Drug Approval | July 30, 2024
Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
The inspection was concluded with two 483 observations
Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)
Contepo offers a unique mechanism of action and has the potential to address increasing antibiotic resistance and gaps in the current antibiotic treatment landscape
Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
The pooled prevalence of GERD in the Indian population is 15.6 %
Directs officials to ensure that challenges hampering their effective implementation are resolved early in coordination with states
Dr. Roopal Thakkar joined Abbott/AbbVie in 2003 as part of the Physician Development Program
Imfinzi also recommended for patients with mismatch repair deficient disease
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