Drug Approvals
Page 4 • 11 itemsTrack global drug approvals & regulatory decisions. Gain critical intelligence on new therapies, market access, and competitive landscapes for pharma BD.
Sanofi's Tzield Receives FDA Approval for Children as Young as 1 Year to Delay Type 1 Diabetes Progression
FDA approves Sanofi's Tzield for children aged 1+ with stage 2 type 1 diabetes, marking the first disease-modifying therapy for this pediatric population.
Leerink Partners Initiates Medincell Coverage with Outperform Rating Following UZEDY Risperidone LAI FDA Approvals
Leerink Partners initiates Medincell coverage with Outperform rating as UZEDY risperidone LAI gains FDA approval for schizophrenia and bipolar disorder treatment.
![EMA Conditional Approval 2026: Insights from [Drug Name] Case Study](/uploads/articles/ema-conditional-approval-drugname-market-access-2026.webp)
EMA Conditional Approval 2026: Insights from [Drug Name] Case Study
This article delves into the EMA Conditional Approval 2026, highlighting key insights from the [Drug Name] case study for [indication] and its significance.
EMA Conditional Approval Pathway: Linvoseltamab and Oncology Access in EU
This article delves into the EMA's Conditional Approval Pathway, focusing on Linvoseltamab and its impact on oncology access across the European Union.
EMA Conditional Approval Oncology: What You Need to Know in 2026
In 2026, learn about the EMA's Conditional Approval process for oncology drugs, focusing on innovative treatments like XYZ for cancer patients.
CHMP Positive Opinions Diabetes Drugs: What You Need to Know Q3 2026
In Q3 2026, the CHMP issued positive opinions for key diabetes drugs, including Ozempic and Jardiance, highlighting advancements in diabetes management.
EMA Drug Patent Cliff 2026: Major European Pharmaceutical Exclusivities Set to Expire
Multiple high-cost EMA-approved drugs lose exclusivity in 2026, enabling generic competition and expanded patient access across Europe's healthcare systems.
EMA CHMP Recommends 6 New Medicines for Approval Including Treatments for Menopause, Liver Disease, and Rare Disorders
European Medicines Agency's CHMP recommends 6 new medicines for marketing authorization, covering menopausal symptoms, liver disease, and rare genetic disorders.
EMA Recommends Adstiladrin Gene Therapy for Bladder Cancer Treatment in March 2026
EMA's CHMP recommends conditional approval for Adstiladrin gene therapy to treat BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
EMA Approves Hanmi Pharmaceutical's HMPL-523 Herbal Medicine for Alzheimer's Disease Treatment
European Medicines Agency grants marketing authorization for HMPL-523, marking first herbal medicine approval for mild to moderate Alzheimer's disease treatment.
Beamion's Zongertinib Receives FDA Accelerated Approval for HER2-Mutant NSCLC as LUNG-1 Study Results Published in NEJM
Beamion's zongertinib gains FDA accelerated approval for HER2-mutant NSCLC treatment following breakthrough therapy designation and NEJM publication.