Posts

The annual meeting of the American Headache Society (AHS) is being held in Denver, Colorado from June 9-12. Here’s a look at just some of the wide-ranging research being presented.

It’s game day for bluebird bio. The company, battered by layoffs and cash concerns, faces a two-day crucible as the U.S. Food and Drug Administration’s Cell, Tissue and Gene Therapies Advisory Committee will give two lentiviral vector gene therapies a thumbs up or down.

Vertex Pharmaceuticals announced on Wednesday that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to the company’s candidate, inaxaplin (VX-147). Inaxaplin was granted the designation for the treatment of APOL1-mediated focal segment glomerulosclerosis (FSGS).

Advisers to the U.S. Food and Drug Administration on Tuesday voted overwhelmingly to recommend that the regulatory agency authorize Novavax Inc.’s COVID-19 vaccine for use in adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics.

The U.S. Food and Drug Administration approved the use of Sanofi and Regeneron Pharmaceuticals Inc.’s anti-inflammation drug Dupixent to treat eczema in young children, the two companies said on Tuesday.

Bayer is building an oncology powerhouse. The Germany-based biopharma leader is on a mission to become one of the top 10 oncology companies by 2030, and an ambitious mission requires an equally driven leadership team. To that end, Bayer snagged ex-GSK global oncology head Christine Roth to lead the company’s Oncology Strategic Business Unit, then dipped into GSK waters again to bring Tara Frenkl on board as head of oncology development.

Bluebird bio’s blood disorder treatment demonstrates “clinically meaningful” benefit in patients, staff reviewers at the U.S. Food and Drug Administration said in briefing documents published on Tuesday.

Abbott Laboratories said on Saturday that the company has reopened its baby formula production plant in Sturgis, Michigan, taking a step toward alleviating an acute nationwide shortage that has sent parents scrambling for supplies.

U.S. Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc.’s vaccine, even as the company’s data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19.

A federal agency will start a review if the U.S. Food and Drug Administration properly conducted the health regulator’s inspection of Abbott’s Michigan plant and oversaw baby formula recalls that led to severe shortages in the United States.