FDA

All articles by FDA

FDA to loosen blood donation restrictions for gay, bisexual men: Report
FDA to loosen blood donation restrictions for gay, bisexual men: Report
Jack O'Brien
November 30, 2022
10:37 am

Since the 1980s, the federal health agency has banned men who have sex with men from donating blood.

FDA Commissioner Robert Califf plans to keep tweeting amid Elon Musk upheaval
FDA Commissioner Robert Califf plans to keep tweeting amid Elon Musk upheaval
Lecia Bushak
November 1, 2022
2:40 pm

In a Twitter thread, Califf said it was important for the FDA to continue using the site and stand up against the platform’s potential threats.

Online startups are prescribing ketamine: Why psychiatrists are worried
Online startups are prescribing ketamine: Why psychiatrists are worried
Marc Iskowitz
October 31, 2022
2:24 pm

Online startups have fueled the rise of at-home depression treatments like ketamine. However, unsupervised use of the drug for serious mental health conditions raises safety concerns.

Amylyx ALS drug Relyvrio wins FDA nod, but price raises eyebrows
Amylyx ALS drug Relyvrio wins FDA nod, but price raises eyebrows
Marc Iskowitz
September 30, 2022
3:53 pm

On a call with analysts Friday morning, the company defended the $158,000 price tag and carved out some wiggle room on an earlier withdrawal pledge.

Long-term safety remains a question for Biogen-Eisai’s lecanemab
Long-term safety remains a question for Biogen-Eisai’s lecanemab
Marc Iskowitz
September 30, 2022
10:48 am

The monoclonal antibody produced about the same clinical effect as Aduhelm in a phase 3 trial, yet is being hailed as the next approvable treatment for Alzheimer’s disease. What could go wrong?

FDA hires new vaccine director as fall ‘booster-for-all’ campaign rolls out
FDA hires new vaccine director as fall ‘booster-for-all’ campaign rolls out
Lecia Bushak
September 16, 2022
3:25 pm

David Kaslow will replace Marion Gruber and Philip Krause, who both left the agency last year in opposition to its booster shot strategy.

FDA said to be lining up approval of Amylyx’s ALS drug
FDA said to be lining up approval of Amylyx’s ALS drug
Marc Iskowitz
September 13, 2022
9:34 am

After adcomm’s unprecedented about-face, drug candidate sees path to blockbuster status.

NIH launches monkeypox clinical trial to boost vaccine supply by ‘dose sparing’
NIH launches monkeypox clinical trial to boost vaccine supply by ‘dose sparing’
Lecia Bushak
August 22, 2022
2:48 pm

The study will test a new pathway for administering the monkeypox vaccine using one-fifth of a regular dose.

FDA to allow some OTC hearing aid sales
FDA to allow some OTC hearing aid sales
Marc Iskowitz
August 17, 2022
9:38 am

They could be in stores by mid-October, officials said.

FDA approvals slow. Is it a momentary malaise?
FDA approvals slow. Is it a momentary malaise?
Marc Iskowitz
August 11, 2022
3:08 pm

A first-half slowdown in drug approvals was blamed for at least one earnings miss. But despite a softening financial outlook, it’s a far cry from the ‘pharmageddon’ days of 2008.

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