Vanda Pharmaceuticals

Vanda Pharmaceuticals criticized the FDA for rejecting its drug tradipitant for gastroparesis, citing a 'culture of obfuscation' and delayed action. Vanda accused the FDA of failing to meet legal deadlines and denied requests for an Advisory Committee meeting. The company has consistently challenged the FDA's decisions, including suing over constitutional violations in the drug approval process.

Vanda Pharmaceuticals criticizes FDA's review process for tradipitant's NDA for gastroparesis treatment, citing lack of transparency and disregard for scientific evidence. Vanda's CEO, Mihael H. Polymeropoulos, M.D., urges FDA Commissioner Robert M. Califf to address these issues, emphasizing the need for accountability and adherence to scientific and legal standards.

Vanda Pharmaceuticals claims the FDA's review of tradipitant's New Drug Application was flawed and inadequately addressed their complaints, in a letter to Commissioner Robert Califf.

Vanda Pharmaceuticals criticized the FDA's review process of its NDA for tradipitant, citing a lack of transparency and disregard for scientific evidence. The company expressed concerns over FDA's declining Advisory Committee meetings and sought reevaluation of the agency's policies and practices.

Vanda Pharmaceuticals criticizes FDA's review process of its NDA for tradipitant, a treatment for gastroparesis, citing lack of transparency and disregard for evidence. The company's letter to FDA Commissioner Califf highlights concerns over decision-making opacity and the decline in Advisory Committee meetings, urging for policy and cultural reforms.

Vanda Pharmaceuticals criticizes FDA's review of its NDA for tradipitant, a treatment for gastroparesis, citing a lack of transparency and disregard for evidence. Vanda's letter to FDA Commissioner highlights concerns over the agency's decision-making process and lack of response to their concerns.

Vanda Pharmaceuticals criticizes FDA's handling of its NDA for tradipitant, citing a lack of transparency and disregard for evidence. The company's letter to FDA Commissioner highlights concerns over decision-making processes and the denial of an Advisory Committee review, urging for policy and cultural reforms within the agency.

Ultragenyx Pharmaceutical announced the European Commission's approval to expand Evkeeza's use for treating children aged six months and older with homozygous familial hypercholesterolemia (HoFH), making it the first HoFH medicine for this age group in the EU. Evkeeza, an ANGPTL3 inhibitor, was initially approved in 2021 for patients aged 12 and older, with its label expanded in 2023 to include children aged 5-11. The drug's efficacy and safety for younger patients are supported by model-based extrapolation and compassionate use data.

Vanda Pharmaceuticals Inc. received a CRL from the FDA for tradipitant's NDA for gastroparesis treatment, citing insufficient evidence despite Vanda's submission of two placebo-controlled studies and real-world data. The FDA's delay and refusal to convene an expert advisory committee have been criticized. Vanda remains committed to pursuing approval and supporting patients through an expanded access program.