Page 4 - Fda

Maharashtra FDA cancels manufacturing licence of J&J baby powder

The state government body also said that the use of the product may affect the health of the skin of newborn babies

Top headlines: Vehicle sales up 8% in Aug; Fitch affirms rating for 4 NBFCs

Two-wheeler sales were up 8.5 per cent and three-wheeler by 8.3 per cent in August. Passenger and commercial vehicle sales increased 6.5 per cent and 24 per cent

FDA panel backs much-debated experimental ALS drug in rare second review

A panel of federal health advisers have voted to recommend approval for an experimental drug to treat Lou Gehrig's disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The Food and Drug Administration advisers voted 7-2 that data from Amylyx Pharma warranted approval, despite hours of debate about the strength and reliability of the company's lone study. The FDA is not required to follow the group's advice, but its positive recommendation suggests an approval is likely later this month. The FDA has approved only two therapies for the disease, amyotrophic lateral sclerosis, or ALS, which destroys nerve cells needed for basic functions like walking, talking and swallowing. ALS patients and their families have rallied behind Amylyx's drug, launching an aggressive lobbying campaign and enlisting members of Congress to push the FDA to grant approval. Despite a negative review published by FDA's internal ...

USFDA rush after 2-year lull: 20-30% new products may be open to inspection

The last two years saw limited physical inspections due to travel restrictions during the pandemic

FDA authorizes first-ever breathing test for detecting Covid-19 infection

The agency said that in a study of 2,409 people, which included both people with and without symptoms, the test had a 99.3 per cent specificity rate

Moderna seeks FDA authorization for second Covid booster for all adults

Moderna Inc on late Thursday sought emergency use authorization with US health regulators for a second Covid booster shot, as a surge in cases in some parts of the world fuels fears of another wave

Moderna seeks FDA authorization for 4th dose of Covid vaccine shot

Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults. The request is broader than rival pharmaceutical company Pfizer's request earlier this week for the regulator to approve a booster shot for all seniors. In a press release, the company said its request for approval for all adults was made to provide flexibility to the Centers for Disease Control and Prevention and medical providers to determine the appropriate use of a second booster dose of the mRNA vaccine, including for those at higher risk of COVID-19 due to age or comorbidities." U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines' protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to urgently approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either fo

US man who got first pig heart transplant dies after 2 months

David Bennett, 57, died Tuesday at the University of Maryland Medical Center

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