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ACHEMA MIDDLE EAST 2026
17TH Global Drug Delivery & Formulation Summit 2026

FDA Approvals

Chinas National Medical Products Administration Approves Harvoni for Treatment of Chronic Hepatitis C Virus Genotype

FDA Approvals
Gilead Sciences announced that the National Medical Products Administration (NMPA) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) in China for the treatment of...

FDA approves Roches Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer

FDA Approvals
Roche announced that the US FDA approved Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with...

Shire Receives European Approval for TAKHZYRO (lanadelumab) subcutaneous injection for the Preventive Treatment of Hereditary Angioedema

FDA Approvals
Shire plc the leading global biotechnology company focused on rare diseases, announced that the European Commission (EC) has granted Marketing Authorisation for TAKHZYRO™ (lanadelumab)...

European Commission Approves Mercks DELSTRIGO

FDA Approvals
Merck, known as MSD outside the United States and Canada, announced that the EC has approved DELSTRIGO™ and PIFELTRO™ for the treatment of HIV-1...

Sandoz receives eighth European Commission approval for a biosimilar with Ziextenzo

FDA Approvals
Sandoz, a Novartis division and the pioneer and global leader in biosimilars, announced that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo®...

FDA Approves First Drug Using the Recombinant Factor C Assay for Endotoxin Testing

Drug Development
Lonza announced that the recombinant Factor C Assay has been used for endotoxin testing of Eli Lilly’s Emgality™ , the first drug approved by...

European Commission has granted Marketing Authorization for Vertex’s SYMKEVI

FDA Approvals
Vertex Pharmaceuticals Limited, announced that the European Commission has granted Marketing Authorization for SYMKEVI in a combination regimen with ivacaftor for the treatment of...

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