Regulation

Regulatory Science

Belite Bio completes NDA submission for tinlarebant in Stargardt disease

Belite Bio has filed its full NDA for tinlarebant, a once-daily oral therapy that would be the first approved treatment for STGD1.
Belite Bio has filed its full NDA for tinlarebant, a once-daily oral therapy that would be the first approved treatment for STGD1.
The Biotech Times Editorial Team  · 
Genomics

Cogent Biosciences presents APEX pivotal data for bezuclastinib in AdvSM

Bezuclastinib hit a 65% objective response rate in advanced systemic mastocytosis; Cogent plans to file its NDA in June 2026.
Bezuclastinib hit a 65% objective response rate in advanced systemic mastocytosis; Cogent plans to file its NDA in June 2026.
The Biotech Times Editorial Team  · 
Genomics

Disc Medicine reports durable anemia responses in RALLY-MF Phase 2

DISC-0974 hit major response rates of 50–64% across transfusion subgroups in myelofibrosis, with End of Phase 2 FDA talks targeted for late 2026.
DISC-0974 hit major response rates of 50–64% across transfusion subgroups in myelofibrosis, with End of Phase 2 FDA talks targeted for late 2026.
The Biotech Times Editorial Team  · 
Genomics

Kyntra Bio roxadustat shows TI benefit in LR-MDS regardless of RS status

Post-hoc MATTERHORN data presented at EHA 2026 show roxadustat achieved transfusion independence in both RS-positive and RS-negative lower-risk MDS patients.
Post-hoc MATTERHORN data presented at EHA 2026 show roxadustat achieved transfusion independence in both RS-positive and RS-negative lower-risk MDS patients.
The Biotech Times Editorial Team  · 

Lyell Immunopharma reports ronde-cel safety data at EHA 2026

Updated Phase 1/2 data in 108 LBCL patients show no Grade 3+ CRS and a 97% manufacturing success rate, supporting outpatient use.
Updated Phase 1/2 data in 108 LBCL patients show no Grade 3+ CRS and a 97% manufacturing success rate, supporting outpatient use.
The Biotech Times Editorial Team  · 
Regulatory Science

Novartis Rhapsido meets Phase 3 endpoints across three CIndU subtypes

RemIND trial data presented at EAACI 2026 show remibrutinib doubled complete response rates versus placebo in symptomatic dermographism, cold urticaria and cholinergic
RemIND trial data presented at EAACI 2026 show remibrutinib doubled complete response rates versus placebo in symptomatic dermographism, cold urticaria and cholinergic
The Biotech Times Editorial Team  · 
Regulatory Science

Sanofi wins FDA approval for Tzield in stage 3 type 1 diabetes

The accelerated approval covers children aged eight to 17 recently diagnosed with stage 3 T1D, making Tzield the first disease-modifying therapy in this setting.
The accelerated approval covers children aged eight to 17 recently diagnosed with stage 3 T1D, making Tzield the first disease-modifying therapy in this setting.
The Biotech Times Editorial Team  · 
Regulatory Science

Rafael Holdings completes Phase 3 NPC trial, targets NDA in H2 2026

Rafael Holdings hit last-patient-last-visit in its pivotal TransportNPC trial and expects to file an NDA for Trappsol Cyclo in the second half
Rafael Holdings hit last-patient-last-visit in its pivotal TransportNPC trial and expects to file an NDA for Trappsol Cyclo in the second half
The Biotech Times Editorial Team  · 
Diagnostics

Roche gains FDA nod for first PTEN companion diagnostic

The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.
The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.
The Biotech Times Editorial Team  · 
Diagnostics

Syndax revumenib shows broad activity across leukaemia studies at EHA

Five datasets presented at EHA 2026 show revumenib achieving high remission and MRD-negativity rates across multiple acute leukaemia subtypes and treatment settings.
Five datasets presented at EHA 2026 show revumenib achieving high remission and MRD-negativity rates across multiple acute leukaemia subtypes and treatment settings.
The Biotech Times Editorial Team  · 
Diagnostics

