Regulatory News

The FDA is adding a new indication to anthrax vaccine BioThrax, first approved in 1970, to prevent anthrax after suspected or confirmed exposure to Bacillus anthracis in individuals age 18 to 65.
Dabigatran (Pradaxa) has received FDA approval for prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery.
The FDA determined there is a low likelihood the products will lead to increased tobacco use in the population, prevent people from quitting, or cause those who have quit to relapse.
The FDA has cleared Mallinckrodt Pharma's INOmax DSIR Plus MRI device for delivery of INOmax (nitric oxide) for inhalation during MRI procedures.
Lobbyists for the e-cigarette industry have reached out to 2016 presidential candidates and have asked them to endorse vaping devices over traditional tobacco products, according to
Two COPD therapies from Novartis -- Utibron Neohaler and Seebri Neohaler -- have been approved by the FDA for the long-term maintenance treatment of airflow obstruction in patients with COPD.
INOmax (nitric oxide) for inhalation has received regulatory approval in Australia and Japan for pulmonary hypertension in conjunction with heart surgery.
The EU's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to expand the current therapeutic indication for Volibris in pulmonary arterial hypertension (PAH).
Auvi q
The FDA has announced that Sanofi US is voluntarily recalling its Auvi-Q epinephrine injection because patients may receive an inaccurate and inadequate dose.
The FDA says Novartis and Merck have jointly decided to voluntarily discontinue manufacture of Foradil Aerolizer "for business reasons."
Health groups are calling on the US FDA to investigate the therapeutic claims electronic cigarette manufacturers are allegedly making in reference to their products.
The FTC is seeking clearance from the Office of Management and Budget to collect information from e-cigarette marketers, which is the first step toward conducting the study.
The FDA has approved the use of ambrisentan (Letairis) in combination with tadalafil (Cialis) as up-front therapy for pulmonary arterial hypertension (PAH) to reduce the risk of worsening disease and improve exercise ability.
flu virus
Focus Diagnostics’ influenza and RSV molecular test has been cleared for an additional 46 influenza A and influenza B strains and seven additional RSV strains.
Keytruda (pembrolizumab, Merck & Co) was just FDA-approved to treat patients with advanced (metastatic) NSCLC with tumors that express a protein called PD-L1, according to an agency news release.
With the Improving Access to Clinical Trials Act (IACT) of 2009 set to expire on October 5, 2015, the Cystic Fibrosis Foundation championed a new bill to make the IACT legislation permanent.
In patients with late-onset asthma who have elevated blood eosinophils, the anti-interleukin 5 (IL-5) antibody reslizumab can reduce exacerbations by 75% compared with placebo.
Tobacco deadlier than ever
The company’s submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act), according to the FDA.
The US FDA has approved the LAMA tiotropium bromide (Spiriva Respimat, Boehringer Ingelheim) for long-term maintenance treatment of asthma in people aged 12 years and older.
seasonal flu vaccine
If approved, the vaccine would become the first adjuvanted seasonal influenza vaccine licensed for use in adults aged 65 and older in the US.