News

Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
FDA
FEATURED STORIES
The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back.
At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
THE LATEST
Virios Therapeutics announced Monday its lead asset IMC-1 fell short of its primary endpoint in the Phase IIb FORTRESS study in patients with fibromyalgia.
Research on Alzheimer’s, specifically in neuroscience, continues with the Alzheimer’s Drug Discovery Foundation, Critical Path Institute, Abbvie, AlzeCure Pharma and more.
FDA
The FDA approved bluebird bio’s lentiviral vector (LVV) eli-cel Friday as the first therapy to slow the progression of neurologic dysfunction in juvenile boys with early, active CALD.
Both Bristol Myers Squibb and AbbVie filed a WARN notice with the California state government stating they intend to lay off up to 360 people.
As a leading biotech hub, the second city still ranks far below many other U.S. locations. That is starting to change, however, as new companies move into the heart of the BioMidwest region.
FDA
With 33 approvals from the FDA, Merck’s checkpoint inhibitor Keytruda has become a powerhouse oncology drug and is likely to continue to rack up more regulatory wins.
The FDA has a broad range of activities in the drug and medical device space. Here’s a look at the agency’s work this week.
The FDA has two PDUFA dates on its calendar this week, with two extra days slotted for an advisory committee meeting to evaluate drug applications from three companies.
Intellia Therapeutics reported early, positive signs from its in vivo gene therapies for both transthyretin (ATTR) amyloidosis and hereditary angioedema Friday.
AstraZeneca’s rare disease subsidiary Alexion posted positive late-stage results from a potential complementary treatment for paroxysmal nocturnal hemoglobinuria.