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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
FDA Commissioner Marty Makary called these changes “common-sense reforms” that could expedite the development of cell and gene therapies.
Aurora joins the clutch of companies linked to Nobel Prize winner and CRISPR trailblazer Jennifer Doudna.
Hair loss–focused Veradermics and cancer biotech Eikon follow the lead of Aktis Oncology, which last week announced a $318 million IPO target.
In his annual letter, Flagship Pioneering’s Noubar Afeyan lays out a choice between near-term “human-made miracles” and a reversion to the pain and suffering of past diseases due to “growing contempt” in the U.S. for the scientific method.
Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
The prevalence of serious inflammatory safety issues such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome limits the reach of these transformative cancer therapies.
After greenlighting 56 novel therapeutics in 2025, four notable applications continue to await the agency’s action after being delayed from the fourth quarter last year.
After years stuck in the “doldrums,” the biopharma sector is in a “very good place” heading into the new year, analysts told BioSpace, with both rare and chronic diseases headlining investor and R&D interest as JPM26 kicks off.
Insmed’s freshly approved lung condition drug soared past sales expectations for 2025, netting $144.6 million in its first full quarter of sales.
Roche first partnered with MediLink in January 2024, likewise for an antibody-drug conjugate for solid tumors.
Rampart Bioscience was working on a platform to deliver gene therapies without the need for viral vectors.
Pharmas will need to provide their latest stance on the Most Favored Nation drug pricing plans, while biotech finally gets a break after a few tough years.
PRESS RELEASES
- Inobrodib in combination with pomalidomide + dexamethasone (InoPd) demonstrates strong clinical efficacy and a tolerable safety profile in heavily pretreated relapsed/refractory multiple myeloma (RRMM) patients - - Observed response rates of 60-75% with inobrodib 20 mg and 30 mg cohorts result in clinical efficacy at least two-fold higher than previously published real-world data for pom-refractory, bispecific or anti-BCMA exposed patients -
Intricon completes construction of its Evolution Free Zone location, combines with Minnetronix Medical, and will fly the Forj Medical flag at its new site; equipment and workforce move into place for the grand opening
Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study design Biomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C Meeting Company reiterates end of January 2026 timeline for MAA submission