September 14, 2026

FDA approves muscle-targeted SMA therapy

The therapy inhibits myostatin signaling and is used with survival motor neuron 2-targeted treatment.

MDSpire News

September 08, 2026

FDA approves dual-energy AFib ablation catheter

The FDA based the authorization on results from Abbott’s FlexPulse study, which reported safety and effectiveness outcomes in paroxysmal atrial fibrillation.

MDSpire News

September 04, 2026

FDA approves first therapy for Alexander disease

The antisense oligonucleotide reduces production of the abnormal protein that accumulates in supportive cells in the brain.

MDSpire News

September 01, 2026

FDA expands essential thrombocythemia care

Phase 3 SURPASS ET data showed higher durable response rates with ropeginterferon alfa-2b-njft than with anagrelide.

MDSpire News

August 31, 2026

FDA approves hepcidin mimetic for PV

Phase 3 VERIFY results showed a 77% clinical response rate during weeks 20 to 32.

MDSpire News

August 31, 2026

Do antihistamines help atopic dermatitis?

First-generation H1 antihistamines likely increase cognitive impairment, with cognitive effects differing among second-generation antihistamines.

MDSpire News

August 28, 2026

FDA approves XFG-adapted COVID-19 vaccine

The 2026 to 2027 formulation aligns with FDA guidance on the preferred composition for COVID-19 vaccines beginning this fall.

MDSpire News

August 28, 2026

FDA approves bictegravir and lenacapavir for HIV

The treatment was evaluated in patients receiving complex antiretroviral regimens.

MDSpire News

August 28, 2026

FDA expands tirzepatide indication to cardiovascular risk reduction

SURPASS-CVOT compared tirzepatide head-to-head with dulaglutide in 13,299 participants.

MDSpire News

August 28, 2026

FDA monthly preview: Key September decisions to watch

Several FDA decisions across multiple specialties are expected this month.

MDSpire News