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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 11 days ago

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 200 days ago

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

The overdose-reversal drug Narcan is displayed.

Published 1202 days ago

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 1255 days ago

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 1642 days ago

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 1643 days ago

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

Published 1739 days ago

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

Moderna Covid-19 vaccine (AP)

Published 1783 days ago

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

Pfizer Covid-19 vaccine (Reuters/File Photo)

Published 1785 days ago

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

Pfizer's Covid-19 vaccine (Reuters)

Published 1785 days ago

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 1847 days ago

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 1856 days ago

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 1858 days ago

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

A medic administers Covaxin, developed by Bharat Biotech (PTI).

Updated 1859 days ago

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 1907 days ago

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 1963 days ago

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