The status is based on preclinical data and data from an ongoing phase 1/2 study for BNT324/DB-1311; preliminary phase 1/2 clinical data showed anti-tu...
EG110A to start Phase 1b/2a clinical study in Neurogenic Detrusor Overactivity (NDO) patients NDO is a severe bladder condition affecting millions of ...
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely ac...
NMD Pharma A/S, a clinical-stage biotech company dedicated to developing novel and improved treatments for patients living with neuromuscular diseases, a...
Eisai Co., and Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Applicat...
The test uses highly sensitive PCR technology, requiring only a single nasal-swab sample to provide rapid, accurate qualitative detection and different...
Moderna's Investigational Therapeutic for Methylmalonic Acidemia (mRNA-3705) Selected by U.S. Food & Drug Administration for START Pilot Program ...
START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological p...
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo®(nivolumab) in combination with cisplatin and gemcitabine ...
– Priority Review recognizes the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options...
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma FDA Priority Review gran...
Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial inf...
The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with pa...
Atraverse Medical, a San Diego-based medical device company, announces the FDA clearance of its HOTWIRE™ radiofrequency (RF) guidewire, a novel devic...
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