Regulatory & Policy

Systematic, data-driven science coverage · Saturday, August 8, 2026
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Pfizer Q2'26: Mevrometostat, tilrekimig and sigvotatug vedotin shape pipeline outlook

Pfizer Q2'26: Mevrometostat, tilrekimig and sigvotatug vedotin shape pipeline outlook
Business

Gilead Q2'26: BIC/LEN nears approval as weekly HIV pipeline expands

Gilead Q2'26: BIC/LEN nears approval as weekly HIV pipeline expands
Business

CSPC and AstraZeneca establish biologics manufacturing joint venture in China

CSPC and AstraZeneca establish biologics manufacturing joint venture in China
Business

Novo Nordisk Q2'26: ZEUS failure overshadows obesity pipeline advances

Novo Nordisk Q2'26: ZEUS failure overshadows obesity pipeline advances
Business

Mironid raises USD 46m to advance first-in-class ADPKD therapy

Mironid raises USD 46m to advance first-in-class ADPKD therapy
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BioInvent wins FDA Fast Track for BI-1808 after encouraging ovarian cancer data
Regulatory & Policy

BioInvent wins FDA Fast Track for BI-1808 after encouraging ovarian cancer data

Sweden-based BioInvent International AB (Nasdaq Stockholm: BINV) announced receipt of US FDA Fast Track Designation for BI-1808, a first-in-class anti-tumor...

9h agoSino Bio's benmelstobart-anlotinib regimen adds new China indication in first-line squamous NSCLC
Regulatory & Policy

Sino Bio's benmelstobart-anlotinib regimen adds new China indication in first-line squamous NSCLC

China's National Medical Products Administration (NMPA) has approved a new first-line regimen for locally advanced or metastatic squamous non-small cell...

9h agoEU clears label expansion for Bavarian Nordic's Mpox vaccine to children as young as two
Regulatory & Policy

EU clears label expansion for Bavarian Nordic's Mpox vaccine to children as young as two

The European Commission has approved a label extension for Imvanex (MVA-BN), Denmark-based Bavarian Nordic's (OMX: BAVA) non-replicating smallpox and mpox...

12h agoReplimune secures accelerated approval for oncolytic viral therapy Tudriqev
Regulatory & Policy

Replimune secures accelerated approval for oncolytic viral therapy Tudriqev

The US FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy developed by...

12h agoTransThera wins first China approval in post-FGFR cholangiocarcinoma
Regulatory & Policy

TransThera wins first China approval in post-FGFR cholangiocarcinoma

China's National Medical Products Administration (NMPA) has granted conditional marketing approval to Yochanra (tinengotinib) tablets for adult patients...

1d agoTakeda ushers in the orexin era with landmark FDA approval
Regulatory & Policy

Takeda ushers in the orexin era with landmark FDA approval

The US FDA has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1) in adults, marking the first approval of an orexin receptor...

2d agoLexeo's PKP2 cardiomyopathy gene therapy adds RMAT status
Regulatory & Policy

Lexeo's PKP2 cardiomyopathy gene therapy adds RMAT status

New York-based Lexeo Therapeutics (Nasdaq: LXEO) announced that the US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to LX2020,...

2d agoModerna's mFlusiva becomes first mRNA influenza vaccine in US
Regulatory & Policy

Moderna's mFlusiva becomes first mRNA influenza vaccine in US

The US FDA has approved Mflusiva (mRNA-1010), Cambridge, Massachusetts-based Moderna's (Nasdaq: MRNA) mRNA-based seasonal influenza vaccine, for active...

2d ago
The AllSci BriefSystematic R&D and deal news. Daily.
Arrowhead nabs FDA priority review voucher for plozasiran
Regulatory & Policy

Arrowhead nabs FDA priority review voucher for plozasiran

Pasadena, California-based Arrowhead Pharmaceuticals (Nasdaq: ARWR) announced that it has signed an agreement to acquire a US FDA Rare Pediatric Disease...

3d agoXellSmart's off-the-shelf Parkinson's cell therapy gets FDA fast-track treatment
Regulatory & Policy

XellSmart's off-the-shelf Parkinson's cell therapy gets FDA fast-track treatment

China-based XellSmart Biopharmaceutical Co., Ltd. announced on July 28, 2026 that the US FDA has granted Fast Track Designation (FTD) to XS411, an...

3d agoFDA approves Pluvicto in earlier-stage prostate cancer, expanding Novartis's radioligand franchise
Regulatory & Policy

FDA approves Pluvicto in earlier-stage prostate cancer, expanding Novartis's radioligand franchise

The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with...

4d agoZai Lab's zoci takes FDA orphan drug designation for neuroendocrine carcinomas
Regulatory & Policy

Zai Lab's zoci takes FDA orphan drug designation for neuroendocrine carcinomas

Zai Lab (Nasdaq: ZLAB) announced receipt of US FDA orphan drug designation for zocilurtatug pelitecan (zoci, formerly ZL-1310), its delta-like ligand 3...

4d agoChina grants breakthrough status for InnoCare's orelabrutinib-mesutoclax combo in MZL
Regulatory & Policy

China grants breakthrough status for InnoCare's orelabrutinib-mesutoclax combo in MZL

China-based InnoCare Pharma (HKEX: 09969; SSE: 688428) announced that the orelabrutinib mesutoclax combination has been granted Breakthrough Therapy...

4d agoAravax secures FDA Fast Track designation for PVX108 peanut allergy immunotherapy
Regulatory & Policy

Aravax secures FDA Fast Track designation for PVX108 peanut allergy immunotherapy

Aravax, a clinical-stage biotechnology company headquartered in Melbourne, Australia and Oxford, UK, announced receipt of US FDA Fast Track Designation for...

4d agoLilly's olomorasib earns FDA Breakthrough Therapy designation for KRAS G12C pancreatic cancer
Regulatory & Policy

Lilly's olomorasib earns FDA Breakthrough Therapy designation for KRAS G12C pancreatic cancer

Eli Lilly and Company (NYSE: LLY) announced on August 3, 2026 that the US FDA has granted Breakthrough Therapy Designation (BTD) to olomorasib (LY3537982),...

5d ago