The expanded rollout will use cloud-based HALO AP, which the Oct. 15 release identifies as research use only in the United States.
Gilead gets exclusive development rights to three discovery programmes, with preclinical and later milestone payments contingent on progress.
China’s indication includes patients aged 16 and older, while Japan’s covers adults; U.S. availability is expected in November after DEA scheduling.
The approval adds adults with high-grade, BCG-unresponsive disease ahead of the Jan. 6, 2027 review target.
Cash is payable at closing, subject to antitrust conditions; two announced voucher agreements total US$413 million.
The 13-person study had no control group and a safety primary endpoint, with a separate CVID readout expected in November.
The court awarded appeal costs; the A$7.40-a-share deal was terminated in December 2025, and Mayne is pursuing damages.
The Oct. 7 letter addresses quality-system responses, while Olympus says it brings no new production or distribution restrictions.
PAH sales continue, PH-ILD promotion ends and cash payments run into April 2027; Liquidia expects to fund them without new financing.
The adjusted earnings midpoint rises six cents to US$11.10 a share as drug sales grow faster than medical technology revenue.
The 145-patient MAXPIRe study missed its lung-function endpoint; safety was comparable to placebo and graft-versus-host disease trials continue.
The treatment improved itch scores by 0.98 points more than placebo, with a supplemental U.S. drug application planned for the first half of 2027.
GenSci holds exclusive China rights, while Foresee's licence provides milestone payments and a share of product revenue.
The uncontrolled SYNCHRONICITY study reported a 3.6-letter vision gain at six months, with improvements maintained through two years.
The 60 mg dose met ALOFT-IPF's lung-function endpoint, but the topline release gives no effect size or filing date.
ICP-B161 is the company's fifth candidate to enter clinical development in 2026; the release gives no enrollment timetable.
The FDA has accepted the ADH1 application for priority review, with a May 8, 2027 target decision date.
The FDA accepted the uveitic macular edema application after MEERKAT met its primary endpoint and SANDCAT did not.
The oral drug's label covers immunocompromised adults whose lesions failed standard antivirals, with U.S. availability expected before the end of 2026.
EXCALIBER-RRMM met its second primary endpoint, with median progression-free survival estimated at 42 months versus 20 months.
The Oct. 8 label covers IV treatment from age two and Hybreza injections from age 12 for patients weighing at least 40 kilograms.
The FDA reviewed data from 12 cancer types, but Natera disclosed no performance figures or date for a marketing submission.
ICONIC-LEAD's two-year skin clearance results set a longer follow-up point for Alumis's investigational oral psoriasis drug.
WELTRUZA is expected in three strengths in the coming weeks, with no post-injection observation required, Teva says.
The continuous-treatment cohort showed symptom gains as Alumis targets a fourth-quarter U.S. drug application.
Guardant360 CDx can identify ESR1 mutations before progression in eligible advanced breast cancer; Guardant's Oct. 8 release gave no European payer terms.
A European Radiology paper tested DeepHealth's MRI risk score on 787 men; simulated biopsy savings have yet to be shown in practice.
The designations cover a colorectal cancer combination and lung cancer monotherapy, both based mainly on a first-in-human study.
The 220-person ZUPREME-2 trial also showed improved HbA1c; Zealand says the first participants have begun treatment in its Phase 3a program.
The biopsy measure improved against placebo after a gluten challenge, with p=0.0176; argenx plans Phase 3 development.
The voucher came with Genglycos approval; payment awaits an antitrust waiting period and other closing conditions.
The 510(k) decision covers resting ECG use in adults and children, but HeartSciences has set no device launch date.
Nine-month test deliveries more than doubled, while third-quarter CyPath revenue awaits formal results.
Vaxcyte expects both underwritten offerings to close Oct. 9, adding funds for adult vaccine trials and manufacturing ahead of a planned U.S. filing.
PharmaLogic supplied doses to hospitals in Indiana and Ohio; Telix's Oct. 6 launch release gave no Pixclara sales target.
The Oct. 5 placement issued 4.84 million shares at US$1.16 each and gave the placement agent warrants for another 387,464 shares.
The primary IPI 3 to 5 cohort showed a 0.49 hazard ratio, while the partners plan regulatory talks without a stated filing date.
The study will test tablets after 21 weeks of injections in about 195 adults, with weight change tracked through week 33.
Quantum said on Oct. 6 it had entered a Study Start-Up Agreement; it gave no first-dose or readout date.
Orexo expects to announce final issue terms preliminarily on Nov. 3 and plans a shareholder vote for Nov. 6.









































