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The FDA approved Tris Pharma’s Onyda XR to treat ADHD in children who are at least 6 years old. It’s the first liquid non-stimulant ADHD
The FDA approved Amgen’s monoclonal antibody Bkemv as the first interchangeable biosimilar for Alexion’s blockbuster Soliris to treat two types of rare blood diseases, the
Sign up for free to read a limited number of articles each month. Pick what newsletters get delivered to your inbox each week. Biopharma ENDPOINTS
The FDA should require drugmakers to warn patients of potential long-term sexual side effects from a certain class of antidepressants, the consumer advocacy group Public
The European Commission on Thursday finalized rules on how it pools expertise from across the EU to assess the effectiveness of new drugs when compared
The House Energy & Commerce’s subcommittee on health heard from the directors of the FDA’s device, biologics and drug centers on Wednesday for a “check
The FDA’s top biologics chief and a former deputy commissioner on Tuesday discussed the need for regulatory flexibility for rare disease therapies and underscored the
Senate Finance Chair Ron Wyden (D-OR) is pressing Pfizer over its tax practices as part of his investigation into how large pharma companies use subsidiaries