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Results For "USFDA"

1316 News Found

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin
Drug Approval | September 28, 2024

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression


Zydus receives USFDA final approval for Enzalutamide Capsules, 40 mg
Drug Approval | September 28, 2024

Zydus receives USFDA final approval for Enzalutamide Capsules, 40 mg

Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad


Alembic receives USFDA final approval for Paliperidone ER tablets
News | September 27, 2024

Alembic receives USFDA final approval for Paliperidone ER tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia


Lupin receives USFDA approval for Bumetanide Injection
Drug Approval | September 19, 2024

Lupin receives USFDA approval for Bumetanide Injection

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.


Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis
Drug Approval | September 19, 2024

Roche receives USFDA approval for Ocrevus Zunovo for treatment of progressive multiple sclerosis

This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally


Strides receives USFDA approval for Fluoxetine Tabs 60 mg
Drug Approval | September 16, 2024

Strides receives USFDA approval for Fluoxetine Tabs 60 mg

Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules


USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations
Drug Approval | September 14, 2024

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices


USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington
Drug Approval | September 11, 2024

USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington

Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding


Granules India’s Gagillapur facility completes USFDA inspection with six observations
Drug Approval | September 09, 2024

Granules India’s Gagillapur facility completes USFDA inspection with six observations

The recent inspection covered both cGMP and PAI processes


Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg
Drug Approval | September 06, 2024

Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug