The agency’s clearance marks its first for a piece of over-the-counter hearing aid software—and hails the long-awaited entry of the consumer tech giant to the sector.

Eli Lilly has again upped the ante in scaling up its manufacturing footprint, this time revealing an investment totaling $1.8 billion to expand production capacity at two plants in Ireland.

The Fierce Medtech Fierce 15 winner has been developing a cartridge-based, benchtop-sized machine to rapidly profile the body’s immune response to an invader—to help emergency department clinicians determine whether a patient has a bacterial versus viral infection, and if they may be at risk for developing sepsis.

The FDA has faulted AbbVie’s promotion of the migraine drug Ubrelvy, calling the company out for an ad featuring Serena Williams that went out of bounds with claims about how quickly the product relieves symptoms.

Just four months after Sanofi bet $80 million upfront on Fulcrum Therapeutics’ losmapimod, the program has ended in a phase 3 failure.

Tremfya will enter the UC space as J&J’s older Stelara, which is approved to treat both forms of IBD, nears biosimilar competition and Inflation Reduction Act-mandated price concessions.

Cancer biotech Oncternal Therapeutics is folding all its clinical trials and laying off staff, turning its energy toward exploring strategic alternatives such as asset sales, a merger or acquisition.

An ambitious project that was hatched during the early days of the coronavirus pandemic has hit a key milestone as Sanofi has completed construction of Modulus, a 500 million euros ($554 million) vaccine and biological medicine plant that can be quickly reconfigured to respond to a pandemic.