Page 9 - Us Fda
FDA panel takes up tough questions on J&J Covid-19 boosters
U.S. health advisers on Friday tackled who should get boosters of Johnson & Johnson's single-shot COVID-19 vaccine and when - and whether using a competing brand for the second dose might provide better protection. The push for boosters kicked off last month after the Food and Drug Administration authorized third doses of the Pfizer vaccine for seniors and younger adults with health problems, jobs or living conditions that place them at higher risk from the coronavirus. On Thursday, an FDA advisory panel unanimously recommended a half-dose booster of the similar Moderna vaccine for the same groups. Friday, the same panel discussed a booster of J&J's vaccine but the decision is more complex. Moderna and Pfizer asked the FDA to OK boosters at least six months after immunization, but J&J proposed a sliding schedule with an extra dose as early as two months later. Adding another twist, the experts also will discuss preliminary data from a government mix-and-match study that ...
 "FDA panel takes up tough questions on J&J Covid-19 boosters")
US FDA to evaluate J&J, Moderna Covid booster jabs this week
The US Food and Drug Administration is expected to evaluate the efficacy of Moderna and Johnson & Johnson's third dose of Covid vaccines this week.
 "US FDA to evaluate J&J, Moderna Covid booster jabs this week")
A step from Covid-19 pills as Merck & Co seeks FDA approval
An application was submitted with the Food and Drug Administration for molnupiravir to treat mild-to-moderate Covid-19 in adults at risk of developing a severe illness that may require hospitalization
 "A step from Covid-19 pills as Merck & Co seeks FDA approval")
J&J seeks FDA's approval for Covid-19 vaccine booster shot in adults
If authorized, J&J's booster could give millions more Americans additional protection against the coronavirus
 "J&J seeks FDA's approval for Covid-19 vaccine booster shot in adults")
FDA approves older, Covid at-risk people for Pfizer booster shot in US
Booster doses can be given any time at least six months after a person received their second shot, says the agency.
 "FDA approves older, Covid at-risk people for Pfizer booster shot in US")
Health officials back US FDA panel's decision on Covid booster shot
US health officials have voiced their support for the recommendation from the Food and Drug Administration (FDA) advisory panel that Covid-19 booster shots be limited to those 65 years and older
 "Health officials back US FDA panel's decision on Covid booster shot")
US FDA panel backs booster shot for elderly, high risk groups
A US FDA advisory panel has endorsed a booster shot of Pfizer-BioNTech Covid-19 vaccine six months after full inoculation in people above 65 years and for individuals at high risk for severe disease
 "US FDA panel backs booster shot for elderly, high risk groups")
FDA panel is first key test for Biden administration's Covid booster plan
A government advisory panel met to decide whether to endorse extra doses of the Pfizer vaccine
 "FDA panel is first key test for Biden administration's Covid booster plan")
Covid LIVE: ZyCoV-D is likely to be launched in early October, says report
The national recovery rate was recorded at 97.49 per cent, the health ministry said.
 "Covid LIVE: ZyCoV-D is likely to be launched in early October, says report")
Aurobindo Pharma gets USFDA nod for cancer treatment injection
Drug firm Aurobindo Pharma on Friday said its arm Eugia Pharma Specialities has received approval from the US health regulator for Cyclophosphamide injection, used in the treatment of several types of cancer. The company's subsidiary "Eugia Pharma Specialities Ltd has received a 505(b)(2) NDA approval from the US Food & Drug Administration (USFDA) for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vial," Aurobindo Pharma said in a regulatory filing. The product will be available in ready-to-use injection preparation, it added. "The product shall be launched in the US market in the near term and will be manufactured in Eugia's manufacturing facility in India," Aurobindo Pharma said. According to IQVIA, the approved product has an addressable market size of USD 170 million for the twelve months ending June 2021, it added. Cyclophosphamide Injection is indicated for malignant lymphomas, multiple myeloma, leukemia, mycosis fungoides, neuroblastoma, adenocarcinoma of the ...
 "Aurobindo Pharma gets USFDA nod for cancer treatment injection")
Fauci expects uptick in vaccine administration after FDA OKs Pfizer shot
Dr. Anthony Fauci says he's hoping for an uptick in the administration of Covid-19 vaccinations following US government approval of the Pfizer vaccine
 "Fauci expects uptick in vaccine administration after FDA OKs Pfizer shot")
Covid-19 pandemic: US okays third jab for those with low immunity
The amended emergency use authorization paves the way for people who have had an organ transplant, or those with a similar level of weakened immune system, to get an extra dose
 "Covid-19 pandemic: US okays third jab for those with low immunity")
US FDA okays Covid booster dose for those with weak immune system
The US FDA authorised both the Pfizer-BioNTech and Moderna's Covid-19 vaccine to administer an additional dose in people with weaker immune systems, which includes organ transplant recipients
 "US FDA okays Covid booster dose for those with weak immune system")
FDA adds warning of rare neurological reaction to J&J Covid-19 vaccine
US regulators on Monday added a new warning to Johnson & Johnson's COVID-19 vaccine about links to a rare and potentially dangerous neurological reaction, but said it's not entirely clear the shot caused the problem. The Food and Drug Administration announced the new warning, flagging reports of Guillain-Barre syndrome, an immune system disorder that can causes muscle weakness and occasionally paralysis. Health officials described the side effect as a small possible risk" for those getting the shot. The action comes after the FDA and the Centers for Disease Control and Prevention reviewed reports of about 100 people developing the syndrome after receiving the one-dose vaccine. Almost all of them required hospitalization and one person died, the FDA said. Guillain-Barre syndrome occurs when the body's immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes paralysis that typically is temporary. An estimated 3,000 to 6,000 people develop the ..
Covid-19 pandemic: Pfizer seeks US regulator's nod for booster shot
FDA and EU regulator say no need for extra dosage at this time
 "Covid-19 pandemic: Pfizer seeks US regulator's nod for booster shot")
A bottleneck in the vaccine chain
Prosenjit Datta points to a possible crisis as the government moves to improve supplies of Covid vaccines: inadequate testing facilities to handle those volumes
Glenmark Pharma gets US health regulator nod for inhalation product
Glenmark Pharma said it received approval from the US health regulator for Arformoterol Tartrate Inhalation Solution, used to treat conditions like chronic bronchitis and emphysema, in the US market
 "Glenmark Pharma gets US health regulator nod for inhalation product")
FDA denies Bharat Bio's US partner emergency approval for Covaxin vaccine
US FDA has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application route with additional data, nixinghopes of Emergency Use Authorisation
 "FDA denies Bharat Bio's US partner emergency approval for Covaxin vaccine")
US FDA approves Biogen's drug aducanumab to treat Alzheimer's disease
By Deena BeasleyBiogen's drug had been hailed by patient advocates and some neurologists eager to have an effective option for patients with the lethal disease.
 "US FDA approves Biogen's drug aducanumab to treat Alzheimer's disease")
Drug firm Lupin gets US FDA approval to market generic HIV drug
The product will be manufactured at the company's facility in Nagpur
 "Drug firm Lupin gets US FDA approval to market generic HIV drug")