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Results For "USFDA"

1135 News Found

USFDA issues final guidance on voluntary recalls
News | March 04, 2022

USFDA issues final guidance on voluntary recalls

The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem


USFDA refuses to grant EUA to Covaxin for padeatric use
News | March 04, 2022

USFDA refuses to grant EUA to Covaxin for padeatric use

Covaxin is not approved in the USA for any age group


Lupin receives USFDA approval for topical solution
Drug Approval | March 03, 2022

Lupin receives USFDA approval for topical solution

The product will be manufactured at Lupin’s facility in Pithampur, India


USFDA issues new clinical trial guidelines for cancer treatments
News | March 02, 2022

USFDA issues new clinical trial guidelines for cancer treatments

USFDA's industry recommendations and cancer Moonshot aim to improve lives of patients and their families


USFDA approves first generic version of Apokyn cartridges
Drug Approval | March 02, 2022

USFDA approves first generic version of Apokyn cartridges

TruPharma has commenced commercial marketing of Sage's approved generic cartridge product


Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review
Biotech | March 01, 2022

Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review

If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.


USFDA approves CITI Biopharma’s Vonjo
Drug Approval | March 01, 2022

USFDA approves CITI Biopharma’s Vonjo

Vonjo is the first approved therapy to specifically address the needs of adult cytopenic myelofibrosis patients


USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy
Biotech | February 25, 2022

USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy

Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases


Medtronic receives USFDA approval for InterStim X system to manage bladder and bowel control
Medical Device | February 23, 2022

Medtronic receives USFDA approval for InterStim X system to manage bladder and bowel control

New InterStim X system provides 10 to 15 years of battery life without the need to recharge


Zydus receives USFDA approval for Dapagliflozin tablets
Drug Approval | February 23, 2022

Zydus receives USFDA approval for Dapagliflozin tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad