Regulatory & Policy

Systematic, data-driven science coverage · Saturday, September 12, 2026
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Insilico’s rentosertib becomes first AI-discovered drug to enter Phase III

Insilico’s rentosertib becomes first AI-discovered drug to enter Phase III
Regulatory & Policy

Bayer’s Hyrnuo joins Boehringer’s Hernexeos in first-line HER2-mutant NSCLC

Bayer’s Hyrnuo joins Boehringer’s Hernexeos in first-line HER2-mutant NSCLC
Development

Disc Medicine’s DISC-3405 reduces phlebotomy needs in Phase II polycythemia vera trial

Disc Medicine’s DISC-3405 reduces phlebotomy needs in Phase II polycythemia vera trial
Development

FDA pauses enrollment in Biohaven’s opakalim trials; pivotal readout remains on track

FDA pauses enrollment in Biohaven’s opakalim trials; pivotal readout remains on track
Development

AbbVie's atogepant meets primary endpoint in Phase III menstrual migraine trial

AbbVie's atogepant meets primary endpoint in Phase III menstrual migraine trial
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FDA grants Fast Track Designation to Sobi's pacritinib for VEXAS syndrome
Regulatory & Policy

FDA grants Fast Track Designation to Sobi's pacritinib for VEXAS syndrome

Swedish Orphan Biovitrum AB (Stockholm: SOBI), operating through its North American affiliate Sobi North America, announced that the US FDA has granted Fast...

1d agoRoche moves Enspryng toward first approved MOGAD therapy
Regulatory & Policy

Roche moves Enspryng toward first approved MOGAD therapy

Roche (SIX: RO; OTCQX: RHHBY) announced a US FDA Priority Review award for a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab),...

2d agoBayer’s Hyrnuo joins Boehringer’s Hernexeos in first-line HER2-mutant NSCLC
Regulatory & Policy

Bayer’s Hyrnuo joins Boehringer’s Hernexeos in first-line HER2-mutant NSCLC

The US FDA has granted accelerated approval to Hyrnuo (sevabertinib) for the first-line treatment of adults with locally advanced or metastatic non-squamous...

2d agoAlebund gains FDA IND clearance for IgA-cleaving AP308 in IgA nephropathy
Regulatory & Policy

Alebund gains FDA IND clearance for IgA-cleaving AP308 in IgA nephropathy

Alebund Pharmaceuticals (HKEX: 09637) received US FDA clearance of its investigational new drug (IND) application for AP308, an engineered recombinant IgA...

3d agoInnoCare gains China IND clearance for PSMA/STEAP1 bispecific ADC ICP-B381
Regulatory & Policy

InnoCare gains China IND clearance for PSMA/STEAP1 bispecific ADC ICP-B381

China's drug regulator has cleared InnoCare Pharma (HKSE: 9969) to begin clinical testing of ICP-B381, a bispecific antibody-drug conjugate (ADC) designed...

3d agoIntellia’s one-shot CRISPR therapy gets March 2027 FDA decision date
Regulatory & Policy

Intellia’s one-shot CRISPR therapy gets March 2027 FDA decision date

Cambridge, Massachusetts-based Intellia Therapeutics, Inc. (Nasdaq: NTLA) announced that the US FDA has accepted its Biologics License Application (BLA) and...

4d agoFDA approves AZ’s Etcamah for pre-progression switch in HR+ breast cancer
Regulatory & Policy

FDA approves AZ’s Etcamah for pre-progression switch in HR+ breast cancer

AstraZeneca has received accelerated approval from the US FDA for Etcamah (camizestrant), an oral selective estrogen receptor degrader (SERD), in...

4d agoAcepodia wins FDA clearance for dual-payload GPC3 ADC in liver cancer
Regulatory & Policy

Acepodia wins FDA clearance for dual-payload GPC3 ADC in liver cancer

California- and Taiwan-based Acepodia (TWSE: 6976) has received US FDA clearance to begin Phase I testing of ACE723, a GPC3-targeted dual-payload...

Sep 4
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FDA requests public input on botanical drug product development pathways
Regulatory & Policy

FDA requests public input on botanical drug product development pathways

The FDA has issued a Request for Information (RFI) seeking public comment on how to advance the development of FDA botanical drug products — therapeutics...

Sep 4China approves Milestone/Everest's Cardamyst nasal spray for acute PSVT
Regulatory & Policy

China approves Milestone/Everest's Cardamyst nasal spray for acute PSVT

China's National Medical Products Administration (NMPA) has approved Cardamyst (etripamil) nasal spray for the treatment of paroxysmal supraventricular...

Sep 4FDA approves Zanvastro as first disease-modifying treatment for Alexander disease
Regulatory & Policy

FDA approves Zanvastro as first disease-modifying treatment for Alexander disease

The US FDA has approved Zanvastro (zilganersen), an antisense oligonucleotide (ASO) targeting glial fibrillary acidic protein (GFAP) mRNA, for the treatment...

Sep 4China approves two homegrown long-acting RSV antibodies for infants
Regulatory & Policy

China approves two homegrown long-acting RSV antibodies for infants

China's National Medical Products Administration (NMPA) has approved two domestically developed long-acting monoclonal antibodies for the prevention of...

Sep 4Hengrui files Kailera-partnered oral GLP-1 for China approval in obesity and diabetes
Regulatory & Policy

Hengrui files Kailera-partnered oral GLP-1 for China approval in obesity and diabetes

China's drug regulator has accepted a marketing authorization application for HRS-7535 tablets, an oral small-molecule glucagon-like peptide-1 receptor...

Sep 3Kali, Sanofi's tri-specific T-cell engager cleared for US study in rheumatoid arthritis
Regulatory & Policy

Kali, Sanofi's tri-specific T-cell engager cleared for US study in rheumatoid arthritis

California-based Kali Therapeutics announced US FDA clearance of an investigational new drug (IND) application for KT501, a trispecific B-cell–depleting...

Sep 3NMPA accepts Hansoh’s B7-H3 ADC HS-20093 in post-platinum SCLC
Regulatory & Policy

NMPA accepts Hansoh’s B7-H3 ADC HS-20093 in post-platinum SCLC

China's National Medical Products Administration (NMPA) has accepted a biologics license application from Hansoh Pharmaceutical Group Company Limited (HKEX:...

Sep 3