On May 8, 2020, the U.S. Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for the following indications:
On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
On the same day, the FDA also approved the FoundationOne CDx assay (Foundation Medicine, Inc.) as a companion diagnostic for capmatinib.
Read FDA announcement.
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On April 30, the Centers for Medicare & Medicaid Services (CMS) issued another round of sweeping regulatory waivers and rule changes aimed at further increasing access to telehealth for Medicare beneficiaries in response to the COVID-19 public health emergency. Among the announced changes, CMS is:
On May 1, 2020, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.
Daratumumab and hyaluronidase-fihj is approved for the following indications that intravenous daratumumab had previously received:
On Thursday, April 23, the U.S. House of Representatives passed the coronavirus rescue package totaling nearly $500 billion by a vote of 388-5-1. Four conservative Republicans broke with the GOP leadership to vote against the bill, referencing the impact on the federal deficit. The Senate passed the legislation unanimously by voice vote earlier this week.
The legislation would bring an immediate $321 billion in funding for the Paycheck Protection Program, the small business rescue fund that was depleted last week. The rescue package would also provide $75 billion in emergency relief for hospitals, $25 billion to ramp up coronavirus testing, and an additional $60 billion in economic disaster loans for small businesses.
The bill now goes to President Trump, who is expected the sign the legislation into law.