News

Two boys died after a gene therapy. This family won’t give up hope.
The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients died, the drug’s manufacturer halted dosing under pressure from the FDA.
Armistice Capital, RTW Investments, and Wellington Management Build Stakes in Rare Disease Therapeutics Sector
Institutional investors including Armistice Capital, RTW Investments, and Wellington Management have increased their exposure ...
US FDA extends review of Bayer's menopause relief drug
The U.S. Food and Drug Administration has extended its review of Bayer's experimental menopause relief drug, the German company said on Friday.
EU Regulator Green Lights an Injectable HIV Drug That Could Help Stop Transmission
LONDON (AP) — The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing ...
BioPharma Dive18h
FDA delays approval decision for Bayer menopause therapy
The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...
Becker's Hospital Review23h
10 spine innovations earning FDA nods
From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.
‘I was skinned alive’: Patients say cosmetic surgery chains left them disfigured
A joint investigation by KFF Health News and NBC News found that cosmetic surgery chains have been the target of scores of ...
ClickOnDetroit21h
EU regulator approves injectable HIV drug that experts say could help stop transmission
LONDON – The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, ...