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Drug Approval Process

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3 ARTICLES

4d ago

Sacituzumab Tirumotecan With Keytruda Improves Progression-Free Survival in China Phase 3 Lung Cancer Trial

Company-reported results show higher tumor response alongside increased serious blood-related adverse events, a mix that will shape regulatory review and further development.

3 ARTICLES

last wk.

Kissei Tells Japan Doctors to Halt New Tavneos Use After 20 Deaths Reported

3 ARTICLES

4w ago

Roche Files MS Drug Fenebrutinib With Regulators Despite Trial Deaths

3 ARTICLES

last mo.

AstraZeneca’s Tozorakimab Hits Phase III Goal in COPD, Marking Third Positive Pivotal Trial

4 ARTICLES

2mo ago

DBV Technologies Files 2025 Annual Report, Extends Runway as 2026 Peanut Patch Filings Near

12 ARTICLES

2mo ago

Semaglutide Patent Expires in Brazil, Opening Door to Lower-Cost Rivals

3 ARTICLES

2mo ago

EMA Backs First Combined COVID-19 and Flu Vaccine for Over-50s in EU

4 ARTICLES

3mo ago

Sanofi’s Venglustat Notches Gaucher Type 3 Phase 3 Win, Misses Fabry Pain Endpoint

3 ARTICLES

3mo ago

EMA Panel Backs Conditional EU Approval for Rezurock in Chronic GvHD

3 ARTICLES

5mo ago

EU Regulator Backs Myqorzo for Obstructive Hypertrophic Cardiomyopathy

8 ARTICLES

5mo ago

Ianalumab Plus Eltrombopag Extends Disease Control in Phase 3 ITP Study Published in NEJM

4 ARTICLES

5mo ago

Padcev–Keytruda Cuts Recurrence and Death Risk in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

3 ARTICLES

7mo ago

Enhertu Delivers Pivotal Gains in Early HER2-Positive Breast Cancer

3 ARTICLES

7mo ago

CHMP Recommends Approval of Wayrilz for Refractory ITP in Adults

5 ARTICLES

8mo ago

FDA Clears Shot Version of Keytruda as EU Panel Backs Approval

10 ARTICLES

9mo ago

Mounjaro Rivals Trulicity in Cardiovascular Safety and Lowers All-Cause Mortality

4 ARTICLES

10mo ago

AstraZeneca’s Baxdrostat Delivers Significant Blood Pressure Reductions in Phase 3 Trial for Resistant Hypertension

Drug Approval Process

Sacituzumab Tirumotecan With Keytruda Improves Progression-Free Survival in China Phase 3 Lung Cancer Trial

Kissei Tells Japan Doctors to Halt New Tavneos Use After 20 Deaths Reported

Roche Files MS Drug Fenebrutinib With Regulators Despite Trial Deaths

AstraZeneca’s Tozorakimab Hits Phase III Goal in COPD, Marking Third Positive Pivotal Trial

DBV Technologies Files 2025 Annual Report, Extends Runway as 2026 Peanut Patch Filings Near

Semaglutide Patent Expires in Brazil, Opening Door to Lower-Cost Rivals

EMA Backs First Combined COVID-19 and Flu Vaccine for Over-50s in EU

Sanofi’s Venglustat Notches Gaucher Type 3 Phase 3 Win, Misses Fabry Pain Endpoint

EMA Panel Backs Conditional EU Approval for Rezurock in Chronic GvHD

EU Regulator Backs Myqorzo for Obstructive Hypertrophic Cardiomyopathy

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Drug Approval Process

Ianalumab Plus Eltrombopag Extends Disease Control in Phase 3 ITP Study Published in NEJM

Dyne’s DMD Drug Hits Primary Endpoint in DELIVER REC, Shows Functional Gains

Belite Bio’s Tinlarebant Cuts Stargardt Lesion Growth 36% in Phase 3 Trial

EMA Panel Backs Waskyra Gene Therapy for Wiskott‑Aldrich Syndrome

Padcev–Keytruda Cuts Recurrence and Death Risk in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

Enhertu Delivers Pivotal Gains in Early HER2-Positive Breast Cancer

CHMP Recommends Approval of Wayrilz for Refractory ITP in Adults

FDA Clears Shot Version of Keytruda as EU Panel Backs Approval

Mounjaro Rivals Trulicity in Cardiovascular Safety and Lowers All-Cause Mortality

AstraZeneca’s Baxdrostat Delivers Significant Blood Pressure Reductions in Phase 3 Trial for Resistant Hypertension

Never miss stories about

Drug Approval Process