Fierce Biotech2h
Chutes & Ladders—FDA rocked by leadership shake-ups
As the Department of Health and Human Services grapples with the fallout of mass layoffs directed by Secretary Robert F.
Bizcommunity on MSN15h
Sanofi-Novavax deal in jeopardy as FDA halts vaccine approval
Dr Sara Brenner, the FDA's principal deputy commissioner, has paused the approval process for Novavax's Covid-19 vaccine by ...
FDA delay on Novavax vaccine approval could be bellwether for vaccine sector: BofAS
The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...
Fierce Pharma19h
Amid FDA tumult, agency misses decision deadline on Novavax's COVID shot
Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...
1NVAX, SNY : Despite Headwinds, Biotech Sell-Off Could Offer Buying Opportunity: Analyst
Biotech stocks face a tough 2025 with SMid-cap losses up to 40% YTD. BofA cites FDA changes, tariffs, and capital struggles but notes potential opportunities.
Why Is French Pharma Giant Sanofi Stock Trading Higher On Thursday?
Sanofi's rilzabrutinib receives FDA orphan drug designation for two rare diseases. Clinical studies show meaningful response ...
The Harvard Crimson22h
FDA Layoffs, Funding Cuts Cast Shadow Over Biopharma Industry
Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...
Healio22h
Rilzabrutinib granted orphan drug designation for IgG4-related disease
The FDA has granted orphan drug designation to rilzabrutinib for IgG4-related disease and warm autoimmune hemolytic anemia, ...
Zacks Investment Research on MSN23h
SNY's Rilzabrutinib Gets FDA's Orphan Drug Tag for Two Rare Diseases
Sanofi SNY announced that the FDA has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, ...
FDA approves Qfitlia to cut bleeding episodes in patients with hemophilia
The U.S. Food and Drug Administration has approved Sanofi's Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce ...
Sanofi's Rilzabrutinib Gets FDA's Rare-Disease Drug Designation
Sanofi said that its Rilzabrutinib treatment was granted orphan drug designation, which is used in the U.S. by the Food and Drug Administration. The designation is a status assigned to a medicine ...
Sanofi Says Rilzabrutinib Granted Orphan Drug Designation in the U.S.
Dow Jones Newswires is a market-moving financial and business news source, used by wealth managers, institutional investors and fintech platforms around the world to identify trading and investing ...