Tag: FDA approval process

news-13082024-135650

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...
news-13082024-043521

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....
news-13082024-014827

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....
news-12082024-133741

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...
news-12082024-103130

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...
news-10082024-103946

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...
news-09082024-223537

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...

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