Page 5 - Us Fda

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.

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 ...

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

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

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

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

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

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

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.

Drug firm Lupin gets US FDA approval to market generic HIV drug

The product will be manufactured at the company's facility in Nagpur

Tracing Covid-19's origin: Five ways US is pressing China to solve mystery

In the past few weeks, the United States has pressed China on tracing the origin of the virus.

FDA authorises third antibody drug for mild-to-moderate Covid-19 cases

U.S. health officials have granted emergency authorisation to a third antibody drug to help reduce hospitalisations and deaths due to Covid-19

Bharat Biotech's US partner Ocugen submits 'Master File' to FDA on Covaxin

Ocugen, Bharat Biotech's American partner for Covaxin, has submitted a 'Master File' to the US Food and Drug Administration prior to seeking an emergency use authorisation in that country

Bharat Biotech in talks for clinical trials of Covaxin in US: Report

Bharat Biotech submitted 90% of documents to WHO for obtaining emergency use listing for Covaxin vaccine, say sources

US FDA to authorise Pfizer jabs for 12 to 15-year-old by next week

Vaccinating adolescents may also be key to boost immunity levels in the general population

US says it will share 60 million AstraZeneca vaccine doses with world

The inoculation is used around the world but has not yet been authorised by the US Food and Drug Administration.

Pfizer asks US FDA to clear its coronavirus vaccine for use in kids

Pfizer and BioNTech have asked the US Food and Drug Administration (FDA) to expand the Emergency Use Authorization (EUA) for its Covid-19 vaccine to include children ages 12 to 15.

US FDA nod to Teva for key specialty product to weigh on Sun Pharma

Strong US portfolio, margin gains and India business growth to support stock