Vanda Pharmaceuticals Inc. (VNDA) experienced a setback in its quest for FDA approval of tradipitant for treating gastroparesis symptoms. The FDA issued a Complete Response Letter (CRL) requesting additional studies, leading to a 6.1% decline in Vanda’s share price. Despite the setback, Vanda continues to pursue approval for tradipitant, with ongoing development for motion sickness prevention.
The FDA has granted approval for Johnson & Johnson’s Rybrevant (amivantamab-vmjw) in combination with chemotherapy for treating advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations. This approval marks the third new indication for Rybrevant this year, highlighting its potential as a treatment option for patients with advanced NSCLC.
The FDA has approved Merck’s Keytruda in combination with chemotherapy for the first-line treatment of malignant pleural mesothelioma (MPM). This approval marks the first indication for Keytruda in MPM in the U.S. and is based on clinical trial data showing significant improvements in overall survival and progression-free survival compared to chemotherapy alone.
The FDA has approved AstraZeneca’s Fasenra (benralizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), a rare and serious inflammatory condition. The approval is based on positive results from a Phase 3 trial showing comparable efficacy and safety to the current standard treatment. Fasenra is now the second biologic approved for EGPA, providing a new option for patients battling this debilitating disease.
Applied Therapeutics’ stock price surged after the company received positive news from the FDA regarding its New Drug Application (NDA) review for govorestat, a potential treatment for Classic Galactosemia. The FDA has confirmed that an advisory committee meeting is no longer necessary, and the priority review of the NDA remains on track.
Apple Watch users can now track for potential sleep apnea with the new watchOS 11 update. This feature, which leverages the watch’s accelerometer to monitor movement during sleep, is available on the Apple Watch Series 9 and Ultra 2, and will be available on the Series 10 upon its release. While not a diagnostic tool, it can help users identify potential sleep apnea and encourage seeking medical advice.
Apple’s AirPods Pro 2 have received FDA clearance for use as over-the-counter (OTC) hearing aids, potentially transforming the market and increasing accessibility to hearing assistance. This move could significantly boost awareness and adoption of OTC hearing aids, as Apple’s massive user base and the popularity of its AirPods Pro 2 could normalize the use of these devices. Experts believe this will drive innovation and provide more choices for people with hearing loss.
The FDA has requested additional phase 3 trials for MDMA-assisted psychotherapy for PTSD, putting a hold on potential landmark approval. Despite this setback, Lykos Therapeutics remains committed to navigating the FDA’s requirements, while other psychedelic therapies continue to progress in clinical trials.
The FDA has cleared the first over-the-counter (OTC) hearing aid software device, allowing users to transform their Apple AirPods Pro into personalized hearing aids. This marks a significant step towards increased accessibility and affordability for those with mild to moderate hearing loss.
Rezolute, Inc. received positive news from the FDA, allowing them to resume US clinical trials for RZ358 (ersodetug), a potential treatment for hypoglycemia caused by congenital hyperinsulinism. This follows the FDA’s removal of partial clinical holds on the drug. The company anticipates enrollment of US participants in the global sunRIZE study to begin in early 2025.
