MAINZ, Germany, and ROCKVILLE, Md. — BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to gotistobart (also known as BNT316 or ONC-392) for the treatment of squamous NSCLC, an aggressive subtype of lung cancer with limited therapeutic options in...
treatment News
MAINZ, Germany – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to BNT113, an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive (“HPV16+”) head and neck squamous cell carcinoma...
VANCOUVER, BC – BioNxt Solutions Inc. is pleased to report that the comparative pharmacokinetic (PK) study for its oral dissolvable film (ODF) based proprietary Cladribine product for the treatment of Multiple Sclerosis (MS) has been completed. Results will be reported by the Company when available. The PK study closely follows...
PARIS – The European Medicines Agency has issued a marketing authorisation for OZAWADE™ (pitolisant), indicated in the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea in adults. OZAWADE™ is indicated to improve wakefulness and reduce EDS in adult patients suffering from obstructive sleep apnoea (OSA) whose EDS...
Paris — The European Medicines Agency has just granted an extension of the indication for the marketing authorisation for WAKIX® (pitolisant), which is now indicated for the treatment of narcolepsy in children from the age of 6 years, with or without cataplexy. Narcolepsy is a rare disease, which originates in...
Washington, DC – In 2023, cell and gene therapy saw an unprecedented surge with seven FDA approvals, and this year, an even greater number of these treatments could reach the market. So far in 2024, the regulator has given the green light to three new CGTs, and at least seven...
Washington, DC – The March approval of ITF Therapeutics’ Duvyzat marked the third new FDA-approved treatment in 10 months for Duchenne muscular dystrophy (DMD), a genetic disorder that causes progressive muscle weakness and degeneration. In June 2023, the regulator greenlit Sarepta’s Elevidys as the first-ever gene therapy for DMD. That...
Tosse, France – After decades of limited progress—owing to the difficulty of treating the disease and resultant market risk—glioblastoma research is entering a new phase spurred by smarter trials, targeted funding and renewed interest from companies like Merck and Jazz Pharmaceuticals. Glioblastoma, a deadly brain cancer, is notoriously difficult to...
Toronto, Canada – After a demoralizing period punctuated by the withdrawal of one of the few marketed therapies for ALS, investment in new biotechs, state-backed collaborative initiatives and buzz at BIO2025 suggest a new day in drug development for one of medicine’s most intractable diseases. The past couple of years...
Basel, Switzerland – Novartis on Saturday posted two promising Phase III readouts in rare kidney diseases, setting the pharma up for two potential approvals in the space. The company presented these data at the European Renal Association Congress over the weekend. Results from the Phase III ALIGN study showed that...