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Apitoria Pharma receives 3 observations from USFDA for Unit-V
Drug Approval | December 12, 2025

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines


GSK’s experimental lung cancer drug gains FDA orphan drug status
Drug Approval | December 12, 2025

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization


$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing
Biopharma | December 12, 2025

$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing

The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification


OTR Therapeutics and Zealand Pharma join forces to target metabolic diseases
R&D | December 12, 2025

OTR Therapeutics and Zealand Pharma join forces to target metabolic diseases

The companies aim to expand treatment options for millions living with metabolic disorders


Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain
News | December 12, 2025

Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain

This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets


Granules Life Sciences facility receives EIR from USFDA
News | December 12, 2025

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements


Teva files FDA application for once-monthly schizophrenia injection
Drug Approval | December 11, 2025

Teva files FDA application for once-monthly schizophrenia injection

The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time


Lilly drug cuts risk of disease progression or death by 80% in trial
Clinical Trials | December 11, 2025

Lilly drug cuts risk of disease progression or death by 80% in trial

The company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study


BioNTech and Bristol Myers Squibb report punchy early results for experimental TNBC therapy
Clinical Trials | December 11, 2025

BioNTech and Bristol Myers Squibb report punchy early results for experimental TNBC therapy

The Phase 2 study tested two dose levels of pumitamig alongside four standard chemotherapy regimens across first


Bristol Myers Squibb unveils breakthrough Lymphoma data
News | December 11, 2025

Bristol Myers Squibb unveils breakthrough Lymphoma data

Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas