We are almost one month into the New Year, and it has been a busy month at the FDA.
New steps to facilitate efficient generic drug review have been outlined by the U.S. regulatory agency to enhance competition, promote access and lower drug prices. Seeking to tackle the epidemic of opioid addiction, the FDA announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old.
New policy steps for strengthening public warning and notification of recalls have been drafted to ensure that consumers have timely actionable information for protecting themselves from any FDA-regulated, recalled product.
On a more regulatory front, here are a few of the things that were of interest this month.
AstraZeneca's (AZN) Lynparza became the first drug to treat certain patients with metastatic breast cancer who have a "BRCA" gene mutation when it was greenlighted by the FDA on January 12, 2018. Lynparza was first approved by the FDA in 2014 to treat certain patients with ovarian cancer.
Two oral testosterone drug candidates namely, Jatenzo, developed by privately-held Clarus Therapeutics Inc., and TLANDO, developed by Lipocine Inc. (LPCN), proposed to help restore normal testosterone levels in hypogonadal men, were voted down by an FDA panel on January 9 and 10, respectively.
Now, let's take a look at the biotech stocks that await a ruling from the FDA in February 2018.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.