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Pfizer Inc. said on Tuesday the company would halt enrollment in a trial for its COVID-19 antiviral drug, Paxlovid, in standard-risk patients after a study revealed the treatment was not effective in reducing symptoms in that group.

Almost a month ahead of schedule, the U.S. Food and Drug Administration has approved Alnylam Pharmaceuticals’ Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy in adults.

Amylyx Pharmaceuticals Inc.’s experimental drug for the neurodegenerative disease amyotrophic lateral sclerosis (ALS) would be more cost effective than other U.S.-approved treatments if priced around $170,000, an independent U.S. pricing watchdog said on Tuesday.

Rune Labs on Monday said the San Francisco-based startup has received clearance from the U.S. Food and Drug Administration to use the Apple Watch to monitor tremors and other common symptoms in patients with Parkinson’s disease.

Mallinckrodt plc today announced the company has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration for the investigational agent terlipressin to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function.

U.S. Food and Drug Administration staff reviewers on Sunday said Pfizer-BioNTech’s COVID-19 vaccines were effective and safe for use in children aged 6 months to 4 years.

U.S. Food and Drug Administration staff reviewers on Friday said Moderna Inc.’s COVID-19 vaccine appears safe and effective for use in children aged 6 months to 17 years old as a committee of scientists will meet next week to vote on whether to recommend the regulator authorize the vaccine in children.

Advisers to the U.S. Food and Drug Administration on Thursday voted to recommend approval of bluebird bio’s treatment for a rare neurological disorder, bringing it closer to becoming the third gene therapy to be available in the United States.

Pre-orders of vaccines for children under age five have been slow, but Biden administration senior officials say they are not alarmed and expect the pace to pick up after federal approvals later this month.

The annual meeting of the American Headache Society (AHS) is being held in Denver, Colorado from June 9-12. Here’s a look at just some of the wide-ranging research being presented.