Healthcare ❯ Pharmaceuticals

Regulatory Affairs

FDA FDA Approvals Drug Approval FDA Approval FDA Guidelines Product Launches Market Access Investment Strategies Clinical Research FDA Designations FDA Approval Process FDA Submissions

Capricor Faces Multiple Securities Suits After FDA Flags Unapproved Changes to Trial Analysis

FDA classification of Capricor’s resubmission as a major amendment has moved the review deadline to Nov. 22, 2026.

Oral GLP‑1s Reshape Obesity Market as Approvals, Policy Talks and M&A Accelerate Growth

AbbVie Tops Q1 and Raises 2026 Outlook as Skyrizi and Rinvoq Offset Humira Decline

Krystal Biotech Posts Strong Q4 as VYJUVEK Hits $107 Million, Pivots 2026 Growth to Ex‑U.S. Markets

AbbVie Settlements Push U.S. Rinvoq Generics To 2037

FDA Begins Expert Review of Menopause Hormone Therapy Warnings