North America

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

Curium's BEXLUTRY, a 505(b)(2) lutetium Lu 177 dotatate equivalent, has received FDA approval for somatostatin receptor-positive GEP-NETs in adults.

Telix Pharmaceuticals has secured FDA approval for Pixclara, the first radiopharmaceutical PET imaging drug cleared in the US for glioma diagnosis.

Final PAPILLON Phase 3 data show a 34.3-month median overall survival with amivantamab plus chemotherapy, the longest reported in this historically difficult-to

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

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

YY003 hit its composite primary endpoint in 80.8% of participants at the 40-unit dose, with rapid onset by week one and no neutralising

Tenaya Therapeutics has secured RMAT designation for TN-401, its AAV9-based gene therapy for PKP2-associated ARVC, backed by Phase 1b/2 interim data.

Veracyte is adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio, with commercialisation targeted for late 2028.

Axogen is selling 4.91 million shares at $42.50 each, with proceeds earmarked to finance its pending acquisition of BioCircuit Technologies.

Femasys has linked with specialist fertility lender CapexMD to offer patients financing for its FemaSeed intratubal insemination portfolio across OB/GYN practices.

WuXi AppTec's TIDES platform sets out the chemistry, purification and stability challenges that arise when engineering oligonucleotides for monthly or longer dosing

Nano-X Imaging grew Q2 revenues to $4.2m but recorded a $40.7m intangible asset impairment, widening its GAAP net loss to $55.5m.

Preclinical data show pelareorep maintained tumour-reducing activity when combined with a pan-RAS inhibitor, with no evidence of antagonism between the two agents.

The Littleton, Massachusetts firm said the order continues a programme running since 2018 and expects a long-term manufacturing agreement to follow.

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

Post-hoc Phase 3 data show YCANTH cleared molluscum in over half of long-duration patients, while VP-315 showed abscopal-like activity in untreated

The Québec cannabis producer has upsized its syndicated debt facility by C$30m and extended its maturity to December 2029.

The Houston CNS oncology company said the senior secured facility extends its cash runway into 2028 and funds commercial scale-up of its CSF assay