Biotech Stocks Facing FDA Decision In June 2021

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As per the latest CDC data, 49% of the total U.S population, i.e., 160 million people, including children over the age of 12, have received at least one shot of COVID-19 vaccine and 39.2 % of the population, which equates to 130 million people, are fully vaccinated.

With the number of new COVID-19 cases steadily declining in the country, things are getting close to normal - with a rebound in domestic travel and reopening of offices and schools.

However, scientific conferences and meetings like FDA advisory committee reviews, still continue to be organized virtually.

So far this month, only 2 *novel drugs have secured regulatory approval in the U.S. - Johnson & Johnson's Rybrevant and Apellis Pharmaceuticals' Empaveli - compared to 6 during the same period last year.

*Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.

Rybrevant was approved on May 21 as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations - epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Empaveli was approved on May 14 to treat adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, life-threatening blood disease.

Now, let's take a look at the biotech stocks facing FDA decision in June 2021.

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