FDA gives green light to ADHD medical device

NeuroSigma’s prescription-only Monarch external Trigeminal Nerve Stimulation (eTNS) System is the first non-drug treatment for ADHD to be approved by the FDA and is indicated for patients aged 7 to 12 who are not taking a prescription ADHD medication. The device, which is approximately the size of a mobile phone, generates a low-level electrical pulse

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Janssen’s advanced or metastatic bladder cancer treatment approved by FDA

FDA has granted accelerated approval to Janssen’s erdafitinib, a treatment for adult patients with locally advanced or metastatic bladder cancer. Which enables the drug to be used to treat bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. The

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FDA approves Pfizer’s breast cancer biosimilar

US Patients will now be able to access another biosimilar version of Trastuzumab with the FDA approval of Pfizer’s Trazimera in the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Data supplied with the application supported the similarity of Trazimera to its reference

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FDA approves Merck’s new antibacterial drug applications

The FDA has accepted two new antibacterial drug applications from Merck & Co, both of which have received Priority Review. The first is for the company’s combination of relebactam, an investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL), for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible

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