating sessions that were needed to arrive at the commitment letter, which will be sent to Congress later in 2026. http://www.bioworld.com/articles/732158 Thu, 25 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732158-bio-2026-industry-negotiators-preview-pdufa-viii FDA logo on textured paper Credit: Araki Illustrations - stock.adobe.com Ascletis Pharma Inc. has received IND clearance from the FDA for ASC-35, a once-monthly subcutaneously administered GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual peptide agonist, for the treatment of obesity. http://www.bioworld.com/articles/732131 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732131-fda-clears-ind-for-ascletis-pharmas-asc-35-for-obesity Unixell Biotechnology Co. Ltd. has obtained IND clearance from the FDA for UX-DA003, its allogeneic induced pluripotent stem cell (iPSC)-derived therapy for Parkinson’s disease. IND approval was also gained in China earlier this month, enabling concurrent clinical development in both China and the U.S. http://www.bioworld.com/articles/732129 Thu, 25 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732129-unixells-ux-da003-cleared-for-clinic-in-us-and-china Stem cells As expected, and following impressive phase III data released last September, Ionis Pharmaceuticals Inc. won U.S. FDA approval of Tryngolza (olezarsen) for adults with severe hypertriglyceridemia, unlocking a larger indication and one that held both priority review and breakthrough therapy designations. http://www.bioworld.com/articles/732162 Thu, 25 Jun 2026 08:00:00 -0400 https://www.bioworld.com/articles/732162-ionis-wins-wider-tryngolza-approval-for-hypertriglyceridemia Tryngolza pen and packaging Credit: Ionis Pharmaceuticals Inc. J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. http://www.bioworld.com/articles/732153 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732153-j-pharma-drives-first-cancer-lat1-to-phase-iii-study-with-fda-nod Illustration of cancer in the bile ducts The U.S. FDA approved 24 drugs in May 2026, the busiest month of the year so far. Up from April’s 14, it brings the year-to-date total to 84 approvals. Through May, the agency has cleared 20 new molecular entities, a pace that, if sustained, would put 2026 on track to approach or exceed several recent years. http://www.bioworld.com/articles/732067 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732067-us-fda-approves-24-drugs-in-may-in-busiest-month-of-2026 Xocova blister pack Credit: Shionogi & Co. Ltd. With increasing competition from China and other countries, the U.S. Department of Health and Human Services is rolling out Operation Trailblazer, a department-wide strategy to once again make the U.S. the go-to destination for early stage drug development. http://www.bioworld.com/articles/732065 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732065-fda-looks-to-pilot-speedier-early-stage-rx-development FDA headquarters signage Credit: Tada Images - stock.adobe.com Anhorn Medicines Co. Ltd. has obtained IND clearance from the FDA for its lead neuroprotective candidate, AH-008, for the prevention of chemotherapy-induced peripheral neuropathy. http://www.bioworld.com/articles/732111 Tue, 23 Jun 2026 09:00:00 -0400 https://www.bioworld.com/articles/732111-anhorn-medicines-gains-ind-clearance-for-neuroprotectant-ah-008 Art concept for pain J-Pharma Co. Ltd. is progressing the most clinically advanced L-type amino acid transport 1 (LAT1) inhibitor, nanvuranlat (JPH‑203), in a global phase III Beacon-BTC study of biliary tract cancer following U.S. FDA alignment. http://www.bioworld.com/articles/731921 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731921-j-pharma-drives-first-cancer-lat1-to-phase-iii-study-with-fda-nod Illustration of cancer in the bile ducts Four years after the U.S. FDA issued a complete response letter for Spero Therapeutics Inc.’s oral antibiotic, tebipenem pivoxil hydrobromide, to treat complicated urinary tract infections (cUTI), including pyelonephritis, the agency approved the drug based on phase III data showing noninferiority to intravenous imipenem-cilastatin. http://www.bioworld.com/articles/731919 Thu, 18 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731919-gsk-speros-oral-antibiotic-utebzi-for-cuti-wins-us-fda-nod FDA Approved stamp with pills