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Before garnering approval on Tuesday, Onapgo had been rejected twice by the FDA.

Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular interventional devices, today announced its acceptance into the Total Product Life Cycle Advisory Program Pilot (TAP Pilot) by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA).

The funding agreement comes as Biogen revealed a modest Q4 sales beat, which analysts expect will be “overshadowed” by the company’s forecasted dip in 2025 revenues.

BioArctic received $100 million upfront with another $1.25 billion in potential milestone payments on the line for two pyroglutamate-amyloid-beta antibodies.

A pair of biotechs burst onto the scene Tuesday, exiting stealth with $100 million in financing each and tapping executives who made their names at bluebird bio and Karuna Therapeutics.

Nika Pharmaceuticals, Inc. announces that it is the beneficial owner of a production building and land valued at $2,045,209, located in Sofia Province, Bulgaria.