News Alerts – Generics

***Click on January tab to see sample of news list in decending order by date….

 

Content below this line is not intended to be part of actual page. Sample content storage only.

This section is a visual of how many months can fit into a tabbed section… If we abbreviate the names of the months, we’ll could fit all 12 months.

Biosimilars

Discontinuations

Generics

New Drugs

New Drug Indications

 

This section is only here until the January data links can be transferred or deleted at a later time…

January 31

Avtozma® Injection – Biosimilar To Actemra®
www.celltrionusa.com/board/newslist/30

January 17

Datroway® For Previously Treated Metastatic HR-Positive, HER2-Negative Breast Cancer
www.daiichisankyo.com/files/news/pressrelease/pdf/202501/20250117_E.pdf
www.astrazeneca.com/media-centre/press-releases/2025/calquence-combination-approved-in-us-for-1l-mcl.html

January 22

Grafapex™ Injection For Allogeneic Hematopoietic Stem Cell Transplantation Patients With Acute Myeloid Leukemia Or Myelodysplastic Syndrome
www.medexus.com/en_US/news-media/press-releases/detail/176/medexus-announces-fda-approval-of-grafapex-treosulfan-for

January 30

Journavx™ Tablets For Moderate-To-Severe Acute Pain
https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class

January 15

Niktimvo™ Injection 9 mg and 22 mg – New Vial Sizes
https://ir.syndax.com/news-releases/news-release-details/incyte-and-syndax-announce-us-food-and-drug-administration-fda

Omvoh® Injection For Crohn’s Disease – New Indication
https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohr-mirikizumab-mrkz-crohns-disease

January 17

Calquence® Tablets + Chemoimmunotherapy For Previously Untreated Mantle Cell Lymphoma – New Indication
www.astrazeneca.com/media-centre/press-releases/2025/calquence-combination-approved-in-us-for-1l-mcl.html

Lumakras® Tablets + Vectibix® For Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer – New Indication
https://investors.amgen.com/news-releases/news-release-details/fda-approves-lumakrasr-sotorasib-combination-vectibixr

January 21

Spravato® Nasal Spray (C-III)-The First & Only Monotherapy For Treatment-Resistant Depression – New Indication
www.investor.jnj.com/news/news-details/2025/Spravato-esketamine-approved-in-the-U.S.-as-the-first-and-only-monotherapy-for-adults-with-treatment-resistant-depression/default.aspx

January 26

Leqembi® For Early Alzheimer’s Disease – New Dosing Regimen
https://media-us.eisai.com/2025-01-26-FDA-Approves-Leqembi-R-lecanemab-irmb-IV-Maintenance-Dosing-for-the-Treatment-of-Early-Alzheimers-Disease
https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-lecanemab-irmb-iv-maintenance-dosing

January 27

Enertu® Injection – First HER2-Directed Therapy For HER2-Low Or HER2-Ultralow Metastatic Breast Cancer Following Disease Progression After One Or More Endocrine Therapies – New Indication
www.daiichisankyo.com/files/news/pressrelease/pdf/202501/20250127_E.pdf
www.astrazeneca-us.com/media/press-releases/2025/Enertu-fam-trastuzumab-deruxtecan-nxki-approved-in-the-us-as-first-her2-directed-therapy-for-patients-with-her2-low-or-her2-ultralow-metastatic-breast-cancer-following-disease-progression-after-one-or-more-endocrine-therapies.html

January 28

Ozempic® Injection – 3 New Indications
www.novonordisk-us.com/media/news-archive/news-details.html?id=915253