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Philogen completes patient enrollment of Phase III FIBROSARC trial in Soft Tissue Sarcoma
News | February 06, 2025

Philogen completes patient enrollment of Phase III FIBROSARC trial in Soft Tissue Sarcoma

These results represent critical milestones for Philogen, as Fibromun has the potential to become second product to successfully complete multinational clinical trials with registration potential


Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
Drug Approval | February 03, 2025

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025


Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer
Drug Approval | February 01, 2025

Roche receives FDA approval for the first companion diagnostic to identify patients ultralow metastatic breast cancer

The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.


Strides reports 14.6% growth in Q3 FY25 revenue
News | January 31, 2025

Strides reports 14.6% growth in Q3 FY25 revenue

EBITDA grew 46.9% YoY to Rs. 210.3 crore with EBITDA margin at 18.2%, grew 401 bps YoY and the reported PAT at Rs. 90 crore


Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS
Drug Approval | January 23, 2025

Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS

The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS


Strides receives USFDA approval for Acetaminophen and Ibuprofen Tablets
Drug Approval | January 21, 2025

Strides receives USFDA approval for Acetaminophen and Ibuprofen Tablets

The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru


Briefs: Cipla and IOL Chemicals and Pharmaceuticals
News | January 21, 2025

Briefs: Cipla and IOL Chemicals and Pharmaceuticals

Mesalazine is used to treat inflammatory bowel disease


Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles


Bajaj Healthcare receives exclusive rights for manufacturing, distribution & sales of finished formulation of Magnesium L Threonate
News | January 17, 2025

Bajaj Healthcare receives exclusive rights for manufacturing, distribution & sales of finished formulation of Magnesium L Threonate

The brand Magtein by Threotech has a sales value of approximately US $438 million


FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
Drug Approval | January 17, 2025

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA

Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations