FDA Finally Moves to Scrutinize Specialized Health Screenings
The Food and Drug Administration issued a rule on Monday that brings new scrutiny to a vast array of critical lab tests, including some popular prenatal genetic screenings, that reach patients without any federal agency checking to ensure they work the way their makers claim.

FDA Clears IND of PRAME TCR-IL-15 NK Program for R/R Myeloid Malignancies
The FDA issued a ‘safe to proceed’ for the investigational new drug application for PRAME TCR/IL-15 NK for relapsed or refractory myeloid malignancies.

New FDA Guidance Looks to Improve Clinical Trial Enrollment and Diversity
Recently published guidelines from the FDA aim to expand eligibility criteria in clinical trials with recommendations for laboratory values, washout periods, and patient performance status.

FDA defends lab test rule, as critics fear industry upheaval
The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burdens could slow access to testing.

Wegovy Is Available Again After Shortages, FDA Says—But Supplies Are Still Limited
Some of Novo Nordisk’s popular weight loss drug Wegovy is back in stock in the U.S. after months of limited supplies, according to an update on the Food and Drug Administration’s website, though shortages are set to continue as booming demand for obesity drugs still vastly outstrips Big Pharma’s ability to ramp up production.

Prime Medicine Gets FDA Okay for First Trial of Gene Editing Technique
Prime Medicine announced Monday that the FDA has cleared a study of a drug candidate based on its prime editing platform, marking the first time the agency has greenlit the use of the genetic technology in humans.

Tisotumab Vedotin Gains Full FDA Approval for Recurrent or Metastatic Cervical Cancer
Tisotumab vedotin-tftv was granted FDA approval to treat patients with recurrent or metastatic cervical cancer with a chance of disease progression on or after chemotherapy. The decision converts tisotumab vedotin's September 2021 accelerated approval to a full approval.

FDA clears first fully autonomous AI for portable diabetic retinopathy screening
AEYE Health's clearance enables global prevention of the leading cause of blindness in the working age population by making screening accessible anywhere.

Accord BioPharma get FDA OK for Herceptin biosimilar
The product has been approved for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

FDA-approved surgical robots trend toward autonomy
A recent review published in the journal npj Digital Medicine examines the current categories of surgical robots that have been approved by the United States Food and Drug Administration (FDA) based on Levels of Autonomy in Surgical Robotics (LASR).

 

 

 

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