Medical and Pharmaceutical

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.

Agency feedback follows a Phase 3 miss in congenital hyperinsulinism; Rezolute will weigh its filing strategy after tumor HI data.

Seraxis notes are expected to convert into BetaNova stock if the merger closes; the first SR-02 patient dose is targeted for Q1 2027.

The designation offers prioritized FDA interaction, while a pivotal study and separate clearance submission still lie ahead.

Stoke plans to combine four Vineland-3 subdomains for its U.S. NDA after a Phase 3 readout expected in the third quarter of 2027.

The vaccine met the stricter direct test for 17 of 19 serotypes shared with Capvaxive, with two meeting an older threshold.

The Reykjavik approval doubles drug substance capacity available for U.S. supply; separate biosimilar applications remain under FDA review.

The 125-patient single-arm study had no control group, while Medtronic says U.S. payer coverage reaches 96% of commercial and Medicare insured lives.

The FDA label covers previously untreated adults with no known 17p deletion after a 282-patient trial against chemoimmunotherapy.

Among 109 treated patients, the median response lasted 12.1 months; the single-arm cohort offers no direct efficacy comparison.

The company says the agency has set no new action date, while its U.S. launch target remains conditional on approval.

Rebisufligene etisparvovec won U.S. approval on Sept. 17; Ultragenyx gave no date for a European decision.