Regulatory Authority Actions

The FDA has accepted Pierre Fabre Pharmaceuticals’ resubmitted BLA for tabelecleucel, an allogeneic T-cell immunotherapy for EBV+ post-transplant lymphoproliferative disease. The FDA’s target action date is March 31, 2027.

FDA has accepted for review the biologics license application for FYB206, a proposed pembrolizumab biosimilar developed without a comparative phase 3 efficacy trial. A decision could come in the third quarter of 2027.

MT027, T-MAXIMUM's B7-H3 CAR-T therapy, earns a second FDA-cleared phase 2 trial, now testing lung and breast cancer brain metastases.

Genglycos, the gene therapy that earned the voucher, will fund new Ultragenyx therapies for other rare and ultra-rare diseases.

AbbVie's c-Met ADC Temab-A showed a 15.6% response rate in late-line colorectal cancer ahead of its 2 new FDA breakthrough designations.

Manufacturing remediation, not efficacy or safety data, is delaying US approval of Novo's h+emophilia A therapy denecimig.

Doubled drug substance capacity at Alvotech's Reykjavik, Iceland, site aims to secure steady US supply of the Humira biosimilar Simlandi.

Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.

Denosumab-adet now covers all 3 Xgeva indications, widening lower-cost treatment access for cancer patients with bone complications.

NouvSight001 isn't limited to the RPE65-mutation subset current gene therapy treats, potentially reaching more of the 1.5 million with RP worldwide.

Insulin efsitora alfa-gobe (Onswik) cuts injections from 365 to 52 a year for adults with type 2 diabetes, per its new FDA approval.

AstraZeneca's sBLA for durvalumab combined with neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer, based on the Phase 3 VOLGA trial, has a PDUFA date expected in the fourth quarter of 2026.

SOTIO Biotech's LRRC15-targeted antibody-drug conjugate SOT106 now holds both Orphan Drug and Fast Track Designations in soft tissue sarcoma and osteosarcoma. The company expects to start first-in-human testing later in 2026.

The FDA has approved a label update for Merck's Winrevair (sotatercept-csrk) incorporating Phase 3 HYPERION data, showing a 76% reduction in clinical worsening events when added to background therapy in adults diagnosed with pulmonary arterial hypertension within the past year.

FDA's new rule formally recognizes non-animal methods like organoids and AI models as valid ways to support human drug testing.

Glycomine's GLM101, an investigational liposomal mannose-1-phosphate substrate replacement therapy, has received FDA Breakthrough Therapy designation for PMM2-CDG, a rare glycosylation disorder with no approved treatments.

Biocon's Pebrilzo, a pertuzumab biosimilar for HER2-positive breast cancer, has become the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA's newly adopted tailored clinical approach, which can reduce comparative efficacy trial requirements.

Novo Nordisk reports that CagriSema outperformed tirzepatide with 12.4% weight loss versus 9.1% in a phase 3 trial in adults with type 2 diabetes.

Fayuvi scored 23.5 points higher than untreated peers on cognitive testing, backing the first-ever approval for a Sanfilippo syndrome A gene therapy.

FDA compliance officers detailed 2026 guidance updates, online drug sale enforcement, and a first-of-its-kind AI-related warning letter at the PDA/FDA Joint Regulatory Conference.

Inebilizumab (Uplizna) cut MG-ADL scores by 1.9 points versus placebo, supporting its approval in Japan for myasthenia gravis.

Lundbeck's asedebart, which blocks ACTH signaling at its source, has won FDA orphan status for endogenous Cushingsyndrome.

Satralizumab cut MOGAD relapse risk 68% in a phase 3 trial, positioning it as the first potential treatment for this rare disease.

Ersodetug missed its phase 3 primary endpoint in congenital HI, but FDA is reviewing CGM data showing 50%+ hypoglycemia reductions.

Acepodia's ACE723 delivers 2 cytotoxic payloads to GPC3-positive tumors, clearing FDA review to begin trials in liver cancer.