Drug Approval | August 06, 2025
AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients
The submission is supported by positive results from the Phase 3 AMPLIFY trial
The submission is supported by positive results from the Phase 3 AMPLIFY trial
These filings come after FDA issued its latest warning to patients and healthcare professionals about the serious dangers of compounded GLP-1 drugs
During Q1FY26, the company incurred Capex of ~Rs. 48.5 crores mainly towards capacity expansion, backward integration and finished formulation R&D
Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension
Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility
Granules India receives 1 observation from USFDA for Chantilly facility
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA
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