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Results For "ANDA"

2123 News Found

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate
Drug Approval | October 16, 2024

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally


Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3
Drug Approval | October 14, 2024

Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3

Indoco is comprehensively working on the remedial action plan


Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP
News | October 14, 2024

Indian drug regulator recommends Wockhardt's Miqnaf for treatment of CABP

Wockhardt's yet another novel antibiotic Miqnaf receives favourable recommendation from Subject Expert Committee of CDSCO


Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg
Drug Approval | October 11, 2024

Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg

Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad


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