FDA panel says new data support ‘full’ approval of Alzheimer’s drug Leqembi
By
Alicia Lasek
Jun 12, 2023
New trial data for lecanemab (Leqembi) supports traditional, or “full” federal approval, the agency’s advisers said Friday. The decision is a step toward possible expanded patient access.
FDA OKs second RSV vaccine option for older adults
By
Alicia Lasek
Jun 02, 2023
Pfizer’s Abrysvo was found to be 67% effective in preventing confirmed RSV in cases with two symptoms, and even more effective in preventing disease with three or more symptoms, clinical trial data...
Survey: U.S. neurologists would prescribe Leqembi if fully approved
By
Alicia Lasek
Apr 12, 2023
A “healthy proportion” of surveyed neurologists have already begun prescribing the treatment, and nearly all said they planned to do so if traditional FDA approval is granted.
FDA advisers support full approval of Paxlovid for at-risk older adults
By
Alicia Lasek
Mar 16, 2023
The antiviral drug Paxlovid should receive full FDA approval to treat COVID-19 in older adults at risk of severe outcomes, the advisers decided in a Thursday vote.
FDA approves new drug Leqembi to treat early Alzheimer’s disease
By
Alicia Lasek
Jan 09, 2023
The newly approved drug Leqembi (lecanemab) may slow progression of cognitive decline due to Alzheimer’s disease, trial data show. CMS says it may rethink Medicare coverage of drugs in Leqembi’s...
On eve of Alzheimer’s drug decision, Congress critiques FDA for Aduhelm review failures
By
Alicia Lasek
Jan 03, 2023
An “atypical review process and corporate greed” factored into the FDA’s approval of Alzheimer’s drug Aduhelm in 2021, congressional investigators say. They recommend sticking to protocol...
Investigators fast-track new UTI antibiotic for FDA approval
By
Alicia Lasek
Nov 07, 2022
A new oral antibiotic that targets the common causes of urinary tract infections has proven highly successful in clinical trials.
Clinical briefs for Wednesday, Aug. 17
By
Alicia Lasek
Aug 17, 2022
Makers of new class of schizophrenia drug expect to file for FDA approval … Precancerous skin lesions common among Medicare beneficiaries: study … Triple therapy halves mortality in patients with severe...
FDA authorizes 3-minute breath test to detect COVID
By
Amy Novotney
Apr 18, 2022
The Food and Drug Administration on Thursday issued an emergency use authorization for the first COVID-19 test that uses breath samples. The test, which must be done by a trained operator, can provide...
Biogen hit with class-action lawsuit involving Alzheimer’s drug Aduhelm
By
Alicia Lasek
Feb 10, 2022
The lawsuit alleges securities fraud on behalf of investors, adding to the ongoing fallout following Aduhelm’s controversial approval and Medicare’s questionable coverage proposal.