https://www.biospace.com/fda FDA News: Approvals, Adcomms, Complete Response Letters and Guidances en-US Thu, 02 Jul 2026 14:54:36 GMT https://www.biospace.com/policy/biotechs-china-problem-an-issue-of-national-security-or-economic-value-for-the-us Jef Akst Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas' clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry. Thu, 02 Jul 2026 14:54:36 GMT https://www.biospace.com/policy/biotechs-china-problem-an-issue-of-national-security-or-economic-value-for-the-us https://www.biospace.com/fda/7-fda-decisions-to-watch-for-in-q3 Tristan Manalac Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year. Thu, 02 Jul 2026 13:32:11 GMT https://www.biospace.com/fda/7-fda-decisions-to-watch-for-in-q3 https://www.biospace.com/fda/vertexs-casgevy-becomes-first-approved-gene-therapy-for-young-kids-with-rare-blood-disorders Tristan Manalac 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. Thu, 02 Jul 2026 11:34:52 GMT https://www.biospace.com/fda/vertexs-casgevy-becomes-first-approved-gene-therapy-for-young-kids-with-rare-blood-disorders https://www.biospace.com/fda/orca-opens-up-treg-cell-therapy-with-fda-nod-for-allogeneic-blood-cancer-treatment Heather McKenzie The approval of Tregzi—the first regulatory greenlight for Orca Bio—was based on a Phase 3 study in which patients on the therapy were twice as likely to survive without cancer relapse and without chronic GVHD compared with conventional allogeneic transplant. Wed, 01 Jul 2026 14:21:01 GMT https://www.biospace.com/fda/orca-opens-up-treg-cell-therapy-with-fda-nod-for-allogeneic-blood-cancer-treatment https://www.biospace.com/fda/eli-lilly-and-regeneron-among-7-companies-picked-for-fda-precheck-pilot-program Nick Paul Taylor Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA. Wed, 01 Jul 2026 13:22:08 GMT https://www.biospace.com/fda/eli-lilly-and-regeneron-among-7-companies-picked-for-fda-precheck-pilot-program https://www.biospace.com/fda/sarepta-secures-early-2027-fda-decision-for-duchenne-drugs-pushing-past-confirmatory-fail Tristan Manalac Sarepta Therapeutics is seeking to convert the accelerated approval of its therapeutic exon-skippers for Duchenne muscular dystrophy to full despite the drugs’ failure to improve motor function in a confirmatory trial. Wed, 01 Jul 2026 11:56:42 GMT https://www.biospace.com/fda/sarepta-secures-early-2027-fda-decision-for-duchenne-drugs-pushing-past-confirmatory-fail https://www.biospace.com/drug-development/sentiment-at-bio-soars-as-fda-resets-dealmaking-evolves-amgens-tavneos-in-hot-water Jef Akst Heather McKenzie Annalee Armstrong Gabrielle Masson 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. Wed, 01 Jul 2026 10:40:33 GMT https://www.biospace.com/drug-development/sentiment-at-bio-soars-as-fda-resets-dealmaking-evolves-amgens-tavneos-in-hot-water https://www.biospace.com/fda/fda-rejects-unicycive-and-sobi-filings-over-contract-manufacturing-deficiencies Nick Paul Taylor Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners. Tue, 30 Jun 2026 14:53:16 GMT https://www.biospace.com/fda/fda-rejects-unicycive-and-sobi-filings-over-contract-manufacturing-deficiencies https://www.biospace.com/fda/fdas-cell-and-gene-therapy-head-steps-down-after-1-year Michael Gibney Vijay Kumar, acting director of CBER’s Office of Therapeutic Products, will leave his role at a tumultuous time for the FDA. Tue, 30 Jun 2026 14:21:23 GMT https://www.biospace.com/fda/fdas-cell-and-gene-therapy-head-steps-down-after-1-year https://www.biospace.com/fda/fda-hits-praxis-with-3-month-delay-for-epilepsy-drug-verdict Tristan Manalac The delay is largely “benign” for Praxis Precision Medicines, according to Jefferies, which emphasized that the FDA did not flag safety or manufacturing issues. Tue, 30 Jun 2026 11:52:59 GMT https://www.biospace.com/fda/fda-hits-praxis-with-3-month-delay-for-epilepsy-drug-verdict