fda-and-biotech News
Elanco Shares Climb on Historic FDA Animal Drug Authorization
Company receives the first-ever Emergency Use Authorization for an animal drug to combat the growing threat of New World screwworm to U.S. livestock and pets.
Syndax Shares Fall 8% in Classic 'Sell the News' FDA Approval
Investors take profits on the biotech's landmark leukemia drug approval, overshadowing the major regulatory win as focus shifts to commercial launch.
Syndax Pharma Surges on FDA Approval for First-in-Class Leukemia Drug
The U.S. regulator greenlights Revuforj for a common, hard-to-treat form of Acute Myeloid Leukemia, marking a pivotal commercial milestone for the company.
Biogen Bets Big on Immunology with $1 Billion Licensing Deal
Company secures rights to a novel oral anti-inflammatory drug, signaling a strategic push beyond its core neuroscience franchise.
Kura Oncology Gains on $30M Milestone for Leukemia Drug Trial
Payment from partner Kyowa Kirin follows the start of a pivotal Phase 3 study for ziftomenib, with a key FDA decision for the drug expected next month.
Foghorn Therapeutics Secures $110 Million to Advance Cancer Drug Pipeline
Financing extends the company's cash runway into 2027, funding key clinical trials for its novel gene-regulating therapies.
GSK Shares Fall Despite FDA Approval for Comeback Cancer Drug Blenrep
Investors weigh commercial concerns from a restrictive label against clinically compelling trial data for the multiple myeloma treatment, which was previously withdrawn from the market.
Kura Oncology Secures $30M Payment Advancing Key Leukemia Drug
Milestone from partner Kyowa Kirin triggered by start of pivotal Phase 3 trial for ziftomenib in frontline acute myeloid leukemia, bolstering the company's finances.