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

SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases

Wanbury achieves first sales invoicing and commercial shipment milestone

This achievement validates global demand and catapults Wanbury into high-growth acceleration

NATCO receives FDA's tentative approval for Erdafitinib tablets

NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration