Regulatory Science

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  · 
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  · 
Regulatory Science

Ascendis Pharma reports five-year Phase 2 data for TransCon PTH

Palopegteriparatide sustained multi-organ benefits over five years in hypoparathyroidism, with 82% of patients meeting the multi-component response endpoint.
Palopegteriparatide sustained multi-organ benefits over five years in hypoparathyroidism, with 82% of patients meeting the multi-component response endpoint.
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  · 
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  · 
Regulatory Science

Rafael Holdings completes Phase 3 enrolment for NPC drug Trappsol Cyclo

Rafael Holdings has reached last-patient-last-visit in its 94-patient TransportNPC trial, with topline data and an NDA submission both expected in H2
Rafael Holdings has reached last-patient-last-visit in its 94-patient TransportNPC trial, with topline data and an NDA submission both expected in H2
The Biotech Times Editorial Team  · 
Regulatory Science

Teva closes $700m Emalex buy to add ecopipam for Tourette syndrome

Teva paid $700 million upfront for Emalex Biosciences, acquiring a Phase 3-complete D1 antagonist with an NDA filing expected in the second half of
Teva paid $700 million upfront for Emalex Biosciences, acquiring a Phase 3-complete D1 antagonist with an NDA filing expected in the second half of
The Biotech Times Editorial Team  · 
Regulatory Science

Tris Pharma wins FDA Orphan Drug Designation for TRN-257 in IH

The New Jersey biotech's once-nightly, low-sodium oxybate candidate secured ODD based on its potential to eliminate the disruptive mid-night second dose.
The New Jersey biotech's once-nightly, low-sodium oxybate candidate secured ODD based on its potential to eliminate the disruptive mid-night second dose.
The Biotech Times Editorial Team  · 
Regulatory Science

Alterity Therapeutics wins FDA alignment on ATH434 Phase 3 MSA trial

Alterity's End-of-Phase 2 meeting secured FDA agreement on trial design, dosing, and endpoints for its pivotal ATH434 programme in multiple system atrophy.
Alterity's End-of-Phase 2 meeting secured FDA agreement on trial design, dosing, and endpoints for its pivotal ATH434 programme in multiple system atrophy.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Regulatory Science

Cellectis wins FDA RMAT designation for allogeneic CAR-T lasme-cel

The Paris-based biotech secured RMAT status for its CD22-targeting off-the-shelf CAR-T candidate in relapsed or refractory B-cell acute lymphoblastic
The Paris-based biotech secured RMAT status for its CD22-targeting off-the-shelf CAR-T candidate in relapsed or refractory B-cell acute lymphoblastic
The Biotech Times Editorial Team  · 
Regulatory Science

Disc Medicine aligns with FDA on bitopertin CRL response path

Disc Medicine said a Type A FDA meeting confirmed the Phase 3 APOLLO study could support a traditional approval for bitopertin in EPP, with data
Disc Medicine said a Type A FDA meeting confirmed the Phase 3 APOLLO study could support a traditional approval for bitopertin in EPP, with data
The Biotech Times Editorial Team  · 
Bioprocessing
Regulatory Science

Alvotech wins FDA review acceptance for AVT16 vedolizumab biosimilar

The Iceland-based biosimilar specialist said the FDA has accepted its BLA for AVT16, a proposed interchangeable biosimilar to Takeda's Entyvio, for ulcerative colitis
The Iceland-based biosimilar specialist said the FDA has accepted its BLA for AVT16, a proposed interchangeable biosimilar to Takeda's Entyvio, for ulcerative colitis
The Biotech Times Editorial Team  · 
Regulatory Science

Telitacicept wins NMPA approval for Sjögren's disease in China

RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI
RemeGen's telitacicept becomes the first approved therapy for Sjögren's disease in China, backed by Phase 3 data showing significant improvements on both ESSDAI
The Biotech Times Editorial Team  · 
Regulatory Science

Telitacicept wins NMPA conditional approval for IgA nephropathy

China's NMPA has conditionally approved telitacicept for IgAN, marking the fourth indication for the dual BAFF/APRIL inhibitor and its first kidney disease clearance.
China's NMPA has conditionally approved telitacicept for IgAN, marking the fourth indication for the dual BAFF/APRIL inhibitor and its first kidney disease clearance.
The Biotech Times Editorial Team  · 
Regulatory Science

Agios licenses SYK inhibitor cevidoplenib from Oscotec in $1bn ITP deal

Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
Agios will pay $25m upfront for global rights to cevidoplenib, a next-generation oral SYK inhibitor targeting immune thrombocytopenia, with Phase 3 planned for 2028.
The Biotech Times Editorial Team  · 
Bioprocessing
Regulatory Science

Alvotech resubmits FDA BLAs for golimumab and aflibercept biosimilars

Alvotech has resubmitted US licence applications for AVT05 and AVT06 following FDA manufacturing queries at its Reykjavik facility, with a six-month review expected.
Alvotech has resubmitted US licence applications for AVT05 and AVT06 following FDA manufacturing queries at its Reykjavik facility, with a six-month review expected.
The Biotech Times Editorial Team  · 
Regulatory Science

PharmAla Biotech licenses ALA-002 U.S. rights to Jupiter Neurosciences

PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
PharmAla will receive up to $100m in milestones and royalties for exclusive U.S. rights to its non-racemic MDMA candidate ALA-002.
The Biotech Times Editorial Team  · 
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