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17TH Global Drug Delivery & Formulation Summit 2026

FDA Approvals

The EU approves Tagrisso for 1st-line treatment of EGFR-mutated non-small cell lung cancer

FDA Approvals
The European Commission has granted marketing authorisation for Tagrisso (osimertinib) as monotherapy for the 1st-line treatment of adult patients with locally-advanced or metastatic non-small...

OLUMIANT® (baricitinib) 2-mg Tablets gets FDA approval to treat adult patients with moderately to severely active Rheumatoid Arthritis

FDA Approvals
Eli Lilly and Company and Incyte Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT®...

Lupin’s Nagpur facility US FDA inspection concluded with no observations

FDA Approvals
Pharma major Lupin announced the successful completion of an inspection carried out by the US FDA at its Nagpur facility. The inspection concluded without...

U.S. FDA Approves Expanded Indication for Truvada for Reducing the Risk of Acquiring HIV-1 in Adolescents

FDA Approvals
Gilead Sciences, Inc. announced that the U.S. FDA has approved once-daily oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex...

Tasigna drug to treat children with rare form of leukemia receives FDA approval: Novartis

FDA Approvals
Novartis announced that the US FDA expanded the indication for Tasigna  (nilotinib) to include treatment of first- and second-line pediatric patients one year of...

Personalised medicines, intelligent packaging and FDA deadlines seen as major trends for pharma packaging in 2018

FDA Approvals
Pharmapack Europe (#pharmapackeu) – organised by UBM – closed its most exciting edition to date, taking place at Paris Expo, Porte De Versailles on...

FDA Approves Avycaz for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

FDA Approvals
Allergan plc , a leading global pharmaceutical company, announced that the U.S. FDA has approved Allergan's supplemental New Drug Application (sNDA) to expand the...

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