Changes to the Regulatory Landscape, and what they mean.
FDA
Par Health USA is recalling 22 lots of its Argatroban Injection after particulate matter — cellulose, plastic fragments and possibly stainless steel — turned up in vials of the injectable anticoagulant. It is the company's third U.S. product recall in about a month.
For Physicians
FDA
EMA’s CHMP has recommended EU approval of Rasonque (daraxonrasib), an oral pan-RAS(ON) inhibitor already available in the US since August 2026 — the first RAS-targeted therapy to reach patients with pancreatic cancer, a disease where more than 90% of tumors carry a RAS mutation. What the evidence shows, what the toxicities mean day to day, and what is and isn’t available yet.
Spotlight
Centinel Spine
FDA approval for two-level use of prodisc C Nova, announced 14 October 2026, gives the West Chester, Pennsylvania spine-device maker three cervical discs cleared for both one- and two-level replacement, three weeks after it filed for a $100 million IPO.
Drugs & Biologics
FDA
FDA has approved a supplemental application for Enspryng (satralizumab-mwge) in thyroid eye disease, making it the first treatment for the condition a patient can inject at home rather than receive by infusion — and the third FDA-approved TED therapy overall.
Drugs & Biologics
EMA & EU
The EMA's CHMP has issued a positive opinion recommending EU marketing authorisation for Revolution Medicines' Rasonque (daraxonrasib) in previously treated metastatic pancreatic cancer — the first drug to reach a full opinion through the agency's new phased-review pathway for oncology medicines.
Clearances, approvals, financings and launches — the companies getting the go-ahead.
All spotlights →Centinel Spine
FDA approval for two-level use of prodisc C Nova, announced 14 October 2026, gives the West Chester, Pennsylvania spine-device maker three cervical discs cleared for both one- and two-level replacement, three weeks after it filed for a $100 million IPO.
Ascendis Pharma ASND
The EMA’s human-medicines committee recommended EU marketing authorization for once-weekly navepegritide on 16 October 2026, pointing the Copenhagen-area biopharma toward a second regulatory region for the only drug to challenge BioMarin’s eight-year hold on achondroplasia treatment.
Marengo Therapeutics
The Cambridge, Massachusetts biotech's T-cell-activating antibody, invikafusp alfa, moves from a single-cancer Fast Track designation to any tumor mutational burden-high solid tumor — a tissue-agnostic expansion the company says is a first for its class of immunotherapy.
FDA
Ascendis Pharma
Marengo Therapeutics
Iambic Therapeutics
Soufflé Therapeutics
Leads Biolabs
Retension Pharmaceuticals
Centinel Spine
Endovascular Engineering
Vantis Vascular
The archive
296 stories and counting, each sourced to the primary record. Search by keyword, or open the archive and filter by section, agency and series.
