Regulatory Science

Aquestive Therapeutics has refiled its FDA application for a needle-free sublingual epinephrine film after cutting pouch-opening time from 17 seconds to three.

RWS has put its Tridion Agent and Tridion Connect tools into public preview, targeting regulated industries managing high-volume technical documentation.

The FDA has accepted PolarityBio's SkinTE biologics application with Priority Review, setting a PDUFA action date of 16 March 2027.

Two-year ORIGIN 3 data showed atacicept-vymj stabilised kidney function and slashed composite disease progression risk, supporting a full FDA approval filing in Q4

Elevar has submitted a marketing authorisation application to the EMA for its selective FGFR2 inhibitor, backed by a 46.5% response rate in second-line

Pharmazz's endothelin-B receptor agonist sovateltide gains Orphan Drug Designation for neonatal hypoxic-ischaemic encephalopathy, unlocking US development incentives.

The La Jolla biotech secured FDA alignment on Phase 3 design for its injectable submental fat treatment, clearing the path to a 505(b)(2

The three organisations have released a four-course online series to help healthcare workforces comply with US federal information blocking rules now under active

CAMP4 Therapeutics has secured MHRA authorisation to include UK sites in its global Phase 1/2 study of CMP-002, an ASO targeting SYNGAP1-related

The US ad watchdog ruled that Nucleus IVF+ marketing overstated accuracy for disease risk, height, IQ and eye colour; Nucleus will appeal.

MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.

China's NMPA has accepted the NCX 470 glaucoma NDA filed by Nicox's licensee Ocumension, with a regulatory decision expected within 12 to 18

All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.

The Munich biotech will use the HERA Invest-backed funds to progress its interferon-lambda mRNA candidate into Phase 2b trials in asthma and COPD.

The San Diego biotech plans a first-in-human study of its BioJet capsule delivering adalimumab orally, with data expected in early 2027.

Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.

The FDA has authorised doubling Symvess's expiry dating, easing hospital inventory management for the bioengineered vascular conduit approved in 2024.

The FDA has accepted Roche's sBLA for satralizumab in MOGAD, a CNS autoimmune disease with no approved treatments, with a decision due January 2027.

Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.

The Cambridge, Massachusetts biotech secured FDA acceptance of its Oxnimbi NDA with a PDUFA date of 28 February 2027, as it raised $221m in a