Health ❯ Pharmaceuticals ❯ Drug Development

Regulatory Affairs

FDA Clinical Trials Elevidys FDA Regulations FDA Designations Transparency FDA Approval Process Gilead Sciences Efficacy and Safety FDA Approval FDA Approvals Labeling Practices International Standards

10 ARTICLES

4mo ago

Supreme Court Clears Path for Generic 'Skinny Labels' in Unanimous Hikma Ruling

The court said routine FDA-compliant labels and ordinary marketing do not by themselves prove inducement and set a higher bar requiring clear affirmative steps to encourage patented uses.

3 ARTICLES

4mo ago

NervGen Prices $60 Million Public Offering of Shares and Warrants

6 ARTICLES

4mo ago

Immunovant Shares Surge on Strong Rheumatoid Arthritis Data for IMVT-1402

6 ARTICLES

10mo ago

Regulatory Affairs

Supreme Court Clears Path for Generic 'Skinny Labels' in Unanimous Hikma Ruling

NervGen Prices $60 Million Public Offering of Shares and Warrants

Immunovant Shares Surge on Strong Rheumatoid Arthritis Data for IMVT-1402

Telix Investors Face Jan. 9 Deadline in Securities Suit Over Drug and Manufacturing Disclosures