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Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Innovation drives CROs to win new business, but unchecked customization creates complexity that undermines reproducibility, weakens renewals and leads to turnover—making standardization a strategic necessity, not a constraint.
The 2022 search approach is no longer working. Companies need to think critically about how they are acquiring top regulatory, clinical and commercial executives or risk their programs in this new regulatory and market reality.
The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back.
Who is the highest paid CEO in all of pharma? In this special edition, BioSpace examines top paid CEOs and their pay packages.
Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners.
At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
Vijay Kumar, acting director of CBER’s Office of Therapeutic Products, will leave his role at a tumultuous time for the FDA.
Investment firm Deerfield Management is the latest to find a gem in China, which has been rising as a source of biotech innovation over the past few years.
With the failure in chronic spontaneous urticaria, Evommune’s story is now centered on its anti-IL-18 therapy EVO301, Oppenheimer said, which in February elicited a 33% placebo-adjusted improvement in eczema severity.
The delay is largely “benign” for Praxis Precision Medicines, according to Jefferies, which emphasized that the FDA did not flag safety or manufacturing issues.
Earlier this year, Amgen refused the FDA’s request to withdraw Tavneos from the market. Now, two researchers who participated in the original study to support the drug’s approval claim they did not know the primary endpoint was readjudicated after the study was unblinded.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
PRESS RELEASES
Upcoming Type B Statistical Methods Meeting expected to set stage for FDA to align with EMA and MHRA on use of Fall 2026 3-year overall survival data combined with biomarkers to support early market access
Highlights TempraMed signs non-binding LOI for exclusive distribution in Kuwait with Elegir Trading Kuwait represents a high-value market with significant demand for insulin, GLP-1 therapies, biologics, and other temperature-sensitive medications LOI includes minimum annual purchase commitments in Year 1 Expands TempraMed’s footprint across the Middle East and supports broader regional commercialization strategy Potential future expansion includes VIVI Med™, VIVI Epi™, and VIVI Cap Smart™ products
— Veteran Physician-Scientist Brings Over 25 Years of Pulmonary and Cardiopulmonary Clinical Development Leadership Spanning Pfizer, Gilead, and Aerovate Therapeutics —