Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
The SPAC and Brains Bioceutical signed a definitive agreement on 5 November 2026, implying a pre-money equity value of about $750 million, with completion subject to closing conditions.
The company finished enrolling 169 evaluable patients in NANOPULSE-AF about three months early and reported Q3 2026 cash of $189.2 million.
The shoulder-focused medtech company reported $16.2 million in Q3 net revenue and flagged a new 510(k) clearance, first InSet Go cases, a patent settlement and a distribution partnership.
The single-cell and spatial biology company reported 1% third-quarter revenue growth to $150.7 million and a narrower net loss, while launching a new cloud analysis platform.
Egetis Therapeutics' board has unanimously recommended ANI Pharmaceuticals' SEK 11.25-per-share bid, weeks after the US approval of EMCITATE for MCT8 deficiency.
Elutia says a GLP rabbit study of its antibiotic-coated biologic matrix met its endpoints, with no viable MRSA or E. coli recovered, and it plans a Q4 2026 FDA submission.
The protein-sequencing company reported a $22.3 million quarterly net loss, opened Proteus pre-orders and reaffirmed its cash runway into the fourth quarter of 2028.
The medtech group reported $1.9bn in third-quarter sales as advance orders placed ahead of an ERP cutover reversed, while lifting its adjusted EPS outlook to $7.20-$7.30.
The US genetic testing company reported a narrower non-GAAP loss outlook for 2026 and projected year-end cash and investments of about $630 million.
The RECELL maker reported $26.1 million in Q3 revenue, drew the last $10 million of its Perceptive Advisors facility and removed its going-concern qualification.
The Zio maker reported third-quarter revenue of $221.6 million, completed its VitalConnect acquisition and filed FDA 510(k) applications for paediatric use of Zio Monitor.
The Barostim maker lowered its full-year outlook, pointing to weaker sales force productivity and a drawn-out dispute with a major payer, despite a second Medicare Advantage coverage policy.
The prostate ablation maker also named Richard Fabian as incoming CEO and guided to at least $25.0 million in full-year revenue.
The infusion-therapy company reported a swing to GAAP profit and a wider gross margin, and expects to finish 2026 toward the high end of its guidance.
The US drugmaker reported higher third-quarter sales and profit, but gross margin fell and epinephrine pre-filled syringe releases slowed following an FDA warning letter at its IMS facility.
The US biotech says the agency has agreed the final design of a randomised trial in previously treated chronic myeloid leukaemia, with enrolment due to start before the end of 2026.
The gene therapy and exon-skipping company lifted the low end of its net product revenue guidance by $50m and trimmed expense guidance, with two muscle-disease datasets expected this quarter.
Halozyme reported third-quarter revenue of $493.0m, with royalties of $341.0m, and raised its full-year outlook as ENHANZE partner products continued to drive growth.
ANI Pharmaceuticals has proposed buying Egetis Therapeutics at SEK 11.25 a share, gaining Emcitate, approved in the EU and US for peripheral thyrotoxicosis in MCT8 deficiency.
The US device company reported third-quarter revenue of $1.07m, held its 2026 guidance, and confirmed full enrolment in its Phase III TIGeR-PaC pancreatic cancer trial.
The rare-disease company lifted its 2026 outlook and flagged two 2027 FDA decision dates, for a KHINDIVI label expansion and the newly licensed LIBERVANT NDA.
The company's third-quarter update reports continued enrolment in both studies, cash of $202.9 million into Q2 2028, and plans to discuss expanding its ALPS programme with the FDA.
Adicet Bio reports Q3 2026 results, with ADI-212 cleared for prostate cancer and prula-cel's lupus nephritis pivotal study in start-up, alongside $100.9 million in cash.
The company ended the quarter with $272.2m in cash, while partners Novo, Roche and Bristol Myers Squibb progress late- and mid-stage trials.
CytomX Therapeutics reported third-quarter 2026 results alongside news that its EpCAM-directed masked antibody drug conjugate holds Fast Track status, with a registrational study possible in the first half of 2027.
The US cell therapy company reported about $122M in third-quarter revenue and raised its full-year outlook from $350M-$370M, citing growth in Amtagvi treatment sites.
Tectonic Therapeutic's Q3 2026 update also reports first patient dosed in the TX45 ALPINE trial, APEX topline data due by end of January 2027, and $234.7 million in cash.
Gyre Therapeutics affirmed full-year guidance after Q3 results, with an NMPA ruling on hydronidone (F351) for CHB-induced liver fibrosis possible by end-2026 or Q1 2027.
The San Diego company projects FY26 China revenue of $100.5M-$111M, a possible 2027 China launch for F351 and a mid-2027 Phase 1 start for CG923308.
vTv Therapeutics says 166 participants are randomised in its Phase 3 CATT1 trial, with topline data expected mid-2027, as the FDA grants orphan designation to HPPD for sickle cell disease.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.