Regulatory Science

Regulatory Science

Abivax clears FDA pre-NDA meeting for obefazimod in ulcerative colitis

The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
The Paris-listed biotech said the FDA endorsed its NDA submission strategy for obefazimod, keeping a year-end 2026 filing on track.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Capricor adcom setback leaves deramiocel fate with FDA

An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
An FDA advisory panel voted 9-3 against effectiveness of deramiocel for DMD cardiomyopathy, but the PDUFA date of 22 August 2026 remains in place.
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
Regulatory Science

Pfizer-BioNTech win EC nod for XFG-adapted COVID-19 vaccine

The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
The European Commission has authorised the 2026-2027 COMIRNATY formula targeting the XFG variant of JN.1, covering all 27 EU member states plus Iceland
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  · 
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  · 
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  · 
Regulatory Science
Biologics

60 Degrees Pharma options FSU castanospermine IP for tick-borne diseases

The NASDAQ-listed vector-borne disease specialist has secured exclusive option rights to FSU's castanospermine IP covering four tick-borne indications.
The NASDAQ-listed vector-borne disease specialist has secured exclusive option rights to FSU's castanospermine IP covering four tick-borne indications.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

DBV Technologies targets Q3 BLA filing for VIASKIN Peanut Patch

DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
DBV Technologies expects to submit its peanut-patch BLA in Q3 2026, backed by $174.9m in cash and active FDA engagement.
The Biotech Times Editorial Team  · 
Regulatory Science

Adneuris licenses cebranopadol to Conba for Greater China pain market

Adneuris will receive $17.5m upfront and up to $100m in milestones as Conba gains rights to the dual-receptor pain candidate across Greater China.
Adneuris will receive $17.5m upfront and up to $100m in milestones as Conba gains rights to the dual-receptor pain candidate across Greater China.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Arbutus files international LNP patent suits against Pfizer and BioNTech

Arbutus and Genevant have launched three international lawsuits over LNP patents while banking $178m from a Moderna settlement.
Arbutus and Genevant have launched three international lawsuits over LNP patents while banking $178m from a Moderna settlement.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Novartis Fabhalta wins FDA traditional approval in IgA nephropathy

Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.
Iptacopan slowed eGFR decline by 48% versus placebo over two years in the Phase III APPLAUSE-IgAN study, converting an accelerated approval granted in 2024.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Bavarian Nordic files chikungunya vaccine for approval in Brazil

Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
Partner Eurofarma has submitted CHIKV VLP to Anvisa, targeting a country that reported more than half of global chikungunya cases in 2025.
The Biotech Times Editorial Team  · 
Biologics
Regulatory Science

Elevar Therapeutics receives FDA CRL for rivoceranib-camrelizumab in HCC

The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The FDA cited manufacturing deficiencies at a listed site, not clinical data concerns, in declining to approve the first-line hepatocellular carcinoma combination.
The Biotech Times Editorial Team  · 
Regulatory Science

Claria Medical wins FDA De Novo clearance for hysterectomy device

The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Claria System is the first integrated tissue containment and removal device cleared by the FDA, cutting median uterine extraction time to four minutes.
The Biotech Times Editorial Team  · 
Regulatory Science

Incannex secures US patent for IHL-42X sleep apnoea therapy to 2040

Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
Incannex Healthcare has won a USPTO patent covering its oral OSA combination therapy IHL-42X, with baseline protection running to July 2040.
The Biotech Times Editorial Team  · 
Regulatory Science

CervoMed secures US patent on neflamapimod for pure DLB to 2042

CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
CervoMed has received a USPTO notice of allowance for a patent covering neflamapimod in pure dementia with Lewy bodies, extending protection into 2042.
The Biotech Times Editorial Team  · 
Regulatory Science

Cingulate secures first US patent on CTx-1301 ADHD tablet

The Kansas City biopharmaceutical company said US Patent No. 12,653,791 protects its trimodal dexmethylphenidate formulation through December 2042.
The Kansas City biopharmaceutical company said US Patent No. 12,653,791 protects its trimodal dexmethylphenidate formulation through December 2042.
The Biotech Times Editorial Team  · 
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