Regulatory & Policy

Systematic, data-driven science coverage · Wednesday, July 29, 2026
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Caldera taps reverse merger to advance TL1A × IL-23 bispecific

Caldera taps reverse merger to advance TL1A × IL-23 bispecific
Business

Adjuvia raises USD 8m for preclinical-stage mitochondrial therapy

Adjuvia raises USD 8m for preclinical-stage mitochondrial therapy
Business

AbCellera adds Vertex as latest TCE platform partner in autoimmune disease

AbCellera adds Vertex as latest TCE platform partner in autoimmune disease
Business

Qnovia bets on antimicrobial peptides with exclusive UVA deal

Qnovia bets on antimicrobial peptides with exclusive UVA deal
Business

LB Pharma raises USD 150m to expand LB-102 zinto three neuropsychiatric indications

LB Pharma raises USD 150m to expand LB-102 zinto three neuropsychiatric indications
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AbelZeta wins FDA clearance for registrational Phase II study of lupus nephritis CAR-T
Regulatory & Policy

AbelZeta wins FDA clearance for registrational Phase II study of lupus nephritis CAR-T

Rockville, Maryland-based AbelZeta Pharma has received US FDA clearance to proceed with a multi-center registrational Phase II trial of C-CAR168, an...

1d agoFDA briefing casts doubt on Capricor's deramiocel ahead of DMD advisory committee
Regulatory & Policy

FDA briefing casts doubt on Capricor's deramiocel ahead of DMD advisory committee

San Diego-based Capricor Therapeutics (Nasdaq: CAPR) faces a critical regulatory test on Tuesday when the US FDA's Cellular, Tissue, and Gene Therapies...

2d agoCHMP recommends Gilead's Trodelvy plus Keytruda for PD-L1-positive mTNBC
Regulatory & Policy

CHMP recommends Gilead's Trodelvy plus Keytruda for PD-L1-positive mTNBC

Sacituzumab govitecan (Trodelvy) in combination with pembrolizumab (Keytruda) has received a CHMP positive opinion for first-line treatment of...

2d agoCHMP recommends EU approval of Roche's Susvimo for nAMD
Regulatory & Policy

CHMP recommends EU approval of Roche's Susvimo for nAMD

Roche (SWX: ROG) has secured a positive CHMP recommendation for Susvimo (ranibizumab injection) 100 mg/mL for neovascular age-related macular degeneration,...

2d agoCHMP backs leriglitazone for early-stage cerebral adrenoleukodystrophy in children
Regulatory & Policy

CHMP backs leriglitazone for early-stage cerebral adrenoleukodystrophy in children

Leriglitazone (NEZGLYAL) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, positioning it...

2d agoEMA rejects arimoclomol for Niemann-Pick disease type C over efficacy concerns
Regulatory & Policy

EMA rejects arimoclomol for Niemann-Pick disease type C over efficacy concerns

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on July 23, 2026, recommending refusal of...

5d agoIcotyde gains CHMP backing as first oral IL-23 receptor antagonist for plaque psoriasis
Regulatory & Policy

Icotyde gains CHMP backing as first oral IL-23 receptor antagonist for plaque psoriasis

The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Icotyde (icotrokinra) as a plaque psoriasis...

5d agoSanofi abandons amlitelimab in atopic dermatitis despite positive Phase III data
Regulatory & Policy

Sanofi abandons amlitelimab in atopic dermatitis despite positive Phase III data

Sanofi (Nasdaq: SNY) announced on July 24, 2026 that it will not submit amlitelimab (SAR445229, KY1005), its OX40-ligand monoclonal antibody, for regulatory...

5d ago
The AllSci BriefSystematic R&D and deal news. Daily.
Amgen submits data to FDA challenging Tavneos withdrawal proposal in rare vasculitis
Regulatory & Policy

Amgen submits data to FDA challenging Tavneos withdrawal proposal in rare vasculitis

Amgen (Nasdaq: AMGN) submitted data and analyses to the US FDA on July 23, 2026, in support of its request for a formal hearing on Tavneos (avacopan), the...

5d agoAstraZeneca pulls Imfinzi EU expansion after CHMP questions benefit-risk in bladder cancer
Regulatory & Policy

AstraZeneca pulls Imfinzi EU expansion after CHMP questions benefit-risk in bladder cancer

AstraZeneca's bid to expand durvalumab (Imfinzi) into high-risk non-muscle invasive bladder cancer has ended in the EU after the European Medicines Agency...

5d agoProveca seeks re-examination of EMA rejection for pediatric intranasal pain spray KemSu
Regulatory & Policy

Proveca seeks re-examination of EMA rejection for pediatric intranasal pain spray KemSu

Denmark-based Cessatech said its commercialization partner Proveca intends to request a re-examination of a negative opinion issued by the European...

5d agoFDA begins review of Revolution's RAS(ON) inhibitor for pancreatic cancer
Regulatory & Policy

FDA begins review of Revolution's RAS(ON) inhibitor for pancreatic cancer

The US Food and Drug Administration has accepted for review Revolution Medicines' New Drug Application for daraxonrasib (RMC-6236), an oral RAS(ON)...

6d agoBridgeBio's encaleret advances toward first-ever ADH1 approval with FDA NDA acceptance
Regulatory & Policy

BridgeBio's encaleret advances toward first-ever ADH1 approval with FDA NDA acceptance

BridgeBio Pharma, Inc. (Nasdaq: BBIO) said the US FDA has accepted for filing its New Drug Application for encaleret, an investigational oral calcilytic, in...

6d agoMonopar advances first novel Wilson disease therapy in decades toward FDA approval
Regulatory & Policy

Monopar advances first novel Wilson disease therapy in decades toward FDA approval

Monopar Therapeutics Inc. (Nasdaq: MNPR), the Wilmette, Illinois-based biopharmaceutical company, has initiated a rolling submission of a New Drug...

6d agoFDA accepts Camurus' resubmitted CAM2029 application for acromegaly review
Regulatory & Policy

FDA accepts Camurus' resubmitted CAM2029 application for acromegaly review

Camurus AB (Nasdaq Stockholm: CAMX) said the US FDA has accepted for review its resubmitted New Drug Application for CAM2029, a long-acting subcutaneous...

Jul 17