Drug Approval | January 12, 2026
FDA rejects Vanda’s jet lag drug in current form
Vanda strongly disputes the FDA’s reasoning
Vanda strongly disputes the FDA’s reasoning
India should explore Sustainability-Linked Incentives (SLI) targeting innovations in the 12 principles of green chemistry
India’s pharmaceutical sector stands at a pivotal inflection point
The approval is supported by data from three pivotal clinical trials
The filing clears the regulatory path for potential first-in-human trials and marks a key advance in the company’s chronic inflammatory disease pipeline
The Phase II study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of 9MW3811 in patients with pathological scarring
The study will run across 18 sites and enroll roughly 200 patients over 24 months
Applications include detailed scientific rationale and supporting clinical evidence
Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
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