Cancer therapy has undergone a drastic revolution in the past few decades with the introduction of several novel therapies, like immunotherapy (active and passive), stem cell-based therapies, and nanocarrier-based therapies. These therapies have addressed the issues of conventional cancer therapy (chemotherapy or radiotherapy), like specificity and off-target effects. Further, the introduction of such treatments has improved survival and converted a terminal disease into a more manageable condition. However, many clinical, ethical, and regulatory issues are raised with such novel additions. Several effective therapies are under research but could not come to market or are delayed due to regulatory concerns for marketing approval. The scope of this review encompasses the examination of these regulatory issues and discuss their possible solutions. A practical and flexible regulatory approach, harmonized globally, could help the patients suffering from a terminal illness to lead a quality life.

Rheumatoid arthritis (RA) is a well-known chronic inflammatory disease that results in articular degradation, comorbidities, and body part functional loss. In the last two decades, the development of effective biologics and small compounds, such as Janus kinase inhibitors (Jakinibs), has significantly improved clinical outcomes. Low-molecular-weight chemicals known as jakinibs are currently used for effective treatment of RA. Jakinibs are a new class of drugs being developed to treat RA, and several of them are now in different phases of clinical trials to establish their safety and efficacy in humans. Jakinibs can be very different in their selectivity against JAK inhibitors. For an efficient therapy of RA, it is critical to fully comprehend the properties of JAK inhibitors as well as their mechanism of action. Tofacitinib, Baricitinib, Upadacitinib, Peficitinib, Filgotinib, Decernotinib, Itacitinib, Ruxolitinib, and PF-06651600 are a few selective orally active Jakinibs that have entered clinical trials to treat RA. This review aims to elaborate on Jakinibs for the treatment of Rheumatoid Arthritis (RH), including their mechanism of action (MOA), efficacy and safety profiles, clinical trials of adverse effects (AEs) associated with Jakinibs and combination therapy with other DMARDs.