NSCLC

May 31, 2022

Bristol-Myers Squibb’s Opdivo Gets FDA Approval for Esophageal Cancer The FDA has approved two combination drug regimens based on Bristol-Myers Squibb’s PD-1 inhibitor Opdivo for previously untreated advanced Esophageal Cancer, encroaching on the territory belonging to Merck & Co’s rival Keytruda. The latest...

Mar 29, 2022

Sanofi’s Rare Disease Drug Xenpozyme Wins World’s First Approval in Japan Sanofi’s Xenpozyme, also known as olipudase alfa, the world's first therapy for the rare disease Niemann-Pick type A/B and B, has been approved for the treatment of children and adults with non-CNS manifestations of Acid Sphingomyelinase D...

Mar 22, 2022

NHS Grants Fast Track Access to Takeda’s Exkivity Takeda has secured UK approval for its lung cancer therapy Exkivity, with an NHS access deal that could see it prescribed to patients within the next few weeks. The Medicines and Healthcare products Regulatory Agency has granted conditional marketing authorisa...

Feb 15, 2022

Pfizer and Lilly's JAK Inhibitors Safety Concerns Prompt Europe to Investigate the Drug Class The risk of heart problems associated with the use of JAK inhibitors has called the entire drug class into question. In September, the FDA announced that it would require safety warnings for drugs such as Pfizer's Xelja...

Jan 14, 2022

The innovation in the oncology drug pipeline has resulted in a record number of FDA and EU approvals in recent years, as investigators and sponsors seek new and targeted treatments for individuals diagnosed with different types of cancers each year. In 2022, regulators will continue to evaluate new oncology therapi...

Jan 11, 2022

Noxxon continues enrolment in a glioblastoma therapy trial Noxxon Pharma continues subject enrolment in the GLORIA clinical trial of NOX-A12 in brain cancer (glioblastoma) patients. The move comes after the Data Safety Monitoring Board (DSMB) evaluated safety results from the preliminary four-week treatment with...

Jan 05, 2022

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...

Dec 21, 2021

Edwards secures FDA approval for Sapien 3 with Alterra Prestent for Transcatheter Pulmonic Valve Replacement Edwards Lifesciences declared to receive approval from the U.S. Food and Drug Administration (FDA) to use the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra...

Dec 06, 2021

T-cell immunoreceptor with Ig and ITIM domains (TIGIT) is a relatively new immunological checkpoint that has been studied as a potential immunotherapeutic target. TIGIT is a transmembrane glycoprotein receptor containing an Ig-like V-type domain in its cytoplasmic domain and an ITIM in its extracellular domain. It'...

Nov 01, 2021

Progress is driven by innovation. When it comes to developing novel medications and therapeutic biological products, the FDA's Center for Drug Evaluation and Research (CDER) assists the pharmaceutical sector at every stage of the process. CDER offers scientific and regulatory assistance needed to bring innovative m...