Page 8 - Us 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 launches generic medication, to be manufactured in Nagpur, in US

Drug maker Lupin on Tuesday said it has launched Sevelamer Hydrochloride tablets (800 mg), used to treat hyperphosphatemia in patients with chronic kidney disease, in the US market

Glenmark gets FDA approval for nasal spray for seasonal allergic rhinitis

Glenmark Pharmaceuticals Limited said its subsidiary Glenmark Specialty S.A. has received US FDA approval for nasal spray fixed dose prescription drug for seasonal allergic rhinitis Ryaltris.

US govt programme to cover Biogen Alzheimer's drug only for trial patients

The FDA approved the drug in June despite its committee of outside experts voting in November 2020 that the drug should not be approved.

Swiss drugmaker Idorsia's insomnia medicine gets US FDA's approval

The drug, to be available under the brand name Quviviq, was approved in doses of 25 mg and 50 mg based on data from two late-stage trials

Cadila Healthcare's US arm receives FDA nod to market Pimavanserin capsule

Cadila Healthcare on Friday said its US arm Zydus Pharmaceuticals (USA) Inc has received tentative approval from the US health regulator to market generic Pimavanserin capsules, indicated for treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The approval by the US Food & Drug Administration for the generic Pimavanserin capsules is for the strength of 34 mg, Cadila Healthcare said in a regulatory filing. "The drug will be manufactured at the group's formulation manufacturing facility at SEZ Ahmedabad," it said. The group now has 325 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04, it added.

Rapid antigen tests less sensitive for detecting Omicron infections: US FDA

The Food and Drug Administration in the US has said that rapid antigen tests are less sensitive for detecting Omicron variant infections

US FDA authorizes Pfizer's Covid-19 antiviral pill for people aged 12

The US Food and Drug Administration (FDA) on Wednesday (local time) authorized Pfizer's Paxlovid COVID-19 pill for high-risk people aged 12 and over to treat coronavirus disease (COVID-19)."The US Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death," US Food and Drug said in a statement."Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and

US regulators lift in-person restrictions on abortion pills

The Food and Drug Administration is loosening some restrictions on where women can obtain abortion pills, including a long-standing requirement that the medication be picked up in person

Market wrap: Benchmarks end lower for a second day; Sensex slips 166 pts

NBFCs to come under the ambit of PCA framework from Oct 2022; Anand Rathi Wealth debuts at 9% premium; WPI-based inflation hits 12-year high of 14.2% in Nov

Lupin surges 10% on good volumes after getting EIR from USFDA for Goa plant

Despite of today's gain, the stock has underperformed the market by falling 18 per cent in past six months, as compared to 10.5 per cent rally in the S&P BSE Sensex

US FDA okays AstraZeneca's Covid antibody cocktail for immunocompromised

The US Food and Drug Administration (FDA) has granted emergency use authorisation to AstraZeneca's monoclonal antibody treatment for Covid-19 among people with weakened immune systems.

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

FDA plans to authorise Pfizer boosters for adults this week: Report

The Food and Drug Administration is aiming to authorise booster doses of Pfizer-BioNTech's coronavirus vaccine for all adults as early as Thursday

Joe Biden picks senior Google Health advisor Robert Califf as FDA chief

US President Joe Biden has picked senior Google Health advisor Dr Robert Califf as next chief of the Food and Drug Administration

Travellers fully vaccinated with Covaxin can enter US from Nov 8

The last-minute addition comes less than one week before the US launches its new travel system, granting entry to travellers who have received a vaccine that has been approved by the FDA or WHO.

Covid-19 vaccine for younger kids showed strong results, says Moderna

Health officials are aiming to get immunizations to younger children before the holiday season, when travel and indoor activity can bring an increased risk of infection

US FDA says Pfizer Covid-19 vaccine looks effective for young kids

Federal health regulators said late Friday that kid-size doses of Pfizer's COVID-19 vaccine appear highly effective at preventing symptomatic infections in elementary school children

Pfizer says its Covid vaccine is 91% effective in kids of ages 5 to 11

The efficacy result is based on a trial of about 2,250 children, according to the briefing documents

US FDA clears Moderna, J&J booster shots; backs Covid-19 vaccine mixing

Pfizer and BioNTech said a booster shot of their Covid-19 vaccine restored full protection in a large study, results that are likely to bolster the argument for giving a third dose more widely