FDA grants De Novo classification to first needle-free, glucose sensor Biolinq Shine

AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer

BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma

Pi Health to deliver clinical research services for GSK’s Phase 2 oncology trial

Physician-led Pi Health has demonstrated capabilities to dramatically reduce clinical trial timelines and administrative burden, while increasing data quality

Evonik launches MaxiPure Polysorbate 80 for injectable drug formulations

Ultra-high purity surfactant for biologics and parenteral drug formulations

Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment

Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion

Alkem launches pertuzumab biosimilar ‘Pertuza’ for treatment of HER2-positive breast cancer

Alkem's Pertuza is an affordable, indigenously-developed and manufactured biosimilar of pertuzumab

Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'

Prolia is a prescription medicine used to treat osteoporosis in women

AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population

Eli Lilly to build new $6.5 billion orforglipron manufacturing facility in Texas

The new Houston site, Lilly's eighth U.S. manufacturing facility announced since 2020, will focus on domestic production of small molecule synthetic medicines

Moderna delivers Canada’s first locally manufactured mRNA vaccines

All drug substance for Moderna’s authorized Spikevax (COVID-19 mRNA vaccine) targeting the SARS-CoV-2 LP.8.1 variant is produced at the company’s facility in Laval, Quebec