FDA approves first immunotherapy for recurrent respiratory papillomatosis

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters

USFDA limits use of J&J Covid-19 vaccine to certain individuals

The FDA has determined that the known and potential benefits of the vaccine for the prevention of Covid-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible

Moderna Covid-19 boosters after five-month interval: U.S. FDA

Earlier last week the U.S. FDA had also shortened the time to receive a Pfizer booster shot from six months to five months for everyone 12 and older

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research

U.S. FDA gives green light to Moderna and J&J booster doses

The authority also allowed mix and match of booster doses once the primary vaccine has been administered.

SAB Biotherapeutics nonclinical data indicates SAB-185 neutralizes Delta and Lambda SARS-CoV-2 Variants

SAB-185 is currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial