-
US FDA approves Accord BioPharma's denosumab biosimilars Osvyrti and Jubereq
21 Nov 2025 13:21 GMT
… the US Food and Drug Administration (FDA) approval of Osvyrti ( … Osvyrti is indicated for treatment of postmenopausal women with … from two trials: a Phase I trial and a … and Camcevi (leuprolide) 42 mg injectable emulsion.
Intas Pharmaceuticals, Ltd. has …
-
Remeasuring Biotech Pipelines: The Valuation Signal Investors Have Been Waiting For
20 Nov 2025 13:30 GMT
… and price biotech innovation earlier in the drug-development lifecycle … trial initiations highlight the expanding potential of targeted treatments … which was developed with Medicines for Malaria Venture, … ), in combination with leuprolide and as monotherapy, …
-
Accord BioPharma, Inc. Announces FDA Approval of Denosumab Biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu)
20 Nov 2025 13:28 GMT
… division of Intas Pharmaceuticals, Ltd., focused … S. Food and Drug Administration (FDA) approval of … trastuzumab), and CAMCEVI® (leuprolide) 42 mg injectable emulsion … trials.
INDICATIONS
OSVYRTI is a RANK ligand (RANKL) inhibitor indicated for treatment …
-
Health Canada approves AbbVie’s Lupron Depot new strength for the treatment of advanced prostate cancer
19 Nov 2025 09:31 GMT
… month 45mg Lupron Depot (leuprolide acetate for extended-release … advance and introduce new treatment options, ensuring better outcomes … Depot is a hormonal medication approved by Health Canada … discover and deliver innovative medicines and solutions that solve …
-
<![CDATA[Dr Freedland on the Rationale Behind the EMBARK Trial in Prostate Cancer]]>
19 Nov 2025 01:17 GMT
… EMBARK trial (NCT02319837) evaluating overall survival with enzalutamide (Xtandi) plus leuprolide in … Lilly, Johnson & Johnson Innovative Medicine (formerly Janssen), Merck, Novartis, Pfizer …
-
LUPRON DEPOT® new strength receives Health Canada Approval for the Treatment of Advanced Prostate Cancer
17 Nov 2025 21:02 GMT
… (leuprolide acetate … treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug … medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments … medicines in multiple clinical trials …
-
Zydus receives final approval from USFDA for Leuprolide Acetate injection, 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial
15 Nov 2025 09:15 GMT
… Food and Drug Administration (USFDA) for Leuprolide Acetate injection, … the palliative treatment of advanced prostatic cancer. Leuprolide Acetate …
Keywords
ZydusLifesciences
INE010B01027
Pharmaceuticals
USFDA
FinalApproval
LeuprolideAcetateInjection
-
Zydus Lifesciences secures USFDA approval for Leuprolide Acetate Injection
14 Nov 2025 12:01 GMT
… United States Food and Drug Administration for Leuprolide Acetate Injection, 14 mg … used therapy in the palliative treatment of advanced prostate cancer.
The … formulations and regulated market supplies.
Leuprolide Acetate continues to hold a …
-
Zydus Lifesciences gets USFDA nod for Leuprolide Acetate injection
14 Nov 2025 10:15 GMT
… its generic Leuprolide Acetate injection. This medication is used for palliative treatment of … will manufacture the injections. The drug had significant annual sales in …
-
40% boost in survival for men: Pairing two cancer drugs may reduce prostate cancer death risk
10 Nov 2025 05:10 GMT
… EMBARK trial, published in the The New England Journal of Medicine, … two drugs, namely Leuprolide (a testosterone-suppressing injection) and Enzalutamide (a pill that … conversation with their doctors, are better positioned. Moreover, treatments that prolong “ …