On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months. Read More

Draig Therapeutics Ltd. launched with a $140 million series A and an AMPA receptor modulator program that has completed phase I and will start a phase II trial in major depressive disorder later in 2025. The series A also will enable the company to advance two small-molecule GABA receptor modulators that have the potential to treat a range of neuropsychiatric disorders, into the clinic in 2026. Read More

An 85% remissions rate was found in updated results from Aptevo Therapeutics Inc.’s ongoing phase Ib/II Ranier study of mipletamig in one of the toughest blood cancers to treat. Read More

Immuneering Corp.’s phase IIa data from an ongoing trial in pancreatic cancer disclosed June 17 impressed Wall Street and brought renewed attention to the perennially difficult indication, at which drug developers continue to fling themselves with varied mechanisms. Read More

After years of conversations surrounding indirect research costs, academic groups are now under the gun to quickly come up with an alternative to the NIH’s proposed 15% across-the-board cap on indirect costs and the decades-old university-by-university negotiated rate that can exceed a 50% add-on to a grant. Read More

Avata Biosciences Holdings Ltd. and Oceanus Bio Inc. have inked a drug discovery and development deal worth up to $95 million for two of Avata’s cannabidiol compounds. Read More

Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell, up 34.80% from its listing price of $7.50 per share. Shares had kicked up to $15 at opening, reaching double its offering price. Read More

BioWorld's offices will be closed in observance of Juneteenth in the U.S. No issue will be published Thursday, June 19. Read More

Stay updated with BioWorld's latest index insights, featuring sector-specific charts that track the performance of companies in biopharma, drug development, cancer research, infectious diseases and neurological diseases. This page offers updates on index movement, as well as links to relevant stories about the biggest gainers and losers within each index. Explore the BioWorld index insights page for in-depth, real-time data and performance analysis. Read More

New hires and promotions in the biopharma industry, including: Arima, Maxion, Nodthera, Quiver, Relmada, Tharimmune. Read More

Biopharmas raising money in public or private financings, including: Adial, Alzecure, Enliven, Fibrobiologics, Hemostemix, Jyong, Polypid, Recce, Sanofi, Theralase, Zyus. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Azitra, Immuneering, Lyell, Mineralys, Spyre, Ventyx. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avata, Escugen, Glykos, Immedica, Intact, Oceanus, Orion, Processa, Sunrock. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Alligator, Capricor, CSL, Dyne, Ferrer, Geovax, GSK, Hemogenyx, Tisento. Read More