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FDA accelerated approval decision on Alzheimer’s drug likely to come soon

According to Biogen and Eisai, the accelerated approval decision for their Alzheimer’s drug could be made in early January by the FDA.

Ferring receives FDA approval for bladder cancer treatment after prior rejection

Ferring Pharmaceuticals has finally gotten FDA approval for its gene therapy medication Adstiladrin, a therapy used to treat bladder cancer patients. The...

Fentanyl’s dangerous effects potentially reversible by new compound

The devastation by fentanyl is reflected in the provisional statistics from the CDC (Centers for Disease Control and Prevention). According to the...

Serious adverse events result in Magenta stopping leukemia trial’s high-dose group

A serious adverse event occurred in the phase 1/2 trial of Magenta Therapeutics’ leukemia medicine which resulted in the company having to...

In latest developments, HistoSonics sees greater funding and board addition

HistoSonics, a private medical device company, is in the process of developing a non-invasive platform with the aid of histotripsy to prepare...

FDA Pushes Back Lynparza Decision to March

The U.S. Food and Drug Administration (FDA) has postponed making a decision on Lynparza for metastatic castration-resistant prostate cancer (mCRPC), which is...

FDA partial hold stands as Avidity shows evidence of the first targeting RNA into muscle

Avidity Biosciences has hinted that the latest phase 1/2 data of the first targeted delivery of RNA into muscle has been successful....

Cytokinetics Set to Make Its Case For Omecamtiv Mecarbil to FDA

Cytokinetics is set to present the benefits of omecamtiv mecarbil - its heart failure drug - to the FDA's advisory committee. However,...

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

Amgen’s KRAS drug gets early FDA approval for lung cancer with specific mutation

On Friday, the United States FDA (Food and Drug Administration) has authorized a medication of Amgen Biopharmaceutical in patients with NSCLC
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