Page 2 - Fda

How safe is the pill? Substandard drugs on a decline amid crackdown

The first of a two-part series focuses on how quality audits and regulatory actions on pharma units nationwide are showing results

Elon Musk's Neuralink gains FDA breakthrough tag for vision implant

Neuralink's vision-restoring device, named Blindsight, is designed to allow even individuals who have lost both eyes and their optic nerves to regain sight

US FDA expands J&J's psoriasis drug Tremfya for inflammatory bowel disease

Drugmakers such as AbbVie, Eli Lilly and J&J are hustling for a share in an already-crowded, multi-billion market for treatments for inflammatory bowel diseases

USFDA still struggling to conduct pending drug inspections after Covid

Federal regulators responsible for the safety of the US drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the US and across the world, The Associated Press has found. An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections since before the pandemic. The firms that are overdue for safety and quality inspections represent about 42 per cent of the 4,700 plants that are currently registered to produce drugs for the US and previously underwent FDA review before May 2019, the AP found. Most of the overdue plants are in the US, but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost US prescriptions. Generic drugmakers are under intense pressure to cut their costs and some will do that by cutting quality, sa

US FDA declines to approve Regeneron's therapy for common blood cancer

FDA, in a so-called 'complete response letter', said that the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party manufacturer

US FDA approves first nasal spray from ARS Pharmaceuticals' for allergies

Neffy's approval is based on 4 studies in 175 healthy adults without anaphylaxis that measured epinephrine concentrations in blood following administration of neffy

USFDA approves second Alzheimer's drug that can modestly slow disease

U.S. officials have approved another Alzheimer's drug that can modestly slow the disease, providing a new option for patients in the early stages of the incurable, memory-destroying ailment. The Food and Drug Administration approved Eli Lilly's Kisunla on Tuesday for mild or early cases of dementia caused by Alzheimer's. It's only the second drug that's been convincingly shown to delay cognitive decline in patients, following last year's approval of a similar drug from Japanese drugmaker Eisai. The delay seen with both drugs amounts to a matter of months about seven months, in the case of Lilly's drug. Patients and their families will have to weigh that benefit against the downsides, including regular IV infusions and potentially dangerous side effects like brain swelling. Physicians who treat Alzheimer's say the approval is an important step after decades of failed experimental treatments. I'm thrilled to have different options to help my patients, said Dr. Suzanne Schindler, a .

US FDA grants accelerated approval to Genfit, Ipsen's liver disease drug

Ipsen added that standard approval for Iqirvo may be contingent on confirmatory trials

FDA warns against infant formula by Texas firm due to contamination

US health officials warned parents to avoid powdered infant formula sold by a Texas dairy producer, because a dangerous bacteria was found in one of the company's products. The Food and Drug Administration issued the alert Friday on Crecelac Infant Powdered Goat Milk Infant Formula, after a sample collected from a Texas store tested positive for cronobacter, which can cause deadly infections in babies. The same bacteria sparked recalls and shortages of infant formula in 2022 after it was detected at a major US formula factory. The Crecelac formula was imported and distributed by Dairy Manufacturers Inc., of Prosper, Texas, according to the FDA. Press releases from the FDA and the company did not specify where the product was produced or how widely it was distributed in the US Messages left for the company on Friday were not immediately returned. Last week, the company voluntarily recalled the Crecelac formula and another brand, Farmalac, because they had not received approval by the

US drug regulator delaying decision on RSV vaccine approval, says Moderna

The FDA hasn't informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent approval, Moderna said Friday in a statement

Two fall sick after eating at Noida's McDonald's, Theobroma; probe on

FDA immediately took action and visited McDonald's at Noida Sector 18 to collect the samples

In 6 months, US rejected nearly one-third of MDH's spice-related shipments

Refusal rate over salmonella contamination doubles. When ingested, salmonella can lead to a severe stomach infection affecting the intestinal tract if food is not adequately cooked

FDA revokes licence of McDonald's store after action over cheese

The Maharashtra Food and Drug Administration (FDA) has revoked the licence of a McDonald's outlet in the state's Ahmednagar district after taking action against it over cheese, an official said on Saturday. The eatery belonging to the fast food giant had faced FDA scrutiny for allegedly using a cheese-like product in their dishes without indicating that it was actually a cheese substitute, thereby misleading customers, he said. Following an inspection and subsequent objections, the licence of the outlet was suspended, but it was revoked recently after the chain filed a compliance report confirming that they had removed the word cheese' from product names. In October 2023, we visited the outlet in Kedgaon and discovered that the names of food items displayed at the outlet included American Cheese Burger, American Cheese Nuggets, Cheese Burger, Italian Cheesy Lava Burger, and Blueberry Cheese Cake. All these names are their brand names for their products," said Rajendra Bade, a food .

McDonald's removes 'cheese' from its outlet menus in Maharashtra

Move comes after Maharashtra FDA accused chain of using cheese substitutes in burgers and nuggets

Maharashtra FDA cracks down on McDonald's for using substitutes for cheese

McDonald's has denied accusations of misleading consumers by using substitutes in place of real cheese in burgers and nuggets

US approves 1st vaccine against chikungunya virus: All you need to know

Symptoms of chikungunya can sometimes last for months or even years, but the virus is rarely fatal

Aurobindo Pharma arm receives FDA nod for Testosterone Cypionate injection

According to research firm IQVIA, the approved product has an estimated market size of $226.8 million for the twelve months ending August 2023

Lupin receives US regulator's approval for Cyanocobalamin nasal spray

The nasal spray manufactured by Lupin is a generic version of Nascobal nasal spray

Pharma major Lupin gets establishment inspection report from USFDA

Lupin Limited received an inspection classification of "No Action Indicated" (NAI) after the inspection, which was conducted between March 6 to March 10

Covid pill Paxlovid gets full FDA approval after a year of emergency use

Pfizer received full approval on Thursday for its COVID-19 pill Paxlovid that's been the go-to treatment against the coronavirus. More than 11 million prescriptions for Paxlovid have been dispensed since the Food and Drug Administration allowed emergency use in late 2021. The emergency status was based on early studies and was intended to be temporary pending follow-up research. The FDA granted full approval for adults with COVID-19 who face high risks of severe disease, which can lead to hospitalization or death. That group typically includes older adults and those with common medical conditions like diabetes, asthma and obesity. The decision allows Pfizer's drug to remain on the market indefinitely and to be marketed similarly to other drugs. The pill is still available for children ages 12 to 17 under a separate emergency authorisation. The US government has stockpiled millions of doses of Paxlovid and patients will continue to receive it at no charge, the FDA said in a stateme