Feliza Mirasol

mAbxience and Sandoz are targeting a $5.7 billion market with a proposed emicizumab biosimilar for hemophilia A.

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.

Dualitas will screen over 300,000 bispecific combinations for Roche, backing a deal worth up to $1 billion in immunology research.

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.

Regulatory approvals, trial data, and major licensing deals in 2026 are accelerating subcutaneous biologics, cutting patient burden and reshaping biopharma strategy.

Today’s biopharma news highlights GSK’s myeloma strategy, Insilico’s AI longevity research, and innovations that may improve future treatment outcomes.

Insilico's Longevity Vaccines use circular mRNA to arm T cells against aging's earliest culprit cells, starting with immune rejuvenation.

GSK's new trispecific TCE targets 2 tumor antigens plus T cells, aiming to improve on the tolerability of current myeloma therapies.

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

Cellectis is pivoting to in vivo gene editing to advancing its .HEAL-101 and .HEAL-201 candidates for lipid disorders while exiting its CAR T programs.

With 15 patients now dosed in its pivotal EMERALD trial, Resolution will build on the 70% 4-year transplant-free survival seen with RTX001 in earlier data.

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

BIIE CEO Dr Stephen Wilson explains why Basel's condensed innovation ecosystem was chosen for the institute’s translational research mission.

Biora's BioJet capsule aims to deliver adalimumab without a needle, entering human testing after hitting 51.3% preclinical bioavailability.

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.

Del-desiran missed its primary endpoint in a phase 3 DM1 trial, though secondary measures showed signs of clinical activity.

BrainChild Bio's BCB-276 extended survival to 19.8 months from diagnosis in phase 1, backing its $116 million-funded pivotal DIPG trial.

Moonwalk's $70 million new funding advances MW101, an adipose-targeted siRNA aiming to cut fat while preserving muscle in obesity patients.

9MW1911 cut severe COPD exacerbations by up to 100% at the highest dose, supporting Mabwell's push toward phase 3 development.

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

GSK's up to $1.3 billion deal centers on HUTCHMED's HMPL-A830, which pairs a KRAS inhibitor with an EGFR antibody.

Apazunersen missed its primary endpoint in a phase 3 Angelman syndrome trial, meaning that patient population remains without an approved treatment option.

Here's what you need to know about how stability programs assess potency and purity in complex biologics, like bispecific antibodies, under ICH Q5C and FDA guidance.

NewBiologix's Xcell platform aims to replace costly transfection with stable cell lines for Synastra's high-dose DMD gene therapy.

Teva's TEV '408 blocked gluten-induced gut damage in a phase 2a trial, supporting its use for celiac disease, which has no approved drug treatment.