FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.
FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility in Indianapolis, IN.
FDA closes a potential enforcement action against Whoop Inc., reversing an earlier regulatory position that raised questions about whether the company...
Drug company executives recommend ways FDA could increase the use of real-world evidence in regulatory decisions.
HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting more clinical trials...
Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sngl), the first gene ...
A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that first receive exped...
