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WHO Revised Biosimilar Guidelines: Streamlined Regulation for Improved Global Access

The WHO's 2022 revised biosimilar guidelines shift from mandatory clinical efficacy studies to a streamlined, evidence-based approach emphasizing analytical comparability and totality of evidence, aiming to reduce costs and accelerate access globally.

Streamlined R&D at Novo Nordisk: Insights from Research Chief Petersen

Novo Nordisk's research chief, Petersen, discusses how streamlined R&D processes enhance drug discovery efficiency, impacting the pharmaceutical landscape.

SELLAS Nears Key AML Data: Insights for Investors and BD Teams

SELLAS Life Sciences is on the verge of releasing critical data from its dual trials for acute myeloid leukemia, presenting significant investment opportunities.

FDA Approves IMGN-901: Breakthrough Therapy for Relapsed/Refractory AML

The FDA has granted approval for IMGN-901, marking a significant advancement in treatment options for patients with relapsed or refractory acute myeloid leukemia (AML).

DuPont Launches AmberChrom XT SL Chromatography Resins to Streamline Biopharmaceutical Manufacturing

DuPont introduces pre-slurried AmberChrom XT20 SL and XT30 SL chromatography resins to accelerate oligonucleotide and peptide purification workflows.

FDA Launches Manufacturing PreCheck Pilot Program to Streamline Drug Production Oversight

FDA's new PreCheck pilot program aims to modernize manufacturing inspections through risk-based approaches, potentially reducing regulatory burden.

FDA Approval OncoBlock: Accelerated Approval for Refractory AML

The FDA has granted accelerated approval for OncoBlock, a promising new treatment for patients with refractory acute myeloid leukemia (AML).