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Results For "Food-and-Drug-Administration"

1066 News Found

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer
Drug Approval | May 29, 2025

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition


Zydus receives final approval from USFDA for Isotretinoin Capsules USP
Drug Approval | May 24, 2025

Zydus receives final approval from USFDA for Isotretinoin Capsules USP

Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne


Venus Remedies joins United Nations Global Compact
Sustainability | May 21, 2025

Venus Remedies joins United Nations Global Compact

This global affiliation marks a critical step in the company’s mission to create long-term value through ethical practices, scientific innovation, and inclusive healthcare delivery


Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection
Drug Approval | May 14, 2025

Caplin Steriles gets USFDA approval for Haloperidol Decanoate Injection

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy


Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity
News | May 13, 2025

Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity

Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease


Zydus receives final approval from USFDA for Glatiramer Acetate Injection
Drug Approval | May 12, 2025

Zydus receives final approval from USFDA for Glatiramer Acetate Injection

Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes


Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM
News | May 08, 2025

Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM

The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets


Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma
News | May 06, 2025

Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma

IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma