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FDA Approvals - Oasmia: FDA Grants Paclical(R) Orphan Drug Designation For Ovarian Cancer


Oasmia: FDA Grants Paclical(R) Orphan Drug Designation For Ovarian Cancer In The USA (Medical News Today)
Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical(R) for the treatment of ovarian cancer. Orphan Drug designation can entail additional assistance from FDA to expedite and optimize drug development and upon approval a seven year market exclusivity is granted.

Developing Alzheimer's Disease Model: AAPS And FDA Announce Appointment Of Research Fellow (Medical News Today)
The American Association of Pharmaceutical Scientists (AAPS) has announced the appointment of Demiana William Faltaos, Ph.D., to the position of Research Fellow at the Oak Ridge Institute for Science and Education (ORISE), where she will begin work this week to develop effective Alzheimer's disease-state models for a 2-year period. Dr.

Somanetics Announces New FDA 510(K) Clearance (Medical News Today)
Somanetics Corporation (Nasdaq: SMTS) announced a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the labeling for its INVOS(R) Cerebral/Somatic Oximeter. The new labeling allows a claim of improved patient outcomes after surgery when the INVOS System is used to manage therapies in patients above 2.5 kilograms (kg) at risk for reduced or absent blood flow.
 

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