Selumetinib gets the U.S. Breakthrough Therapy Designation

Selumetinib- an investigational drug, for the treatment of pediatric patients aged three years and above suffering from symptomatic and/or progressive, inoperable neurofibromatosis type 1 (NF1), plexiform neurofibromas (PN)- a rare genetic condition, has been granted the Breakthrough Therapy Designation (BTD) from the U.S. FDA. Selumetinib is a MEK- ½ inhibitor jointly developed by AstraZeneca and Merck has shown promising improvements and proven to be of clinical significance.

FDA approves the first drug for a type of inflammatory arthritis

In the very first, the U.S. FDA has approved Cimzia (certolizumab pegol) injection for treating a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. The approval will benefit the patients suffering from nr-axSpA fulfilling their unmet medical needs.

Apexigen, BMS reports positive results for I-O therapy to treat Pancreatic Cancer

Apexigen lead Immuno-oncology drug candidate, APX005M, further rolled it out into clinical trials after its splendid performance at the annual American Association for Cancer Research (AACR) meeting in Atlanta. The combination of APX005M-a CD40-activating antibody and PD-1 inhibitor Opdivo developed by Bristol-Myers Squibb’s along with chemotherapy are designed in a specialized way to target and fight cancer in patients with advanced pancreatic cancer.

Green signal to the Merck KGaA’s drug Mavenclad

The U.S. FDA has given its nod for the use of Mavenclad (cladribine)- a new oral treatment, to treat relapsing forms of Multiple Sclerosis including relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Although because of the associated risks it has been approved only for those patients who fail to respond to other alternative drugs for MS. But Mavenclad isn’t the only candidate standing. For the same indication NovartisMayzent, also got approved not more than a week ago.