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Results For "FDA"

2062 News Found

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA
Drug Approval | September 29, 2024

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)


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


FDA approves Bristol Myers Squibb’s Cobenfy
Drug Approval | September 28, 2024

FDA approves Bristol Myers Squibb’s Cobenfy

A first-in-class muscarinic agonist for the treatment of schizophrenia in adults


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


FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy
Drug Approval | September 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous


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