Development

PharmaEssentia's ropeginterferon alfa-2b-njft (Besremi) cut ET response rates to 43% versus 6% for anagrelide, backing a first-in-decades FDA nod for a new rare blood cancer treatment.

LIlly reports that Taltz plus Zepbound helped 30.6% of psoriasis patients clear skin and lose 10%+ weight at 1 year, versus 4.4% on Taltz alone.

TSY-110 could become the first biosimilar rival to Roche's ado-trastuzumab emtansine (Kadcyla), a $2.5 billion HER2 breast cancer therapy.

DualityBio's DUP5 payload shrank tumors resistant to topoisomerase inhibitor ADCs, backing its new $1 billion-plus deal with Genentech.

Varsetatug masetecan (Varseta-M) posted a 32% response rate in colorectal cancer, backing its new FDA fast track designation.

Amgen and AstraZeneca's tezepelumab (Tezspire) eased swallowing and cut esophagus inflammation in a 368-patient trial through week 52.

Webinar Date/Time: Fri, Sep 18, 2026 11:00 AM EDT

FDA's 2025–2026 guidance changes would substantially streamline biosimilar development, including by reducing comparative efficacy and switching-study requirements. Here's what's confirmed, what industry has criticized about the existing pathway, and what's still unresolved.

Biopharma mergers and acquisitions aren’t one-size-fits-all—this FAQ breaks down how deal type shapes premium pricing, deal protection, and IND sponsorship obligations.

Vanda's single-dose antibody was shown to clear severe pustular flares within weeks and is now recognized as a priority treatment across 3 continents.

Genentech is betting up to $2.3 billion on an obesity drug designed to build muscle while cutting fat, addressing a GLP-1 side effect.

The company's first-in-class immune-boosting antibody could become the first approved treatment for a cancer with no existing options.

AbbVie's bispecific antibody posted a 90% response rate in squamous NSCLC, headlining the company's expanding lung cancer pipeline data.

Avexitide cut severe hypoglycemic events 55% in a pivotal PBH trial, positioning it to become the condition's first approved therapy.

Regeneron Pharmaceuticals' garetosmab-grts has become the first approved therapy to shrink new bone lesions in FOP, cutting them by up to 94% as it targets the disease's root biology directly.

The companies are targeting a protein on glioblastoma's treatment-resistant tumor stem cells, which could open a new path past the blood-brain barrier.

Merck and Moderna report that the personalized mRNA plus mAb cancer therapy cleared its first phase 3 hurdle, cutting recurrence risk beyond pembrolizumab alone.

Webinar Date/Time: Tue, Sep 8, 2026 11:00 AM EDT

Australia's first commercial imlifidase transplant offers a path forward for patients whose antibodies had blocked a compatible kidney.

Genprex moves its diabetes gene therapy toward the clinic, tapping a CGMP CDMO after preclinical models reversed hyperglycemia in mice.

Outsourced cell and gene therapy manufacturing is set to grow nearly 6-fold by 2035 as biotech pipelines outpace in-house capacity.

The independent data monitoring committee's finding leaves clinicians without a new option for PD-L1-low NSCLC, a population historically underserved by current immunotherapies.

IASO Bio adds a fratricide-resistant CAR-T platform to its pipeline, aiming to speed novel T-cell malignancy therapies to patients.

Spevatamig's fast track status targets a cancer where 5-year survival is under 20%, pairing a novel mechanism with pembrolizumab.

Fresh $175 million in funding follows Silence's 88% response rate in its divesiran polycythemia vera trials, positioning the company for a planned 2027 phase 3 push.