Regulatory News

medicine
The FDA has issued an advisory against the use of fluoroquinolone antibacterial drugs, such as Cipro or Avelox, for patients with certain respiratory or urinary tract infections.
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The new FDA deeming rule will go into effect on August 8, 2016 and will restrict the sale and marketing of these tobacco products to minors and require manufacturers to receive marketing authorization from the FDA.
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The US FDA has approved Bevespi Aerosphere inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD.
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Praxair Inc's subsidiary, Praxair Canada Inc, has received approval for the sale of its Noxivent brand of inhaled nitric oxide in Canada.
cystic fibrosis drug
The antimicrobial agent Mul-1867 for the treatment of bacterial lung infections in cystic fibrosis patients has been granted Orphan Drug Designation by the FDA.
atezolizumab lung cancer drug
The FDA has accepted Genentech’s Biologics License Application and granted Priority Review for the its product atezolizumab for the treatment of non-small cell lung cancer.
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According to a report by The Hill, the House Appropriations Committee voted Tuesday to exempt all electronic cigarettes and cigars currently on the market from rules proposed by the FDA.
scientists in lab lung cancer
The Oncologic Drugs Advisory Committee has voted in favor of the FDA waiting for results of an ongoing clinical trial before approving the EGFR inhibitor rociletinib for non-small cell lung cancer.
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The US FDA has issued new class-wide safety labeling changes for immediate-release (IR) opioid pain medications, which make up about 90% of all opioid prescriptions.
actelion drug approval
Actelion has announced the approval of Uptravi for the treatment of pulmonary arterial hypertension in Australia and New Zealand.
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The US FDA has approved a supplemental New Drug Application (sNDA) for Boehringer Ingelheim Pharmaceuticals' Stiolto Respimat for COPD.
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Hamilton Medical's C1 ventilator is now available with a new Neonatal option, providing optimal ventilation therapy for the tiniest and most fragile patients.
pneumacare
PneumaCare Ltd has received 510(k) clearance from the US FDA for its noninvasive, non-contact Thora-3DI imaging device.
asthma inhaler
AstraZeneca is voluntarily recalling close to 150,000 Tudorza Pressair inhalers because of flaws in the device's delivery system.
pfizer pneumonia vaccine
Doctors Without Borders (Médecins Sans Frontières) has filed a "patent opposition" in India to block Pfizer from patenting a pneumonia vaccine.
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The US FDA has approved reslizumab (Cinqair), a monoclonal antibody for adults with severe asthma who keep having attacks despite treatment with other medications.
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The US FDA has approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs.
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The FDA has proposed a ban on most powdered medical gloves in the US due to concerns they pose a substantial risk of illness or injury to healthcare providers and patients.
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GSK’s Advair Diskus achieved its primary endpoint in a LABA safety study of children aged 4-11 years with asthma.
lung cancer
The US FDA has approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration.