Regulatory Science

PharmAla grants Jupiter Neurosciences exclusive U.S. rights to ALA-002

PharmAla Biotech has out-licensed its lead MDMA-derived candidate to Jupiter Neurosciences for up to US$100 million, retaining all rights outside the United
PharmAla Biotech has out-licensed its lead MDMA-derived candidate to Jupiter Neurosciences for up to US$100 million, retaining all rights outside the United
The Biotech Times Editorial Team  · 
Biologics

MiMedx to acquire Sanara MedTech in $350m regenerative medicine deal

MiMedx will pay $35 per share for Sanara MedTech in a cash-and-stock deal that nearly doubles its surgical revenue and targets combined 2027
MiMedx will pay $35 per share for Sanara MedTech in a cash-and-stock deal that nearly doubles its surgical revenue and targets combined 2027
The Biotech Times Editorial Team  · 
Regulatory Science

PolyPid secures FDA Priority Review for D-PLEX100 NDA

The Israeli biotech's surgical site infection candidate has a PDUFA date of 28 November 2026, a quarter ahead of prior guidance.
The Israeli biotech's surgical site infection candidate has a PDUFA date of 28 November 2026, a quarter ahead of prior guidance.
The Biotech Times Editorial Team  · 
Regulatory Science

Idorsia QUVIVIQ sales jump 62% as daridorexant pipeline broadens

Idorsia reported CHF 91 million in QUVIVIQ sales for H1 2026 and reaffirmed full-year guidance of CHF 200 million as it prepares to expand
Idorsia reported CHF 91 million in QUVIVIQ sales for H1 2026 and reaffirmed full-year guidance of CHF 200 million as it prepares to expand
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor DMD cell therapy data in The Lancet before FDA ruling

Deramiocel slowed upper limb decline by 54% versus placebo in a Phase 3 trial, with an FDA decision due 22 August 2026.
Deramiocel slowed upper limb decline by 54% versus placebo in a Phase 3 trial, with an FDA decision due 22 August 2026.
The Biotech Times Editorial Team  · 
Biologics

Crystalys raises $130m Series B for gout drug dotinurad

The oversubscribed round will fund two Phase 3 trials and commercialisation preparation for dotinurad, a once-daily URAT1 inhibitor for gout.
The oversubscribed round will fund two Phase 3 trials and commercialisation preparation for dotinurad, a once-daily URAT1 inhibitor for gout.
The Biotech Times Editorial Team  · 
Biologics

Humacyte wins FDA IND clearance for CTEV coronary bypass study

Humacyte's bioengineered coronary vessel cleared for a first-in-human Phase 2a trial in CABG patients, with study start targeted this quarter.
Humacyte's bioengineered coronary vessel cleared for a first-in-human Phase 2a trial in CABG patients, with study start targeted this quarter.
The Biotech Times Editorial Team  · 
Diagnostics

Sonablate highlights 10-year HIFU focal therapy data from 3,477 patients

A European Urology study of UK registry data found 0.1% prostate cancer-specific mortality and 3% metastatic progression at 10 years for focal HIFU.
A European Urology study of UK registry data found 0.1% prostate cancer-specific mortality and 3% metastatic progression at 10 years for focal HIFU.
The Biotech Times Editorial Team  · 
Diagnostics
Regulatory Science
Biologics

OraSure wins FDA EUA for second-generation OraQuick Ebola 2.0 test

OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
The Biotech Times Editorial Team  · 
Diagnostics

Medicus Pharma clears FDA review for SkinJect Gorlin Syndrome trial

The NASDAQ-listed biotech received a "Study May Proceed" letter for its Phase 2b NDA-enabling study of SkinJect in patients with Gorlin Syndrome.
The NASDAQ-listed biotech received a "Study May Proceed" letter for its Phase 2b NDA-enabling study of SkinJect in patients with Gorlin Syndrome.
The Biotech Times Editorial Team  · 

Mission Therapeutics divests AKI asset MTX652 to Dimerix for up to $292m

The Cambridge biotech sheds its renal USP30 programme to fund its Phase 1 Parkinson's candidate MTX325, receiving milestones and tiered royalties.
The Cambridge biotech sheds its renal USP30 programme to fund its Phase 1 Parkinson's candidate MTX325, receiving milestones and tiered royalties.
The Biotech Times Editorial Team  · 
Biologics

Cellution Biologics acquires SimpliDerm ADM business for up to $11m

Cellution Biologics is buying Elutia's SimpliDerm acellular dermal matrix unit to enter the US reconstructive surgery market.
Cellution Biologics is buying Elutia's SimpliDerm acellular dermal matrix unit to enter the US reconstructive surgery market.
The Biotech Times Editorial Team  · 
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