Diagnostics

Vivos Inc. ships first IsoPet batches from in-house US facility

Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.
Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.
The Biotech Times Editorial Team  · 
Biotech

Taranis Capital, Fintech Times & Co-Labs Global Partner on DeepTech

Taranis Capital, The Fintech Times and Co-Labs Global have partnered to accelerate FinTech, AI, RegTech and BioTech growth through capital, media and collaboration.

Strategic collaboration combines capital, media reach and collaborative services to cut through market noise and enable faster, safer and more resilient innovation for those who need it most.

Taranis Capital, Fintech Times & Co-Labs Global Partner on DeepTech  · 
Biotech

UK robotics hits $258M in 2026 YTD funding; Cambridge leads all-time

Tracxn data show UK consumer robotics attracted $258M year-to-date in 2026, with Cambridge accounting for nearly 60% of all-time funding at $1
Tracxn data show UK consumer robotics attracted $258M year-to-date in 2026, with Cambridge accounting for nearly 60% of all-time funding at $1
The Biotech Times Editorial Team  · 
Biologics

ADARx wins FDA Fast Track for onvuzosiran in hereditary angioedema

ADARx Pharmaceuticals has secured Fast Track designation for its siRNA candidate onvuzosiran, now in Phase 3 trials for HAE prophylaxis.
ADARx Pharmaceuticals has secured Fast Track designation for its siRNA candidate onvuzosiran, now in Phase 3 trials for HAE prophylaxis.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

FDA awards Orphan Drug status to Lakefront's gamgertamig in pemphigus

Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.
Lakefront Biotherapeutics gains a third FDA designation for gamgertamig, its BCMAxCD3 bispecific T cell engager, as pemphigus joins its autoimmune pipeline.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor's DMD cell therapy BLA gets three-month FDA extension

The FDA has pushed Deramiocel's PDUFA date to 22 November 2026 after Capricor submitted 24-month HOPE-3 open-label extension data.
The FDA has pushed Deramiocel's PDUFA date to 22 November 2026 after Capricor submitted 24-month HOPE-3 open-label extension data.
The Biotech Times Editorial Team  · 
Regulatory Science

Femasys wins FDA modular PMA pathway for FemBloc birth control device

The NASDAQ-listed women's health company said the modular submission route lets regulators review key components before final FINALE trial data are available.
The NASDAQ-listed women's health company said the modular submission route lets regulators review key components before final FINALE trial data are available.
The Biotech Times Editorial Team  · 
Diagnostics

Milestone Pharma starts Phase 3 trial of etripamil for AFib-RVR

Milestone Pharmaceuticals has enrolled the first patient in ReVeRA-301, a pivotal Phase 3 study of self-administered etripamil nasal spray for atrial fibrillation with
Milestone Pharmaceuticals has enrolled the first patient in ReVeRA-301, a pivotal Phase 3 study of self-administered etripamil nasal spray for atrial fibrillation with
The Biotech Times Editorial Team  · 
Biologics

Alvotech and Lotus Pharmaceutical sign biosimilar deal worth up to $150m

Alvotech has licensed two biosimilar candidates to Lotus Pharmaceutical across the US and eight Asian markets, with milestone payments potentially reaching $150 million.
Alvotech has licensed two biosimilar candidates to Lotus Pharmaceutical across the US and eight Asian markets, with milestone payments potentially reaching $150 million.
The Biotech Times Editorial Team  · 
Regulatory Science

Erasca wins FDA Fast Track for pan-RAS molecular glue in PDAC

Erasca's ERAS-0015 has received Fast Track Designation for metastatic pancreatic adenocarcinoma, backed by a 57% response rate in second-line KRAS-mutant patients.
Erasca's ERAS-0015 has received Fast Track Designation for metastatic pancreatic adenocarcinoma, backed by a 57% response rate in second-line KRAS-mutant patients.
The Biotech Times Editorial Team  · 
Biologics

Leads Biolabs' opamtistomig posts 65% ORR in Phase 2 NSCLC study

Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
Updated data from over seven months of follow-up, including PFS rates, will be presented at WCLC on 14 September 2026.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Humacyte to file supplemental BLA for ATEV in dialysis access

Humacyte plans a November 2026 supplemental BLA filing to add haemodialysis access as a second approved indication for its bioengineered vessel.
Humacyte plans a November 2026 supplemental BLA filing to add haemodialysis access as a second approved indication for its bioengineered vessel.
The Biotech Times Editorial Team  · 
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