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The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward. 

Vinnova Supports the Formation of Nordic CCRM Hub

Grant Playter is the Assistant Editor for 

The next Cannabis Science Conference Fall meeting is soliciting a call for abstracts.

Cannabis Science Conference Fall Meeting Issues Call for Abstracts

The guidance describes FDA’s current recommendations regarding adjusting for covariates in statistical analysis of randomized clinical trials.

FDA Releases Final Guidance on Adjusting for Covariates in Randomized Clinical Trials

 Washington Editor, jillwechsler7@gmail.com.

Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.

FDA Eyes Advisory Committee Reform to Enhance Credibility

Feliza Mirasol is the science editor for 

FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.

FDA Approves Topical Gene Therapy for Treating Wounds Associated with Rare Genetic Skin Disorder

FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

FDA Approves AbbVie’s Bispecific Antibody for Treating Lymphoma

Biotech firm Lumen Bioscience has received fast track designation from FDA for its oral biologic drug candidate for treating C. difficile infection.

FDA Grants Lumen Bioscience Fast Track Designation for Oral Biologic

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

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

FDA Sends Warning Letter to Arizona Facility

Editor of Pharmaceutical Technology Europe

Waters Corporation expected to boost growth in bioanalytical characterization for new modalities with acquisition of Wyatt Technology.

Waters Set for Growth in Bioanalytical Characterization with Wyatt Acquisition

The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.

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