Regulators sent about 100 warning letters this week to drug advertisers, including to Hims & Hers, a major online provider of ...

Outlook Therapeutics seeks FDA clarity on ONS-5010 after a complete response letter, aiming to address efficacy concerns for ...

Ultragenyx received a Complete Response Letter from the FDA regarding its UX111 therapy for Sanfilippo syndrome type A, citing manufacturing observations. Ultragenyx Pharmaceutical Inc. announced that ...

(RTTNews) - BrainStorm Cell Therapeutics Inc. (BCLI) said participating in a Type A meeting with the FDA will be an important next step towards enabling NurOwn's advancement through the regulatory ...

After doing PR for nearly four decades, I can remember the time when I would type a letter introducing myself or my employer and mail it to a newspaper editor or broadcast journalist in hopes of being ...