Quality/GMPs

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.

Johnson & Johnson's modeling projects 18.5-year life expectancy with Tecvayli-Darzalex versus 4.9 years for standard care.

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.

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.

New data show risk-based and centralized monitoring shifts effort across roles, sites, and timelines, reshaping how sponsors plan CRA capacity needs.

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.

Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.

FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.

Sanofi's Dr Jack Prior detailed a data maturity framework for biologics manufacturing, while FDA and Gilead panelists debated risk-based AI validation.

FDA's consumer safety officer, Jason Chancey, detailed real inspection findings, such as taped gaskets and delayed retesting, behind sterile facility deficiencies.

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

Phio's PH-762 posted a 70% response rate in skin cancer, supporting its FDA briefing package for a planned phase 2b trial.

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.

HHS announced four senior FDA leadership selections, including Karim Mikhail as permanent Director of the Center for Biologics Evaluation and Research and Michael Davis as Director of the Center for Drug Evaluation and Research, capping more than a year of turnover at both centers.

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

Medicus Pharma secured worldwide rights to PF-08046031 (CD228V), an antibody-drug conjugate targeting melanotransferrin that Pfizer discontinued earlier this year following its $43 billion Seagen acquisition, in a co-development and license agreement that could pay Pfizer more than $1 billion in milestones.

GMP cleanroom differential pressure control prevents FDA 483 citations and contamination failures through HVAC design and validation.

uniQure submitted a Biologics License Application to the FDA and a Marketing Authorisation Application to the UK's MHRA for ifezuntirgene inilparvovec (AMT-130), an AAV5 gene therapy for Huntington's disease, based on three-year Phase I/II data — a potential first disease-modifying treatment for a condition with no approved therapies that slow progression.