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Results For "USFDA"

1313 News Found

Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER
Drug Approval | November 23, 2025

Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER

Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis


FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients
Drug Approval | November 23, 2025

FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients

The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy


FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
Drug Approval | November 21, 2025

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

HER2-mutant NSCLC typically has a poor prognosis and limited treatment options


AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients
Drug Approval | November 21, 2025

AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients

The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study


Sudeep Pharma eyes Rs. 895 crore fundraising from debut on bourses
News | November 19, 2025

Sudeep Pharma eyes Rs. 895 crore fundraising from debut on bourses

The issue comprises a fresh issue of Rs. 95 crore and targeting a total raise of around Rs. 895 crore


Ingenus Pharma launches first FDA-approved generic version of Premarin
Drug Approval | November 18, 2025

Ingenus Pharma launches first FDA-approved generic version of Premarin

Conjugated Estrogens Tablets are indicated for moderate to severe menopausal symptoms, including hot flashes, and for the prevention of postmenopausal osteoporosis in women at significant risk


Briefs: Zydus, Divi's Laboratories and Relonchem
News | November 17, 2025

Briefs: Zydus, Divi's Laboratories and Relonchem

FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations


Indian pharma sector poised for a global leap beyond generics: K. Raja Bhanu, DG, PHARMEXCIL
News | November 17, 2025

Indian pharma sector poised for a global leap beyond generics: K. Raja Bhanu, DG, PHARMEXCIL

With US$ 30.46 billion in exports and robust manufacturing capabilities, the industry is poised to expand into high-value drugs while strengthening ESG and compliance standards