Medical and Pharmaceutical

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.

SITC presentations will follow a three-year EVX-01 clinical update on Oct. 24; the 75% response rate was first reported in 2025.

Surrozen expects to dose DUET's first patient in Q4; clearance also meets a condition for a US$95.1M financing close around Oct. 20.

The first-line application is expected to be completed by year end; a separate monotherapy NDA has a Feb. 27, 2027 FDA target.

AstraZeneca or Daiichi Sankyo will sponsor the planned breast cancer study, with all three companies sharing trial costs and retaining drug rights.

The AUTUS pulmonary valve can later be widened by catheter; the FDA cited a 62-child study and flagged longer-term risks.

Japan approved use with gemcitabine and nab-paclitaxel; Novocure's Oct. 1 release gave no Japanese shipment or coverage date.

A small post hoc MRI subgroup improved after 72 weeks, while placebo comparisons came from other liver measures in the larger STEP UP dataset.

A one-year biomarker analysis could support accelerated approval while the same study runs toward possible full approval.

The monthly 200 mg dose beat placebo at Week 16; patients have already been dosed in two atopic dermatitis Phase 3 studies.

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.

The company expects to begin first human testing of its HC74-based ADC in advanced solid tumours in the fourth quarter of 2026.

The China extension followed 240 patients, with long-term safety as its primary aim, while Sagimet prepares a U.S. Phase 3 trial.

Atlas showed 13.9 per cent complete clearance on the rival pill at week 16 as Takeda awaits an FDA action in early 2027.

A 350-patient Phase 3 study is testing PSMA PET with MRI before biopsy; Telix's Sept. 30 release gives no readout or NDA submission date.

A 37.1-minute placebo-adjusted shift in sleep onset supports Vanda's plan to seek a third U.S. HETLIOZ indication.

DBV requested priority review for VIASKIN Peanut after reporting a 31.8-point responder advantage over placebo in VITESSE.

The package includes 12 months of stability data from a new manufacturer after two manufacturing-related FDA letters.

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.

HUTCHMED says the application covers MET-driven lung cancer after EGFR inhibitor treatment, supported by a 338-patient Phase 3 trial.

First U.S. approval covers peripheral thyrotoxicosis in MCT8 deficiency; Egetis expects commercial availability eight to 10 weeks after Sept. 28.

A signed trial pact covers ivonescimab and sonesitatug vedotin in gastrointestinal cancers; Summit expects the share sale to close by Oct. 2.

The closed SPR2015 deal carries a US$400M upfront payment; further value depends on development and commercial milestones.

The Sept. 25 adult Parkinson's approval clears one condition for a payment-rights purchase expected to close Sept. 29.

The 40-patient tipelukast study missed its week-24 liver-fat and triglyceride comparisons, although secondary HDL measures improved.

A September QIAGEN safety document lists 13 bacterial targets and 18 resistance markers for the newly cleared assay.