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The FDA approved the expansion of Casgevy, which had previously been greenlit for patients 12 and up, into a younger pediatric population under the agency’s Commissioner’s National Priority Voucher program.
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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.
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.
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.
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Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
The U.K.’s core biotech cluster continues to produce world‑class science, but investors say limited talent mobility, uneven regional growth and tightening early‑ and mid‑stage capital are slowing the country’s ability to scale new companies.
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.
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.
Zymeworks announced a new plan to become a royalty-driven company last year, making Theravance a perfect match.