Generalized Myasthenia Gravis

The development of complement inhibitors has been growing rapidly over the years, and it has proved to be one of the breakthroughs in various therapeutic areas. These inhibitors act on the dysregulated complement system, a group of proteins that forms an essential part of innate immunity. This system comes into eff...

UCB announces FDA approval of ZILBRYSQ for the Treatment of Adults with Generalized Myasthenia Gravis On the 17th of October 2023, UCB (Euronext Brussels: UCB) made an announcement regarding the approval of ZILBRYSQ® (zilucoplan) by the US FDA for the management of generalized myasthenia gravis (gMG) in adult pa...

Incyte Halts Phase III Clinical Trial for Myelofibrosis  Incyte announced the termination of Phase III LIMBER-304 trial after the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC) revealed that the study is unlikely to meet the primary endpoint in the int...

Though a rare disease, generalized myasthenia gravis (gMG) still affects around 60,000 people in the US and another 100,000 in EU-5 and Japan. As per our analysis, the total diagnosed prevalent cases of gMG were approx 116K in the 7MM in 2021. These numbers are further estimated to increase by 2032. Moreover, t...

FDA Grants Fast Track Designation to VB-111 for Platinium-resistant Ovarian Cancer The FDA has given VBL Therapeutics’ VB-111 (ofranergene obadenovec), a targeted anticancer viral gene therapy, fast track designation for use as a viable therapeutic option in patients with platinum-resistant Ovarian Cancer. VB...

Biogen's Aduhelm Marketing and Approval are Under Scrutiny in New FTC and SEC Investigations Biogen can't seem to get a break when it comes to the Alzheimer's disease drug Aduhelm. Along with limited sales and a constraining Medicare coverage plan, the medicine is now facing additional scrutiny as part of a pair...

Although COVID-19 continued to dominate headlines in 2021, pharmaceutical companies did not cease developing new treatments this year. The US Food and Drug Administration maintained a rapid rate of new drug approvals this year, all while managing the urgent examination of COVID-19 tests, treatments, and vaccines un...