FDA OKs Tezspire for Severe Asthma
The FDA approved AstraZeneca and Amgen's medication, Tezspire, to treat severe asthma for patients aged 12 years and older.
Tag: FDA approval clearance
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FDA Approves Pradaxa to Treat VTE in Children Age 3 Months to 12 Years Old
The FDA approved Pradaxa oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days.
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FDA Approves Medication to Prevent Chemo Damage in Lung Cancer
The FDA approved the new medication Cosela for injection to decrease the damage to the immune system and bone marrow from chemotherapy administered for lung cancer.
FDA Approves ANDA for Intubation Anesthetic
The US FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, used to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
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Remdesivir First Therapeutic Approved by FDA for COVID-19
The US FDA approved the COVID-19 antiviral drug remdesivir (Veklury, Gilead Sciences) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kg.
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First Mesothelioma Therapeutic Approved in 16 Years
The FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.
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FDA Clears Vida Diagnostics Additions to Lung Imaging Solution
Vida Diagnostics Inc has received 510(k) clearance from the FDA for enhancements to its LungPrint solution.
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FDA Clearance for Capsule Monitor with Masimo Capnography
Capsule Technologies has received FDA 510(k) clearance for its Vitals Plus monitoring solution with the Masimo NomoLine ISA CO2 module.
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FDA Approves Abbreviated NDA for Sedation Drug
The FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection, which is used for patient sedation in some medical procedures.
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FDA Approves Needle Tip Tracking Technology for Regional Anesthesia
The FDA has issued 510(k) clearance to B. Braun’s Onvision, a breakthrough ultrasound guidance solution for real-time needle tip tracking, used with the Philips Xperius ultrasound system.
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FDA Approves Viltepso for Rare Duchenne Muscular Dystrophy Mutation
The FDA granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy in patients with a specific gene mutation.
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FDA Approves First Liquid Biopsy + NGS Diagnostic Test for NSCLC
The FDA has approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing technology to ID EGFR gene mutations in metastatic non-small cell lung cancer.
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FDA Approves Vitalograph’s In2itive e-Diary Spirometer
Vitalograph’s next generation In2itive e-Diary combines in-clinic spirometry, home monitoring of respiratory endpoints, and eCOA data gathering functions in a robust, handheld medical device.
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FDA Approves Tempus ALS Defibrillator and Monitor Solution from Philips
The Philips Tempus ALS combines a remote portable vital signs patient monitor (Tempus Pro), and remote professional defibrillator (Tempus LS-Manual).
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FDA Approves Triple Therapy Breztri Aerosphere for COPD
Breztri Aerosphere is a single-inhaler, fixed dose triple-combination of the ICS budesonide, the LAMA glycopyrrolate, and LABA formoterol fumarate.
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