Patrick R. O'Neil, Executive Vice President, Chief Legal Officer & General Counsel of Ionis Pharmaceuticals Inc. (NASDAQ:IONS), recently sold 6,165 shares of the company's common stock. The shares ...

A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...

Scholar Rock is asking the U.S. Food and Drug Administration to approve apitegromab for people with spinal muscular atrophy.

It was a busy week for the biotech sector, with regulatory and pipeline updates. Sage Therapeutics SAGE was in focus after it rejected Biogen's BIIB acquisition proposal. Recap of the Week’s Most ...

Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started ...

Donald Trump continues to make waves in biopharma; Sage rejects Biogen’s unsolicited takeover offer; the obesity space sees ...

Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...

Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...

BIIB's regulatory filings are supported by late-stage data, which show that treatment with a higher Spinraza dose improves motor function in infants with SMA.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA ... This is in contrast to the approved 12 mg regimen of SPINRAZA, the brand name under which nusinersen is currently ...