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Results For "ANDA"

3109 News Found

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


WHO declares India has eliminated Trachoma as a public health problem in 2024
Healthcare | October 10, 2024

WHO declares India has eliminated Trachoma as a public health problem in 2024

WHO estimates suggest that 150 million people worldwide are affected by Trachoma


India’s emergence as a hub for affordable medicines is commendable: Dr. Jitendra Singh
News | October 10, 2024

India’s emergence as a hub for affordable medicines is commendable: Dr. Jitendra Singh

We now rank 3rd in pharmaceutical production by volume and 14th by value


Aster implements India’s first IOeRT for cancer care
Healthcare | October 09, 2024

Aster implements India’s first IOeRT for cancer care

To set a new standard in oncology, offering highly targeted radiation therapy that improves treatment precision, and accelerates recovery for cancer patients


Calquence granted priority review in US for patients with untreated mantle cell lymphoma
Drug Approval | October 06, 2024

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy


Biocon Biologics refinances US$ 1.1 billion debt through USD bonds, new syndicated facility
News | October 04, 2024

Biocon Biologics refinances US$ 1.1 billion debt through USD bonds, new syndicated facility

US$ 800 million senior secured notes, the largest high yield debut USD bond issuance from India in the last 10 years


Shilpa Pharma Lifesciences receives CEP from EDQM for API, Desmopressin
Drug Approval | October 04, 2024

Shilpa Pharma Lifesciences receives CEP from EDQM for API, Desmopressin

This is used to treat central diabetes insipidus and bedwetting


Piramal Pharma releases Sustainability Report FY 2023-24
News | October 04, 2024

Piramal Pharma releases Sustainability Report FY 2023-24

The report highlights Piramal Pharma’s approach across four key strategic pillars: Responsible Operations, Business Resilience, Customer Centricity, and Quality & Excellence


Alembic receives USFDA final approval for Alcaftadine Ophthalmic Solution, 0.25% (OTC)
Drug Approval | October 04, 2024

Alembic receives USFDA final approval for Alcaftadine Ophthalmic Solution, 0.25% (OTC)

Alcaftadine Ophthalmic Solution, 0.25% (OTC) is used to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander


Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets
Drug Approval | October 03, 2024

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures