Regulatory

FDA Approves Romvimza for Treatment of Tenosynovial Giant Cell Tumor

The U.S. Food and Drug Administration (FDA) has approved Romvimza (vimseltinib) for the treatment of tenosynovial giant cell tumor (TGCT). The drug, developed by...

FDA Approves Penmenvy Vaccine for Meningococcal Disease Prevention

The U.S. Food and Drug Administration (FDA) has approved Penmenvy, a vaccine for meningococcal groups A, B, C, W, and Y, for use in...

SpringWorks Gains FDA Green Light For Genetic Disorder Drug Gomekli

Following the recent statement by Merck KGaA that it is in advanced talks about buying SpringWorks Therapeutics, the rare illness specialist from Connecticut has...

AZ, Daiichi’s Enhertu Bags 7th FDA Green Light, First For Breast Cancer

Enhertu, the first antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, has received a seventh nod from the FDA, only 11 days after...

Merck’s HPV Vaccine Gets Green Light From China Regulator

According to a statement released by Merck, its human papillomavirus vaccination (HPV) has been authorized for male use in China. This news provides the...

FDA Lays Out Guidelines Regarding Pulse Oximeter Accuracy Across Skin Tones

To assist in ensuring that pulse oximeters function appropriately across all skin tones, the Food and Drug Administration (FDA) has released a series of...

FDA finally approves Novo Nordisk’s once-daily hemophilia medication

Novo Nordisk got a once-daily hemophilia injection cleared days before 2025. Novo reported that the FDA approved its tissue factor pathway inhibitor (TFPI) antagonist...

FDA Restricts Imports from Viatris’ India Facility Amid Compliance Concerns

The U.S. Food and Drug Administration (FDA) has imposed restrictions on the import of 11 products manufactured at Viatris’ drug production facility in Indore,...

Latest news

FDA Approves Romvimza for Treatment of Tenosynovial Giant Cell Tumor

The U.S. Food and Drug Administration (FDA) has approved Romvimza (vimseltinib) for the treatment of tenosynovial giant cell tumor...

FDA Approves Penmenvy Vaccine for Meningococcal Disease Prevention

The U.S. Food and Drug Administration (FDA) has approved Penmenvy, a vaccine for meningococcal groups A, B, C, W,...

Former Inizio Evoke Executives Launch Flex Marketing

A group of former executives from health communications firm Inizio Evoke have launched Flex Marketing, a new independent agency...

Must read

Surrounded by controversy, FDA approves Biogen’s Alzheimer’s drug Aduhelm

In the middle of the debate about the Alzheimer’s drug approval, the United States FDA has authorized Aduhelm

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Biohaven’s SMA drug fails to produce statistically significant results in a late-stage trial

A late-stage study testing the efficacy of Biohaven's taldefgrobep...