Drug Approval | September 18, 2024
Briefs: Eugia Steriles and Shelter Pharma
Eugia Steriles receives EIR from USFDA for new injectable facility
Eugia Steriles receives EIR from USFDA for new injectable facility
At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules
India's bio economy has experienced remarkable growth, skyrocketing from US $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030
The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
Mirabegron Extended-Release Tablets, 50 mg is a generic equivalent of Myrbetriq® Extended-Release Tablets, 50 mg of Astellas Pharma Global Development
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