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US FDA

US FDA inspects Vishakhapatnam facility of Solara Active Pharma

US FDA inspects Vishakhapatnam facility of Solara Active Pharma

Mon, May 20, 2024

The US FDA agency with their designated investigator inspected the facility from 14th to 17th May.

Lupin trades flat after launch of Bromfenac Ophthalmic Solution

Lupin trades flat after launch of Bromfenac Ophthalmic Solution

Wed, Jan 10, 2024

Lupin said that it was the exclusive first-to-file for Bromfenac Ophthalmic Solution, 0.07%, and is eligible for 180-day exclusivity.

First chikungunya vaccine, Ixchiq, approved by US FDA

First chikungunya vaccine, Ixchiq, approved by US FDA

Fri, Nov 10, 2023

Ixchiq, the first chikungunya vaccine, has been approved by the US Food and Drug Administration (FDA) for individuals 18 years of age and older who are at increased risk of exposure to mosquito-borne virus.

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US FDA approves 1st Alzheimer's drug, Leqembi, that can slow disease

US FDA approves 1st Alzheimer's drug, Leqembi, that can slow disease

Fri, Jul 07, 2023

In a first, the US Food and Drug Administration (FDA) has granted full approval to a drug to slow down disease progression in adult patients with Alzheimer's disease. Alzheimer's disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and eventually, the ability to carry out simple tasks.

USFDA puts on hold Sun Pharma trials on dermatological drug

USFDA puts on hold Sun Pharma trials on dermatological drug

Tue, May 02, 2023

The drug major on Tuesday said it had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose in one of the long-term Open Label Extension (OLE) studies.

Sun Pharma shares drop 2% after shipments from Mohali facility halted; should you buy, sell or hold?

Sun Pharma shares drop 2% after shipments from Mohali facility halted; should you buy, sell or hold?

Mon, Apr 24, 2023

Sun Pharma share price: These actions include retaining an independent Current Good Manufacturing Practice expert to conduct batch certifications of drugs manufactured at the Mohali facility.

Should You Buy, Sell Or Hold Cipla After Fall In Share Price? Watch The Triggers Behind The Fall Here

Should You Buy, Sell Or Hold Cipla After Fall In Share Price? Watch The Triggers Behind The Fall Here

Mon, Feb 20, 2023

What are the objections of US FDA on Cipla's plant? How much shares fell due to US FDA objections? Know full details from Nupur.

US FDA Issues Import Alert On Sun Pharma's Halol Facility

US FDA Issues Import Alert On Sun Pharma's Halol Facility

Fri, Dec 09, 2022

The US Food and Drug Administration (FDA) had listed Sun Pharmaceutical Industries Ltd's Halol facility in Gujarat under an import alert, the company said today. What is the impact of import alert on the plant? Know what are the views of brokerages on Sun Pharma from Nupur.

Negative News For Lupin, Received Warning Letter For Tarapur Plant From US FDA

Negative News For Lupin, Received Warning Letter For Tarapur Plant From US FDA

Thu, Sep 29, 2022

Received warning letter for Tarapur plant from US FDA. The plant was investigated from March 22 to April 4. Will address US FDA concerns soon: Lupin.

Which Companies Are On The Radar Of The US FDA? Watch This Video For Details

Which Companies Are On The Radar Of The US FDA? Watch This Video For Details

Thu, Sep 01, 2022

How many companies have raised objections? Which companies are on the radar of the US FDA? Know full details from Nupur.

SEBI issues warning letter to Aurobindo Pharma over US FDA audit

SEBI issues warning letter to Aurobindo Pharma over US FDA audit

Mon, Jun 27, 2022

The Securities and Exchange Board of India (SEBI) on Monday issued a warning letter to pharmaceutical manufacturing company Aurobindo Pharma. The warning letter has been issued for not sharing complete information related to the United States Food and Drug Administration (US FDA). Zee Business report.

Setback for Pfizer, US FDA issues warning letter to company's Vizag plant

Setback for Pfizer, US FDA issues warning letter to company's Vizag plant

Wed, Apr 01, 2020

Pharmaceutical major Pfizer has been issued a warning letter by US FDA on issues of failed sterility test, Environmental Monitoring Program and data integrity remediation issues; Warning letter was issued on 25 March, against the Vishakhapattanam plant of the company

Coronavirus cure: Hydroxychloroquine, chloroquine use to treat COVID-19 in US allowed by FDA

Coronavirus cure: Hydroxychloroquine, chloroquine use to treat COVID-19 in US allowed by FDA

Tue, Mar 31, 2020

US Food and Drug Administration (FDA) has approved the use of two anti-malaria drugs to treat patients infected by the coronavirus. The US Department of Health and Human Services (HHS) in a statement on Sunday said that chloroquine and hydroxychloroquine could be prescribed to teens and adults with COVID-19 "as appropriate, when a clinical trial is not available or feasible

Divi's laboratories drops over 10% on USFDA reports

Divi's laboratories drops over 10% on USFDA reports

Mon, Dec 26, 2016

Pharmaceutical major Divi's Laboratories Ltd continued to fall on Monday with the stock cracking over 10%, or Rs 85.75 per share.

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