
electroCore seeks FDA clearance for Quell in chemotherapy neuropathy
The application draws on 168 participants, including a preliminary randomized trial using a significance threshold of 0.2.

The application draws on 168 participants, including a preliminary randomized trial using a significance threshold of 0.2.

The developer will stop internal Rejuva gene-therapy work and forecasts cash into Q2 2027, ahead of a potential 2028 launch.

The benefit expense ratio improved to 90.6 per cent, but non-operating gains helped lift earnings and the annual forecast.
The nonprescription apraclonidine drops are approved for people aged 12 and older, with a U.S. retail launch expected in the coming months.
Ryzumvi's expanded indication triggers a milestone payment, while U.S. commercial rights belong to Viatris.
China’s indication includes patients aged 16 and older, while Japan’s covers adults; U.S. availability is expected in November after DEA scheduling.
GenSci holds exclusive China rights, while Foresee's licence provides milestone payments and a share of product revenue.
The oral drug's label covers immunocompromised adults whose lesions failed standard antivirals, with U.S. availability expected before the end of 2026.
WELTRUZA is expected in three strengths in the coming weeks, with no post-injection observation required, Teva says.
Guardant360 CDx can identify ESR1 mutations before progression in eligible advanced breast cancer; Guardant's Oct. 8 release gave no European payer terms.
The 220-person ZUPREME-2 trial also showed improved HbA1c; Zealand says the first participants have begun treatment in its Phase 3a program.
Nine-month test deliveries more than doubled, while third-quarter CyPath revenue awaits formal results.
PharmaLogic supplied doses to hospitals in Indiana and Ohio; Telix's Oct. 6 launch release gave no Pixclara sales target.
The designation offers prioritized FDA interaction, while a pivotal study and separate clearance submission still lie ahead.
The FDA label covers previously untreated adults with no known 17p deletion after a 282-patient trial against chemoimmunotherapy.
United says it believes it is entitled to an order instructing FDA to withdraw Yutrepia's approval; the parties have one week to propose a judgment.
A 37.1-minute placebo-adjusted shift in sleep onset supports Vanda's plan to seek a third U.S. HETLIOZ indication.
ECG-MR is cleared to flag possible valve disease in at-risk patients 65 and older, while Tempus's Sept. 28 release gave no rollout date.
First U.S. approval covers peripheral thyrotoxicosis in MCT8 deficiency; Egetis expects commercial availability eight to 10 weeks after Sept. 28.
The Sept. 25 adult Parkinson's approval clears one condition for a payment-rights purchase expected to close Sept. 29.
A September QIAGEN safety document lists 13 bacterial targets and 18 resistance markers for the newly cleared assay.
FDA cleared the weekly basal insulin for adults with type 2 diabetes on Sept. 24; Lilly expects the U.S. pen in the coming months.
The application seeks dosing for smaller children with APDS, and the FDA set Jan. 30, 2027 as its target action date.
Mirum expects U.S. availability in October after a 63-patient study; its prespecified new-lesion incidence endpoint missed the conventional threshold.
In the 257-person pivotal cohort, 42 per cent on 4 mg reached the scalp hair endpoint at Week 36, against 5 per cent on placebo.
The TIBA test joins two existing checks on new commercial lots as Mesoblast scales U.S. sales of its pediatric cell therapy.
Researchers trained the underlying models using billions of minutes of sensor data from users who joined its research programs
It is nearly as accurate as a mass spectrometer
If you can avoid spraying yourself with a toxic chemical, you probably should
The system also integrates endobronchial ultrasound to examine nearby lymph nodes
She held a book signing for 'One Scan Saved My Life' this week
It aims to identify an optimal dosing regimen for patients that minimizes anxiety
ŌURA has a long-standing focus on female well-being
The development represents a step forward in the company’s neuromuscular computing roadmap
The ability to confirm and treat cancer in the same day lets patients get an answer immediately
Radar technology has long played a vital role in aviation and automotive industries
The platform makes it possible to track disease progression and therapy effectiveness in real-time