Replimune FDA approval talks progress as the company seeks to overcome past rejections for its melanoma therapy.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
AstraZeneca FDA delay affects camizestrant approval for breast cancer treatment, following inconclusive evidence from advisory panel.
Regenxbio Duchenne gene therapy aims for FDA approval despite side effects.
• Regenxbio seeks FDA approval for Duchenne gene therapy.
• Therapy targets rare disease affecting 1 in 3,500 boys.
• CEO optimistic despite two serious side effects.
Pierre Fabre FDA Reevaluation marks a strategic alignment for a twice-rejected cell therapy, potentially impacting the regulatory landscape.
Arvinas FDA Approval marks a significant milestone as Veppanu becomes the first of its kind breast cancer drug to reach the market.
FDA draft guidance aims to accelerate the development of personalized therapies for rare diseases, impacting over 7,000 conditions.
Roche FDA decision on Giredestrant expected by December 2023, potentially setting a new standard for breast cancer treatment.
BMS FDA Review: The FDA has accepted BMS’s protein degrader for review, potentially impacting the US market with new treatment options.
Moderna FDA review progresses for mRNA flu vaccine after a Type A meeting, impacting the US market.
COMP360 psilocybin FDA application progresses with Phase 3 data, aiming to be the first classic psychedelic approved in the U.S.