Regulatory

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,...

Europe Approves Novo Nordisk’s Ozempic for Reducing Kidney Disease Risk

Danish pharmaceutical company Novo Nordisk has received approval from the European Medicines Agency (EMA) to expand the labeling of its diabetes medication Ozempic. The...

FDA Identifies Further Safety Concerns With Intercept’s Liver Drug

The Food and Drug Administration (FDA) has uncovered additional safety concerns related to a medication used to treat a rare liver disease, casting further...

J&J MedTech Gets FDA Nod for Varipulse PFA System

After the FDA approves Johnson & Johnson MedTech's Varipulse technology for the management of atrial fibrillation, the company will join the U.S. pulsed field...

FDA to lift hold over Novavax flu-shot program

Maryland-based biotech Novavax experienced a clinical hold on its late-stage trial of COVID-influenza and standalone flu vaccines after a severe adverse effect, in the...

Latest news

Regenxbio And Nippon Sinyaku Pen $810M Gene Therapy Agreement

Regenxbio has struck a strategic partnership valued at $810 million with Japan's Nippon Shinyaku to promote gene treatments aimed...

Sling Therapeutics Challenges Tepezza in Thyroid Eye Disease Treatment

Sling Therapeutics has achieved a milestone in the development of its oral treatment for thyroid eye disease (TED), linsitinib....

Umoja Biopharma Secures $100 Million Series C Funding for Cell Therapy Advancements

Umoja Biopharma has successfully closed a $100 million Series C funding round, marking a step forward for the company’s...

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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Novo Nordisk stakes $255 million to acquire another obesity asset

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A little boy’s tragic cardiac arrest puts Pfizer’s Phase 3 gene therapy experiment on hold

A young child with Duchenne muscular dystrophy (DMD) participating...