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usfda news

India's next pharmaceutical revolution

Indian companies are beginning to invest in the riskiest part of pharmaceutical science: discovering entirely new medicines.
Published on Jul 03, 2026 08:24 am IST

Sun Pharma's Taro recalls over 17,000 units of antifungal shampoo in US

The company is recalling the affected lot due to "Failed Impurity/Degradation specifications," the USFDA stated.
Published on Dec 25, 2025 04:29 pm IST

US drug body approves 1st over-the-counter opioid overdose reversal drug Narcan

The overdose-reversal drug Narcan is displayed.
Published on Mar 29, 2023 07:10 pm IST

Tamil Nadu firm told to suspend eye drops’ manufacturing

Tamil Nadu’s Drug Controller and members from the CDSCO carried out an inspection of the Chennai-based Global Pharma Healthcare from 7pm on Friday to 2am on Saturday. (ANI)
Updated on Feb 05, 2023 09:31 am IST

US approves new antibody treatment -- for arthritic cats

Overall, the cats in the treatment group had better assessment scores than those who received placebos during randomized clinical trials.
Published on Jan 14, 2022 03:17 am IST

J&J vaccine gets additional warning on bleeding aide effect

J&J said in a statement that “individuals who have been previously diagnosed with ITP should talk to their health-care provider regarding the risk of ITP and the potential need for platelet monitoring following vaccination.”
Published on Jan 13, 2022 10:56 am IST

ChemoCentryx's avacopan, used to treat rare autoimmune disease, gets approval

US health agency approved avacopan, which will be available under brand name Tavneos in the next few weeks, will have a wholesale price of between $150,000 and $200,000 per patient per year. 
Published on Oct 08, 2021 10:42 pm IST

Moderna says has completed filing process for full approval to its Covid vaccine

Moderna Covid-19 vaccine (AP)
Published on Aug 25, 2021 09:08 pm IST

White House welcomes FDA's full approval for Pfizer's Covid-19 vaccine

Pfizer Covid-19 vaccine (Reuters/File Photo)
Published on Aug 23, 2021 11:25 pm IST

News updates from HT: Pfizer's Covid-19 vaccine receives full approval from FDA

Pfizer's Covid-19 vaccine (Reuters)
Published on Aug 23, 2021 08:56 pm IST

Glenmark Pharma gets USFDA nod for inhalation product

Quoting IQVIA sales data for the 12 months period ending April 2021, the Brovana Inhalation Solution, 15 mcg/2 mL market achieved annual sales of approximately USD 437.9 million.
Published on Jun 23, 2021 12:30 pm IST

Lupin gets warning letter from US health regulator for Somerset facility

When USFDA finds that a manufacturer has significantly violated FDA regulations, it notifies the manufacturer. This notification is often in the form of a warning letter.
Published on Jun 14, 2021 10:45 am IST

Discard 60 million Covid vaccine doses made at Baltimore plant: US FDA to J&J

The FDA said its decision allows the J&J doses to be used in the United States or exported.
Published on Jun 11, 2021 11:12 pm IST

Covaxin’s US approval delayed, Bharat Biotech’s partner to seek full approval

A medic administers Covaxin, developed by Bharat Biotech (PTI).
Updated on Jun 11, 2021 11:46 am IST

US resumes J&J Covid vaccinations despite clotting fears

The ACIP voted 10 to 4 to back the Johnson & Johnson vaccine, opening the way for the US CSC and Prevention and the FDA to lift a pause on the shot that was put in place after reports of rare, serious blood clots among recipients.
Published on Apr 24, 2021 05:44 am IST

FDA advisory panel to review J&J Covid-19 vaccine with thumbs up expected

In a 44,000-person trial, the vaccine overall was 66% effective at preventing moderate-to-severe cases of Covid-19 compared with a placebo.
Published on Feb 26, 2021 11:09 pm IST

Covid-19 vaccine update: Pfizer applies for EUA in Japan, FDA to approve Moderna candidate

Pfizer has developed its vaccine candidate with BioNTech SE (FILE PHOTO)
Updated on Dec 18, 2020 10:05 am IST

HCP Wellness expanding its manufacturing of oral care and skin care cosmetics plants to Ahmedabad to meet market demand

Ahmedabad-based HCP Wellness has established a robust skin care cosmetics and oral care manufacturing unit.
Updated on Dec 17, 2020 04:54 pm IST

At review meet, PM asked about emergency authorisation process of vaccines: Officials

Prime Minister Narendra Modi addresses the eighth convocation of Pandit Deendayal Petroleum University, Gandhinagar, via video conferencing, in New Delhi on November 21.
Updated on Nov 22, 2020 02:45 pm IST

South Korea’s Celltrion says received US authorisation for its Covid-19 test kit

The logo of Celltrion is seen at the company's headquarters in Incheon, South Korea (REUTERS/Kim Hong-Ji/Files)
Updated on Oct 26, 2020 02:10 pm IST

Import licenses for Covid-19 kits of 3 firms cancelled, 16 suspended by DCGI

They were directed to submit their reply by July 20, failing which it would be presumed they have nothing to say in the matter and action deemed fit will be initiated under provisions of the Drugs and Cosmetics Act.
Updated on Jul 25, 2020 09:29 pm IST

Covid-19 update: Natco Pharma donates chloroquine tablets for global trials

The company has donated the tablets through Rising Pharmaceuticals.  Washington University School of Medicine in St Louis is the clinical coordinating center for this trial, Natco Pharma said in a BSE filing.
Published on May 19, 2020 02:27 pm IST

8 Indian-Americans held for supplying opioid pills in US

Since January 2018, US law enforcement authorities had been investigating the large-scale importation of misbranded controlled substances into the US from India.
Updated on Sept 14, 2019 10:17 am IST