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US approves new antibody treatment -- for arthritic cats

These lab-grown proteins have grabbed headlines during the pandemic for preventing high-risk people with Covid from getting severely ill.

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

J&J vaccine gets additional warning on bleeding aide effect

J&J vaccines has been accused of causing serious blood clots and compelling a rare bleeding disorder. 

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.”(MINT_PRINT)
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.”(MINT_PRINT)
Published on Jan 13, 2022 10:56 AM IST

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

The disease affects about 40,000 people in the United States, with about 4,000 new cases each year, according to the company.

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. (Reuters)
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. (Reuters)
Published on Oct 08, 2021 10:42 PM IST

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

This follows award of full approval to Pfizer's vaccine by the FDA on Monday.

Moderna Covid-19 vaccine (AP)
Moderna Covid-19 vaccine (AP)
Published on Aug 25, 2021 08:53 PM IST

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

"Will look forward to full approval for Moderna and Johnson & Johnson's vaccines as well," the White House said.

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

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

Here are today’s top news, analysis, and opinion at 9pm. Know all about the latest news and other news updates from Hindustan Times.

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

Glenmark Pharma gets USFDA nod for inhalation product

The approved product is a generic version of Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc.

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.(Reuters file photo. Representative image)
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.(Reuters file photo. Representative image)
Published on Jun 23, 2021 12:30 PM IST

Lupin gets warning letter from US health regulator for Somerset facility

Lupin is committed to addressing the concerns raised by the USFDA and will work with the FDA and the New Jersey district to resolve these issues at the earliest, the filing said.

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.(REUTERS)
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.(REUTERS)
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 agency said it was not yet ready to authorize Emergent's plant for manufacturing the J&J vaccine.

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

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

Ocugen, which has partnered with Bharat Biotech to produce Covaxin for US market, said it will now seek full approval for the shot.

A medic administers Covaxin, developed by Bharat Biotech (PTI).
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 agencies could decide to resume use of the vaccine as soon as Friday evening. The FDA will include a warning statement with the shot about the risk of clots, which have primarily been seen in young women.

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.(REUTERS)
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.(REUTERS)
Published on Apr 24, 2021 05:44 AM IST

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

After it receives the recommendation, the FDA is likely to authorize the vaccine for emergency use within a day or so, making it the third available in the United States, and the only one that requires just one shot.

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.(AP)
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.(AP)
Published on Feb 26, 2021 11:09 PM IST
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