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Biotech Stocks Facing FDA Decision In April 2021

fdadecision april28 27mar21 lt

As we enter the second quarter of the year, it's time to take a look back at some of the news stories that made headlines on the regulatory front in March.

BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections, was granted FDA clearance on March 17. This is the first SARS-CoV-2 diagnostic test to be authorized for marketing under traditional premarket review process, paving way to be marketed beyond the public health emergency. All the other SARS-CoV-2 diagnostic tests have been authorized by the FDA under an Emergency Use Authorization.

Memic Innovative Surgery Ltd's Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients, was authorized for marketing by the FDA on March 1. It is the first and only FDA-authorized surgical robotic platform that is designed to replicate the motions and capabilities of a surgeon's arms, with shoulder, elbow and wrist joint.

Four novel drugs were approved by the FDA in March taking the tally of new drug approvals in the first quarter of this year to 14. This compares with 11 new drug approvals in the first quarter of 2020. In all, a total of 53 novel drugs were approved last year.

Let's take a look at what's in store for April 2021.

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