Page 3 - Fda

Covid: US FDA declines emergency use nod for Covaxin for 2-18 age group

Bharat Biotech's US partner Ocugen said it intends to continue working with the US FDA to evaluate the process for getting an EUA for pediatric use of Covaxin

Lupin gets FDA nod to market Efinaconazole topical solution in US

Drug major Lupin on Thursday said it has received approval from the US health regulator to market Efinaconazole topical solution, used to treat fungal toenail infections, in the American market

Glenmark Pharma gets tentative FDA nod for generic Regadenoson injection

Glenmark Pharmaceuticals on Monday said its US arm has received tentative approval from the country's health regulator for its generic Regadenoson injection. Regadenoson injection is given during the preparation for a radiologic examination of blood flow through the heart to test for coronary artery disease. The tentative approval granted by the United States Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe, the company said in a statement. It is the generic version of Lexiscan injection, 0.4 mg/5 mL (0.08 mg/mL), of Astellas US Inc, it added. Citing IQVIATM sales data for the 12 month period ending November 2021, the company said the Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) market achieved annual sales of approximately USD 659.9 million. The company said its current portfolio consists of 172 products authorized for distribution in the US marketplace and 47 .

Covid: FDA expands Pfizer boosters for more teens as omicron surges

The US is expanding Covid-19 boosters as it confronts the omicron surge, with the Food and Drug Administration allowing extra Pfizer shots for children as young as 12.

Cipla stock rises on strong launch pipeline, FDA approval for injection

Margin gains and steady growth in the Indian market to support the stock, say analysts.

FDA authorises Pfizer, Moderna Covid-19 vaccine boosters for US adults

The regulator's decision paves the way for millions of Americans to get additional protection

More US states offering boosters amid fears of Covid resurgence in winters

California made the first move to expand access. Within days, officials in Colorado, New Mexico, Arkansas, West Virginia and New York City endorsed boosters for all adults

Merck asks US FDA to authorise promising anti-Covid pill

If cleared by the Food and Drug Administration a decision that could come in a matter of weeks it would be the first pill shown to treat Covid

Pfizer seeking FDA approval for coronavirus vaccine booster dose

Pfizer is seeking US approval of a booster dose of its two-shot COVID-19 vaccine. The drugmaker said Wednesday that it has started the application process for a third dose of its vaccine for people ages 16 and older. The company said it will complete the application with the Food and Drug Administration by the end of this week. The company's move follows an announcement by U.S. health officials last week of plans to give COVID-19 booster shots to all Americans to shore up their protection amid the surging delta variant of the virus. Officials said it is very clear that the vaccines' protection against COVID-19 infections wanes over time. Pfizer's vaccine received full FDA approval earlier this week; it had been used since last December under an emergency use authorization. The three vaccines used in the U.S. made by Pfizer, Moderna and Johnson & Johnson are still preventing hospitalizations and deaths from COVID-19. But the vaccines don't appear quite as strong against the highly .

Eli Lilly to seek FDA approval for potential Alzheimer's drug

Shares of Eli Lilly and Co. jumped more than 8%, or $18.59, to $235.69 at the opening bell Thursday.

Eli Lilly memo says firm did not make false statements to FDA

(Reuters) - A week before Eli Lilly disclosed to regulators that the U.S. Justice Department was investigating its New Jersey factory, the drugmaker told employees that its own inquiry, led by an outside law firm, found no evidence of wrongdoing there, according to a company memo reviewed by Reuters.

US FDA advisory panel meets on Pfizer's Covid-19 vaccine emergency use

The committee of outside experts is expected to vote on whether the vaccine, developed along with German partner BioNTech, has shown effectiveness in preventing Covid-19

Pick-up in biosimilar launches driving Biocon's prospects; stock rises 7.8%

As US launch of Insulin addresses a large market, improved visibility for more launches will keep sentiment elevated

Lockdown 3.0: Pharma hubs take extra precaution to tame Covid-19 outbreak

Recently, while 26 workers at Cadila Pharmaceuticals facility in Ahmedabad tested positive for Covid-19, one person at Sun Pharma's Halol plant tested positive.

Coronavirus: FDA cracks down on sale, manufacture of substandard sanitisers

The FDA has seized such products worth lakhs during raids on local manufacturing units in western suburbs in the last few days, he said

Get FDA license or face shutdown: Goa govt warns high-end restaurants

The warning comes amid concerns over rising food adulteration and use of carcinogenic chemicals in fruits and vegetables by traders

Godfrey Philips moves Bombay HC over e-cigarette seizure by Maharashtra FDA

The bench directed the authorities to file their affidavits, and posted the petition for further hearing on July 30

Gujarat FDA cancels licenses of 15 blood banks for violating standard norms

The Gujarat FDA has cancelled licenses of 15 blood banks in the state for not following standard practices to store and distribute blood. "The state regulator has asked these blood banks to pull down the shutter as they are repeated defaulters." said its chief Dr H G Koshia .The Gujarat FDA feels that these blood banks are substandard due to the unavailability of kits to test antibodies and other equipment related issues. There were 156 blood banks in the state. With these cancellations, 141 have licenses to operate. Cancellation of license has taken place across a number of cities like Ahmadabad, Rajkot among others. As per the rules, a 24/7 blood bank is required to have at least three Blood Transfusion Officers (BTOs) working in shifts. It is also mandatory that while collecting and transfusing blood, its components such as plasma, white blood cells are tested in the presence of a BTO to avoid fatal mistakes.Gujarat is not the only state to tighten the grip on blood banks. ...

US FDA to continue working with Indian partners in training food suppliers

FSMA directs FDA to work with food producers to systematically prevent safety problems