Roche's Tecentriq wins FDA Priority Review in stage III colon cancer

The FDA accepted Roche's sBLA for Tecentriq plus chemotherapy in dMMR/MSI-H stage III colon cancer, with a decision expected by 9 October
The FDA accepted Roche's sBLA for Tecentriq plus chemotherapy in dMMR/MSI-H stage III colon cancer, with a decision expected by 9 October
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

HUTCHMED sovleplenib hits Phase III primary endpoint in wAIHA

ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
ESLIM-02 Phase III data showed a 66% durable response rate versus 15% for placebo, supporting a priority-review NDA filed with China's NMPA.
The Biotech Times Editorial Team  · 
Genomics

Novartis del-brax Phase I/II FSHD study meets primary biomarker endpoint

Novartis says its AOC therapy del-brax hit biomarker endpoints in the FORTITUDE study, with Phase III now enrolling 200 FSHD patients.
Novartis says its AOC therapy del-brax hit biomarker endpoints in the FORTITUDE study, with Phase III now enrolling 200 FSHD patients.
The Biotech Times Editorial Team  · 
Pharmaceuticals

Novo Nordisk wins MHRA approval for oral Wegovy semaglutide pill

The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The UK becomes the first European country to approve a once-daily GLP-1 weight-loss tablet, based on Phase 3 data showing ~14% weight
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

OraSure wins FDA clearance for at-home STI urine collection kit

OraSure's Colli-Pee Dx kit, cleared for use with Roche cobas systems, enables self-collected urine testing for four STIs from home.
OraSure's Colli-Pee Dx kit, cleared for use with Roche cobas systems, enables self-collected urine testing for four STIs from home.
The Biotech Times Editorial Team  · 
Digital Health

Nyxoah raises $110m to accelerate Genio sleep apnoea launch in US

The Belgian medtech closed a $95m equity round and expects a $15m EIB loan tranche as it scales its FDA-approved Genio neurostimulator commercially.
The Belgian medtech closed a $95m equity round and expects a $15m EIB loan tranche as it scales its FDA-approved Genio neurostimulator commercially.
The Biotech Times Editorial Team  · 
Genomics

CONNECTA Therapeutics starts Phase IIa trial of CTH120 in fragile X

The Barcelona biotech has dosed its first participants in a 30-patient study of TrkB modulator CTH120, the only compound in late-stage development for
The Barcelona biotech has dosed its first participants in a 30-patient study of TrkB modulator CTH120, the only compound in late-stage development for
The Biotech Times Editorial Team  · 
Regulatory Science
Biotech

Humacyte ATEV beats AV fistula on catheter-free days in Phase 3

Humacyte's bioengineered vessel delivered 91 more catheter-free days than standard-of-care AV fistula in female dialysis patients, triggering a supplemental BLA filing.
Humacyte's bioengineered vessel delivered 91 more catheter-free days than standard-of-care AV fistula in female dialysis patients, triggering a supplemental BLA filing.
The Biotech Times Editorial Team  · 
Regulatory Science

Optimi Health ships psilocybin to UK for Phase 2 clinical trial

The Canadian GMP manufacturer completed its first UK psilocybin export, supplying 5mg capsules and biomass under Health Canada and UK Home Office authorisations.
The Canadian GMP manufacturer completed its first UK psilocybin export, supplying 5mg capsules and biomass under Health Canada and UK Home Office authorisations.
The Biotech Times Editorial Team  · 
Bioprocessing
Diagnostics

RadioMedix wins FDA approval for generic Ga-68 PSMA-11 PET agent

RadioMedix's generic gallium-68 PSMA-11 PET diagnostic for prostate cancer has received FDA approval, with the Houston facility clearing inspection with no observations.
RadioMedix's generic gallium-68 PSMA-11 PET diagnostic for prostate cancer has received FDA approval, with the Houston facility clearing inspection with no observations.
The Biotech Times Editorial Team  · 
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