AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)

FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available

Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease

Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs

FDA launches PreCheck program to bring drug manufacturing back to US

The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites

Richter’s FYLREVY to transform menopause care in Europe?

The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses

ALX Oncology’s evorpacept shows promise in HER2-positive breast cancer

The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy

Arctic Vision expands global reach with acquisition of MDCO Technology’s ophthalmic device business

Pfizer’s monthly obesity drug shows breakthrough weight loss in Phase 2b trial

The study tested whether PF’3944 could maintain efficacy when switching from weekly to monthly injections and remain safe and well-tolerated

Cirena launches to revolutionize long RNA production for CRISPR & gene editing

As CRISPR and prime editing applications advance, researchers increasingly rely on longer guide RNAs to boost editing efficiency and reduce off-target effects

Epigenica launches EpiFinder Analysis Service to accelerate Epigenomic research

The new service delivers end-to-end support, managing every stage of an epigenomics project