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PMD launches first personal spirometer
ALLENTOWN, Pa. — Medical device maker PMD Healthcare has launched what it calls the first personal spirometer to monitor lung function, the company said.
PMD, based in Allentown, Pa., announced the launch of the Spiro PD, which recently received approval from the Food and Drug Administration. The device is designed to enable patients with such lung diseases as asthma, chronic obstructive pulmonary disease, cystic fibrosis and lung transplants "easily and accurately" monitor lung function anytime and anywhere.
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FDA approves new administration method for Takeda cancer drug
CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new means of administering a cancer drug made by Takeda, the drug maker said.
The FDA approved injection under the skin of Velcade (bortezomib) for multiple myeloma and mantle-cell lymphoma, also known as subcutaneous injection.
Takeda said the approval was based on results of a phase-3 trial conducted on 222 patients who had not received the drug before that showed subcutaneous injection worked as well as intravenous injection.