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1670 News Found

Privi Speciality Chemicals gets USFDA certificate for camphor product
News | October 11, 2024

Privi Speciality Chemicals gets USFDA certificate for camphor product

The company can now expand its business horizon into the area of pharmaceutical applications in the USA


Briefs: NATCO Pharma, Mylan Pharmaceuticals, Novo Nordisk and Alembic Pharmaceuticals
News | October 09, 2024

Briefs: NATCO Pharma, Mylan Pharmaceuticals, Novo Nordisk and Alembic Pharmaceuticals

Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic


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


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


Aurobindo Pharma receives USFDA approval for Cephalexin Tablets
Drug Approval | October 02, 2024

Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

The product is expected to be launched in Q3FY25


Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Drug Approval | October 02, 2024

Zydus receives tentative approval from USFDA for Enzalutamide Tablets

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad


Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir
News | October 02, 2024

Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir

Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022


Apitoria Pharma gets Form 483 with 10 observations from USFDA
Drug Approval | October 01, 2024

Apitoria Pharma gets Form 483 with 10 observations from USFDA

The observations are of procedural in nature and will be responded to within the stipulated time


USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
Drug Approval | September 30, 2024

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations