Quality Systems

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Articles

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

EMA Recommends Rare Blood Cancer Treatment and Seven Other Medicines

The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.

Lisata Therapeutics Announces EMA LSTA1 Orphan Drug Designation for Pancreatic Cancer Treatment

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

EMA Recommends Seven Medicines for Approval in October

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.  

EMA Recommends Multiple Myeloma Treatment

The draft guidance document discusses quality considerations for topical ophthalmic drug products.

FDA Issues Guidance for Topical Ophthalmic Drugs

Editor of Pharmaceutical Technology Europe

Janssen has requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab). 

Janssen Seeks European Approval of Extended Indication for Rybrevant

Feliza Mirasol is the science editor for 

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

Lilly Receives Complete Response Letter from FDA for Lebrikizimab

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

EC Approves Polpharma Biologics’ MS-Treating Biosimilar

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The agency will be reorganizing field force and compliance functions.

FDA Inspections Face Overhaul

Videos

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future. 

Regulatory Filings and Submissions