Browsing Tag
United States Food and Drug Administration
193 posts
CroíValve appoints structural heart executive Jaime Wheeler as Lucy O’Keeffe becomes COO
CroíValve has appointed former Edwards Lifesciences executive Jaime Wheeler as chief executive officer, signalling a shift from technology validation towards larger clinical studies, regulatory execution and eventual commercialization of the DUO Adapt tricuspid valve system.
Can Secretome Therapeutics turn its expanded leadership team into a Duchenne breakthrough?
Secretome Therapeutics has recruited experienced clinical, operational, medical affairs and finance executives as the private biotechnology company prepares to move STM-01 deeper into development for Duchenne muscular dystrophy-associated cardiomyopathy. The appointments indicate that Secretome is building the organisation required for late-stage trials and potential commercialisation, although the ultimate value of that infrastructure will depend on whether STM-01 produces convincing clinical evidence.
Can Elisabeth Svanberg help Medincell turn clinical progress into durable value?
Medincell wants pharmaceutical executive Elisabeth Svanberg to join its board and lead its remuneration and nomination committee. The proposal comes as the French biotechnology company moves from platform development towards recurring royalty growth and potential multi-product commercialisation.
Can InstaMed Pharmaceuticals turn needle-free peptide strips into a credible global platform?
The Salt Lake City biotechnology company is moving its formulation specialist into the top job as it attempts to turn oral peptide films into a scalable international platform.
Stoke Therapeutics has enrolled its pivotal Dravet trial, but what must the August 3 call prove?
Stoke Therapeutics will discuss its second-quarter performance on August 3 after completing enrollment in the pivotal EMPEROR trial. Investors will be looking beyond quarterly revenue to assess spending, regulatory execution and preparations for a possible zorevunersen launch.
IHL-42X screening begins as Incannex Healthcare enters a faster-moving oral sleep apnea race
Incannex Healthcare begins IHL-42X screening as cash, buybacks and Apnimed’s FDA filing reshape the oral sleep apnea investment case.
Furoscix ReadyFlow approval triggers $45m bill as MannKind Corporation raises fresh capital
MannKind Corporation wins Furoscix ReadyFlow approval and raises $50 million as a $45 million acquisition payment reshapes the outlook.
IKT-001 gains orphan status, but Inhibikase Therapeutics still faces imatinib’s safety challenge
Inhibikase Therapeutics gains FDA orphan status for IKT-001 after a $50 million raise. See how trial costs and dilution shape the outlook.
Picard Medical can lift PMI’s quoted price 50-fold, but can it repair the balance sheet?
Picard Medical’s share consolidation could strengthen its quoted price and preserve market access, but investors still need evidence of improved equity, liquidity and commercial scale.
Dyne Therapeutics (NASDAQ: DYN) slides as $375m stock sale resets valuation
Dyne Therapeutics strengthens launch funding, but its discounted $375 million share sale tests whether regulatory progress can outrun dilution pressure.