Tag: FDA approval process
Needle-Free Nasal Spray FDA-Approved for Anaphylaxis Treatment
The Food and Drug Administration recently gave its approval for ARS Pharmaceuticals' needle-free nasal spray to be used as an emergency treatment for severe allergic reactions, also known as anaphylaxis. This nasal spray, named...
New Hope for Endometrial Cancer Patients with FDA-Approved Immunotherapy
The U.S. Food and Drug Administration (FDA) recently approved a new drug for certain adult patients with endometrial cancer. The drug, called Jemperli (dostarlimab-gxly), is an immunotherapy-based drug made by British pharmaceutical company GSK....
FDA Rejects MDMA and Nasal Spray for Allergic Reactions: Pharmalittle Update
Good morning everyone, hope you had a restful weekend and are ready to tackle the new week ahead. As we sip on some refreshing blueberry cobbler, let's dive into some interesting updates. The U.S....
FDA Urged to Withdraw Approval of Over 400 Tainted Medicines
The FDA recently discovered that a testing facility in India submitted fraudulent data for over 400 drugs, most of which are generics. Despite this, the agency has allowed these drugs to remain on the...
FDA Requires Further Research Before Approving MDMA Therapy
The Food and Drug Administration (FDA) has made a decision regarding the approval of MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD). The FDA has declined to approve this therapy, stating that...
FDA Requests Further Research before Approving MDMA Therapy
The Food and Drug Administration (FDA) recently declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder (PTSD), citing insufficient data to support its use. The FDA requested additional clinical trials to...
FDA Approves Needle-Free Nasal Spray for Anaphylaxis Treatment
The Food and Drug Administration recently approved a new needle-free nasal spray from ARS Pharmaceuticals for the treatment of severe allergic reactions, including anaphylaxis. The spray, called Neffy, offers an alternative to traditional autoinjectors...