7 recent drug, device approvals

Seven drugs and medical devices approved by the FDA in December: 

  1. Interscope's EndoRotor system — The FDA Dec. 23 authorized the marketing of the EndoRotor system to cut out and remove dead tissue for patients with walled-off pancreatic necrosis, a potentially deadly condition that can occur after an episode of severe acute pancreatitis.

  2. AstraZeneca's Tagrisso (osimertinib) — The FDA Dec. 18 approved Tagrisso as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation. 

  3. Integrum's prosthetic implant — The FDA Dec. 18 approved a prosthetic implant made by Integrum called the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system in the U.S. for adults with above-the-knee amputations and can't use a conventional socket prosthesis.

  4. Myovant Sciences' Orgovyx (relugolix) — The FDA Dec. 18 approved Orgovyx, the first oral hormone therapy for the treatment of men with advanced prostate cancer.

  5. Miach Orthopaedics' ACL implant — The FDA Dec. 16 approved the marketing of an ACL implant from Miach Orthopaedics that is intended to serve as an alternative to ACL reconstruction to treat ACL tears.

  6. Roche & Blueprint Medicines' Gavreto — The FDA Dec. 2 approved Gavreto, a drug developed by Roche and Blueprint Medicines, to treat patients 12 and older with advanced or metastatic RET-mutant thyroid tumours. The drug was already approved to treat adults with metastatic RET-positive non-small-cell lung cancer.

  7. UCLA & UCSF's Gallium 68 PSMA-11 — The FDA Dec. 1 approved Gallium 68 PSMA-11, a drug developed by the University of California Los Angeles and the University of California San Francisco, to aid in the treatment of men with prostate cancer. 

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