Food and Drug Administration (FDA)
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As the U.S. Food and Drug Administration begins to take aim at updating its 40-year-old draft guidance on drugs that treat major depressive disorder (MDD), three drugmakers with key business in that space are raising some concerns.
The U.S. Food and Drug Administration (FDA) cleared Cleveland-based SPR Therapeutics’ SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems for controlling pain.
The high cost of some prescription drugs has been a political target of the White House and Health and Human Services Secretary Alex Azar honed in on one potential solution that he claims his department can control – drug rebates.
The U.S. Food and Drug Administration (FDA) granted Merck & Co.’s Keytruda another approval, this one in combination with Alimta (pemetrexed) and platinum chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
H. Gilbert Welch, a health care policy scholar at Dartmouth College, reportedly plagiarized part of the contents in a 2016 New England Journal of Medicine article. The article focused on breast cancer screening and the increased likelihood of tumors being overdiagnosed.
Two weeks ago during its quarterly report, Novo Nordisk pointed to positive results in four of 10 Phase IIIa trials with oral semaglutide. This morning, the company revealed that the drug hit the mark in the reduction of blood sugar levels and weight in adults with type 2 diabetes.
Swiss Pharma giant Roche expanded its presence in China with the approval of its lung cancer drug, Alecesna. Roche said the medication was approved by the China National Drug Administration under a priority review.
It’s a busy week on the U.S. Food and Drug Administration (FDA)’s calendar, although the agency got ahead of itself and approved three of the applications early. Here’s a look.
The U.S. Food and Drug Administration has done another about-face. Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA has now approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
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