Astellas & Pfizer report breakthrough Phase 3 results in muscle-invasive bladder cancer

The combination also outperformed chemotherapy on another important secondary endpoint

Lupin receives EIR from USFDA for Nagpur injectable facility

The EIR was issued following an inspection of the facility from September 8 to September 16, 2025

Minghui Pharmaceutical gets FDA green light for Phase III trials of its therapy in thyroid eye disease

The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies

Ascletis Pharma reports positive Phase I results for oral IL-17 inhibitor

The randomized, double-blind, placebo-controlled single ascending dose (SAD) study evaluated safety, tolerability, pharmacokinetics, and target engagement in 46 healthy participants

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients

ImmunityBio’s ANKTIVA wins EMA nod for early EU approval in hard-to-treat bladder cancer

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease

Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide

All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed

Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial

Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%

EMA backs Eylea 8 mg for retinal vein occlusion

The positive CHMP opinion is supported by results from the Phase III QUASAR trial