FDA approves expanded use of Sanofi's type 1 diabetes drug

June 12 (Reuters) - The U.S. Food and Drug Administration said on Friday it has approved the expanded use of Sanofi's type 1 ...

FDA expands Merck pneumococcal shot label to include at-risk children and teens

The U.S. FDA on Thursday approved an expanded indication for Merck & Co Inc.’s MRK Capvaxive, extending its use to children ...

AstraZeneca gets FDA label expansion for Truqap in prostate cancer

AstraZeneca (AZN) stock is in focus as the FDA approves a label expansion for its breast cancer therapy Truqap in prostate ...

FDA Approves Labeled Strength Update of TWIRLA® (levonorgestrel/ethinyl estradiol) Birth Control Patch

TWIRLA is a birth control patch for women with Body Mass Index (BMI) less than 30 kg/m 2 who can become pregnant. It contains two female hormones, a progestin called levonorgestrel, and an estrogen ...

Merck wins FDA label expansion for Welireg in kidney cancer

Merck (MRK) stock is in focus as the FDA approves a label expansion for the company's kidney cancer drug Welireg with its ...
The American Journal of Managed Care

FDA Approves Tocilizumab-bavi for CAR-T-Induced CRS, Pediatric COVID-19

Indication expansion now includes CAR‑T–associated severe or life-threatening CRS for adults and pediatric patients aged ≥2 years, supporting guideline-concordant IL‑6 receptor blockade in ...

FDA approves new sunscreen ingredient used for years in Europe and Asia

A new sunscreen ingredient used for years in Europe and Asia was approved for use in the US. The ingredient is safer than ...
Healio

FDA approves labeled strength update to Twirla

The FDA approved an update to the labeled strength of Twirla, a weekly contraceptive patch, its manufacturer announced.The ...
RAPS

FDA Releases New Accelerated Approval Labeling Guidance

A new guidance document published by the US Food and Drug Administration (FDA) is intended to clarify how drugs approved through the accelerated approval pathway should be labeled. FDA's accelerated ...
Ophthalmology Times

FDA accepts Outlook Therapeutics' resubmitted BLA for ONS-5010 (LYTENAVA)

The US Food and Drug Administration has accepted for review the Biologics License Application (BLA) for ONS-5010 (LYTENAVA) ...
RAPS

FDA Finalizes Accelerated Approval Labeling Guidance

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway. FDA's accelerated approval program allows the ...