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Ipsen’s Sohonos (palovarotene) capsules are designed to reduce new, abnormal bone formation in soft and connective tissues in individuals with fibrodysplasia ossificans progressiva, a rare bone disease.


FDA Approves Ipsen Fibrodysplasia Ossificans Progressiva Treatment

Feliza Mirasol is the science editor for 

FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.

FDA Halts Clinical Trial Enrollment for Gilead’s Magrolimab in AML Studies

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.  

EMA Reviews Data on Paternal Exposure to Valproate

The indication for Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

Amicus Therapeutics Launches Pompe Disease Therapy in United Kingdom

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

FDA Grants Accelerated Approval to Pfizer’s Multiple Myeloma Treatment

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities

The new drug could be a powerful tool for patients suffering depressive symptoms after birth.

FDA Approves First Oral Treatment for Postpartum Depression

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.

Unpacking COVID-19 Pandemic Response

SBS-518 is a first-in-class dual sigma receptor (SR) antagonist/dopamine transporter (DAT) inhibitor in development for the treatment of stimulant use disorder (StUD).

Sparian Biosciences Awarded Five-Year NIH/NDA Grant for Development of SBS-518

The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.

Regulatory Oversight and Compliance