Drug Approval | September 28, 2024
Zydus receives USFDA final approval for Enzalutamide Capsules, 40 mg
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
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
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