North America

The United States and Canada.

Cingulate publishes Phase 3 data for CTx-1301 ADHD candidate

All three dose levels of Cingulate's once-daily dexmethylphenidate tablet beat placebo on the ADHD-RS-5 scale, with the highest dose yielding an
All three dose levels of Cingulate's once-daily dexmethylphenidate tablet beat placebo on the ADHD-RS-5 scale, with the highest dose yielding an
The Biotech Times Editorial Team  · 
Biologics

Diakonos Oncology doses first patients in DOC1021 melanoma trial

The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
The Houston biotech has initiated its Phase 1/2 DOC-RM study in refractory melanoma, with early safety results expected by end of 2026.
The Biotech Times Editorial Team  · 
Biologics

Disc Medicine eyes two pivotal programmes by 2027 after busy Q2

The Watertown biotech reported $718m in cash runway to 2029 and flagged a Q4 Phase 3 readout for bitopertin in EPP as its nearest catalysts.
The Watertown biotech reported $718m in cash runway to 2029 and flagged a Q4 Phase 3 readout for bitopertin in EPP as its nearest catalysts.
The Biotech Times Editorial Team  · 
Regulatory Science

Eton Pharmaceuticals files PAS to extend KHINDIVI to under-fives

Eton has submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI's hydrocortisone label to children under five with adrenal insufficiency.
Eton has submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI's hydrocortisone label to children under five with adrenal insufficiency.
The Biotech Times Editorial Team  · 
Biologics

Keros Therapeutics earns $20m milestone as elritercept Phase 3 enrols

Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
Keros will receive a $20m payment from Takeda after the ELRiSE MDS Phase 3 trial dosed its first patient, with 25% to be distributed to
The Biotech Times Editorial Team  · 
Biologics

Madrigal Pharmaceuticals posts $364m Q2 Rezdiffra sales, up 71%

Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
Madrigal's MASH therapy Rezdiffra surpassed 50,000 active patients and nearly $1.3bn in trailing annual sales as the company advanced an oral GLP
The Biotech Times Editorial Team  · 
Biologics

Celcuity gedatolisib gains NCCN Category 1 status in breast cancer

REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS
REVTORPYK earned a preferred second-line NCCN listing just 16 days after FDA approval, backed by Phase 3 data showing a 7.3-month PFS
The Biotech Times Editorial Team  · 

TScan Therapeutics doses first patient in Phase 3 ALLOHA-2 trial

TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
TScan's TCR-T therapy TSC-101 has entered pivotal Phase 3 testing in AML and MDS patients following allogeneic stem cell transplant.
The Biotech Times Editorial Team  · 
Biologics

Allogene wins FDA RMAT and Fast Track tags for cema-cel in LBCL

Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
Allogene's allogeneic CAR T candidate cema-cel gained dual FDA designations backed by ALPHA3 interim data showing 58% MRD clearance in first-line large
The Biotech Times Editorial Team  · 
Biologics

Claris Bio raises $118m Series B to fund pivotal LSCD eye-drop study

The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The New Jersey biotech secured the round from eight investors to advance CSB-001, a recombinant protein eye drop, into two pivotal trials in 2027.
The Biotech Times Editorial Team  · 
Biologics

Dyne Therapeutics gains FDA Priority Review for DMD drug z-rostudirsen

Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
Dyne's BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy has a PDUFA date of 21 January 2027, as the company readies for
The Biotech Times Editorial Team  · 
Diagnostics

MannKind's nintedanib DPI clears Phase 1b safety bar in IPF

INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
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

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  · 
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  · 
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

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  · 
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