By Nick Paul Taylor
The FDA has deflated Ardelyx's attempt to recover quickly from a complete response letter. With Ardelyx looking to sidestep a request for another trial, the FDA held its ground and denied the appeal—leaving the biotech looking to a Hail Mary pass to overturn the decision.
read more
By Andrea Park
It doesn’t take an artificial intelligence-powered symptom checker to diagnose Ada Health with what is clearly a serious case of fundraising fever.
read more
By Robert King
Provider groups' latest legal filing in a lawsuit over the Biden administration surprise billing rule charges agencies are making it more difficult for them to prevail in arbitration disputes.
read more
By Fraiser Kansteiner
Robert Califf, President Joe Biden’s pick for the top spot at the FDA, has snared the support of the Senate Finance Committee chairman, thanks to a vague pledge to reform the agency’s accelerated approval pathway if he’s confirmed.
read more
By Max Bayer
Curevo Vaccine is hoping $60 million in financing will help the small biotech literally go head-to-head against GlaxoSmithKline's market-dominating shingles vaccine Shingrix.
read more
By Kevin Dunleavy
AstraZeneca's COVID-19 vaccine sales reached $4 billion in 2021. But the company said not to expect a similar performance this year, projecting a revenue percentage drop in the low-to-mid 20s. In all, AZ reported $37.4 billion in revenue in 2021, a 38% increase from last year.
read more
By Rebecca Torrence
Digital health unicorn Cadence inked a partnership with Community Health Systems to provide its remote patient monitoring and virtual care platform across the health system's national footprint in 16 states.
read more
By Nick Paul Taylor
AstraZeneca has scrapped its beta-specific COVID-19 vaccine. The removal of AZD2816 from the pipeline follows the conclusion of a phase 2/3 clinical trial that persuaded AstraZeneca to stick with Vaxzevria, its first-generation vaccine, rather than push ahead with plans to seek authorization for its beta-specific sibling.
read more
By Conor Hale
Philips has upgraded its smartphone-controlled handheld ultrasound system, adding pulse wave doppler support to help clinicians examine real-time blood flow across a range of diagnostic applications.
read more
By Dave Muoio
Forsta's “comprehensive” tech platform will allow Press Ganey to offer its healthcare clients a greater range of experience intelligence tools, the company said in this week's acquisition announcement.
read more
By Andrea Park
Amid the “hidden pandemic" of antibiotic-resistant infections, Day Zero Diagnostics is doubling down on its mission of developing tools to identify and profile those bacterial diseases as early as possible.
read more
By Sharon Klahr Coey
For Hologic’s first DTC commercial spot, the medical tech company which is primarily focused on women’s health, decided to go big—big star, big game, big message—Mary J. Blige, during the Super Bowl, encouraging women to get their screenings.
read more
