fda-and-biotech News
Q32 Bio Stock Jumps on Strategic Asset Sale to Akebia Therapeutics
Deal for kidney drug candidate provides $12 million in near-term non-dilutive funding, extending the company's cash runway into the second half of 2027.
Vaccine Stocks Brace for Impact as FDA Signals Stricter Approval Rules
Citing child safety concerns, the agency's policy shift introduces significant regulatory headwinds for Pfizer, Moderna, and the broader biotech sector.
Vanda Shares Climb as FDA Begins Label Talks for Key Drug
Positive regulatory step for motion sickness treatment tradipitant comes after the drugmaker successfully fended off a hostile takeover bid earlier this year.
AbbVie Gains as SKYRIZI Wins Key Canadian Reimbursement Nod
The recommendation from Canada's drug agency expands market access for the blockbuster immunology drug, a critical pillar in AbbVie's post-Humira growth strategy.
Heartbeam Stock Surges 43% on Renewed FDA Strategy
The med-tech firm laid out a decisive two-pronged plan to address the FDA's rejection of its key cardiac software, sparking investor optimism.
Pacira BioSciences Surges on Lawsuit to Defend Key Pain Drug
Legal action triggers a 30-month stay on FDA approval for a generic version of its non-opioid pain medication, EXPAREL, shielding a key revenue stream.
AstraZeneca Gains FDA Approval for Imfinzi in Stomach Cancer
The regulator approved the blockbuster drug as the first immunotherapy for early-stage gastric cancer patients before and after surgery, opening a significant new market.
BeOne Medicines Gains on FDA Fast-Track for Lymphoma Drug
Shares rise after the FDA grants Priority Review for sonrotoclax, signaling an accelerated path to market for the company's next-generation BCL2 inhibitor.