GSK GSK

Ionis Hibsago (bepirovirsen) receives FDA approval for chronic HBV

The FDA approved bepirovirsen (Hibsago) injection in combination with existing antiviral therapy for chronic hepatitis B in certain adults without cirrhosis. This marks the first approval of its kind for this indication.

GSK Jemperli (dostarlimab-gxly) FDA approved for MSI-H/dMMR locally advanced rectal cancer

FDA granted accelerated approval to Jemperli monotherapy for adults with stage II/III MSI-H/dMMR locally advanced rectal cancer based on AZUR-1 phase 2 data showing 68% cCR12 by investigator assessment. This is the first approved immunotherapy for this indication, potentially allowing patients to avoid chemotherapy, radiation and surgery. Continued approval contingent on confirmatory trial data.

Shingrix · NCT06569823 registry update

primary_completion: 2027-11 → 2027-06; completion: 2031-11 → 2027-06

GSK partners with Viola Davis on "Shingles, actually" education campaign

GSK launched a disease-education partnership with Viola Davis and other influencers to raise awareness of shingles risk in adults 50+ and encourage conversations with doctors about prevention. The campaign highlights Viola Davis's personal shingles experience but does not announce new clinical, regulatory or commercial milestones for any GSK vaccine.

AN2 Therapeutics Extends Gates Foundation Funding for GSK TB LeuRS Collaboration

The Gates Foundation extended funding to AN2 Therapeutics to support its ongoing research collaboration with GSK on boron-based LeuRS inhibitors for tuberculosis. This builds on prior work validating LeuRS as a target (shared with epetraborole and ganfeborole). No new clinical milestones, regulatory filings, or trial data are disclosed.

Spero/GSK: Utebzi (tebipenem pivoxil) FDA-approved for cUTIs

FDA approved Utebzi (tebipenem pivoxil), the first and only oral carbapenem antibiotic in the US, for adults with complicated urinary tract infections who have limited or no alternative oral options. The approval is based on the PIVOT-PO Phase 3 trial showing non-inferiority to IV imipenem-cilastatin. GSK holds exclusive global rights (excluding select Asian territories) and plans US launch by end of 2026.

Spero Therapeutics, Inc. · FDA approves Utebzi (tebipenem pivoxil)

FDA lists Utebzi (tebipenem pivoxil) as novel drug approval #22 of 2026 on 2026-06-17: To treat complicated urinary tract infections, including pyelonephritis, caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options

Roche VENTANA MMR RxDx Panel receives IVDR label expansion

The VENTANA MMR RxDx Panel companion diagnostic has been granted IVDR approval in the EU for expanded use across five cancer types and six therapy indications. The label now covers KEYTRUDA (pembrolizumab), IMFINZI (durvalumab), IMFINZI+LYNPARZA, and JEMPERLI (dostarlimab) for dMMR or pMMR tumors in colorectal, endometrial, gastric, small intestine, and biliary cancers.

Spero: tebipenem HBr NDA PDUFA set for June 18, 2026

FDA set the PDUFA date for the tebipenem HBr NDA to June 18, 2026. The NDA was submitted by GSK in December 2025 and is supported by the Phase 3 PIVOT-PO trial, which was stopped early for efficacy in May 2025.

Ionis/GSK: bepirovirsen NDA accepted for Priority Review, PDUFA Oct 26 2026

FDA has accepted GSK’s NDA for bepirovirsen and granted Priority Review and Breakthrough Therapy Designation. The agency set a PDUFA target action date of October 26, 2026, shortening the review clock to six months.

Spero: GSK announces FDA sets tebipenem HBr PDUFA date June 18, 2026

GSK resubmitted the tebipenem HBr NDA to FDA in December 2025. In February 2026, GSK announced the FDA set the PDUFA target action date as June 18, 2026. The NDA is supported by the Phase 3 PIVOT-PO trial that was stopped early for efficacy in May 2025.

Ionis: bepirovirsen Phase 3 B-Well 1 & 2 topline positive in CHB

Positive topline results from the pivotal Phase 3 B-Well 1 and B-Well 2 studies of bepirovirsen in chronic hepatitis B were announced. The data showed a statistically significant and clinically meaningful functional cure rate, triggering planned worldwide regulatory submissions in 2026.

Spero: GSK files NDA resubmission for tebipenem HBr in cUTI

GSK filed an NDA resubmission for tebipenem HBr with the FDA. The filing triggers a $25 million milestone payment to Spero, expected in Q1 2026. The NDA covers the treatment of complicated urinary tract infections including pyelonephritis.