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Results For "regulatory"

1533 News Found

Supriya Lifescience’s Ambernath facility receives WHO GMP certification
News | October 04, 2025

Supriya Lifescience’s Ambernath facility receives WHO GMP certification

With global certification in place, the Ambernath site expands Supriya’s footprint beyond APIs into high-margin formulations


AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer
Drug Approval | October 01, 2025

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
News | September 26, 2025

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
News | September 25, 2025

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
News | September 24, 2025

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
News | September 24, 2025

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'
News | September 24, 2025

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
Drug Approval | September 24, 2025

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