Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Icatibant injection indicated for the treatment of acute attacks of hereditary angioedema in adults. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing. This is the first peptide product approval from the USFDA received by the company, Alembic Pharma said. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), of Takeda Pharmaceuticals USA, Inc, it added. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Hereditary angioedema is a disorder characterised by recurrent episodes of severe swelling (angioedema)
Putin is expected to visit Vietnam on Wednesday and Thursday, after repeated invitations from Vietnamese leaders
China has 27 nuclear reactors under construction with average construction timelines of about seven years, far faster than other countries
Two people were killed aboard a vintage plane that crashed and burst into flames near a Southern California airfield during a weekend Father's Day event hosted by an air museum, authorities said Sunday. The Federal Aviation Administration said the twin-engine Lockheed 12A crashed shortly after 12:30 pm Saturday, just west of Chino Airport in San Bernardino County. Firefighters doused the flames within 10 minutes before finding the two people dead inside, said Chino Valley Fire District Battalion Chief Bryan Turner. The victims' names were not released as of Sunday afternoon. Turner described the aircraft as older and historical. The plane belonged to the Yanks Air Museum, the Southern California News Group reported. At this time we are working with local authorities and the FAA. Yanks Air Museum will be closed until further notice as our family deals with this tragedy, and we appreciate your patience and respect for our privacy as we navigate through this difficult time, the air ..
A wildfire that forced the evacuation of at least 1,200 people in southern California has burned over 16 square miles, officials said Sunday. The blaze, named the Post Fire, started Saturday and was burning near the Interstate 5 freeway in Gorman, about 62 miles (100 kilometres) northwest of Los Angeles, according to the California Department of Forestry and Fire Protection. California State Park Services evacuated 1,200 people from the Hungry Valley recreation area in Gorman and both Hungry Valley and the Pyramid Lake reservoir were closed as a result of the fire threat, the Los Angeles County Fire Department said. The flames broke out at around 1:45 pm, authorities said. The cause isn't known. No homes were threatened by the fire but two commercial buildings have been damaged, the Los Angeles County Fire Department said Sunday. The fire was moving southeast toward Pyramid Lake and crews were constructing perimeter fire lines while aircraft worked against limited visibility to st
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Canada and the European Central Bank have been the first ones to introduce rate cuts, however, they have expressed their concerns about inflation
A powerful bipartisan US congressional delegation, led by House Foreign Affairs Committee Chairman Michael McCaulis, is visiting India to strengthen bilateral ties and to meet the Tibetan spiritual leader the Dalai Lama. The delegation includes former US House Speaker Nancy Pelosi, House Foreign Affairs Committee Ranking Member Gregory W. Meeks, House Rules Committee Ranking Member Jim McGovern, House Foreign Affairs Subcommittee on the Indo-Pacific Ranking Member Ami Bera, and Congressman Mariannette Miller-Meeks and Nicole Malliotakis. In India, the delegation will meet the 14th Dalai Lama, Indian government officials, and representatives of US businesses in the country. India is the world's largest democracy and an important strategic partner of the United States, said McCaul. I look forward to meeting with government officials and the American business community to learn how we can continue to strengthen our relationship with India, he said. I am also honoured to have the ...
The United States military unleashed a wave of attacks targeting radar sites operated by Yemen's Houthi rebels over their assaults on shipping in the crucial Red Sea corridor, authorities said Saturday, after one merchant sailor went missing following an earlier Houthi strike on a ship. The attacks come as the US Navy faces the most intense combat its seen since World War II in trying to counter the Houthi campaign attacks the rebels say are meant to halt the Israel-Hamas war in the Gaza Strip. However, the Iranian-backed rebel assaults often see the Houthis target ships and sailors who have nothing to do with the war while traffic remains halved through a corridor vital for cargo and energy shipments between Asia, Europe and the Mideast. US strikes destroyed seven radars within Houthi-controlled territory, the military's Central Command said. It did not elaborate on how the sites were destroyed and did not immediately respond to questions from The Associated Press. These radars ..
Prime Minister Narendra Modi and his Italian counterpart Giorgia Meloni have reviewed the progress of the bilateral strategic partnership and agreed to strengthen cooperation in global fora and multilateral initiatives, including the India-Middle East-Europe Economic Corridor. The two leaders met on Friday towards the end of Prime Minister Modi's day-long visit to Apulia, southern Italy, during which he thanked the Italian Prime Minister for the invitation to attend the G7 Summit. A Ministry of External Affairs (MEA) readout of the meeting said the leaders committed to fulfil their shared vision for a free and open Indo-Pacific and also discussed the India-Middle East-Europe Economic Corridor (IMEC). Both leaders look forward to joint activities to be implemented under the Indo-Pacific Ocean Initiative framework to fulfil their shared vision for a free and open Indo-Pacific," the Ministry of External Affairs said, amidst China's aggressive actions in the region. They also discussed
A bipartisan group of 43 lawmakers has urged the Biden administration to take urgent action to protect more than 250,000 Documented Dreamers, a significantly large number of whom are Indians, who will be forced to self-deport after ageing out of the temporary legal status derived through their parents' visas. Documented Dreamers are foreign nationals who entered the United States as dependents under their parents' temporary, nonimmigrant visa status, usually a work visa. Despite growing up in the US with legal status, children of long-term visa holders age out of their dependent status when they turn 21 and are often left with no choice but to leave the United States if they cannot transition to a new status, the lawmakers said in a letter to Homeland Security Secretary Alejandro Mayorkas and the US Citizenship and Immigration Services (USCIS) Director Ur M Jaddou. This is because, in part, their families' adjustment of status applications face extensive backlogs, preventing them fr
In 2016 and 2021, the Food and Drug Administration (FDA) made efforts to make it easier to prescribe and distribute the medication
President Joe Biden said on Thursday that he will not use his presidential powers to lessen the eventual sentence that his son Hunter will receive for his federal felony conviction on gun crimes. Biden, following the conclusion of a news conference held at the Group of Seven summit of the world's wealthiest democracies, responded he would not when asked whether he plans to commute the sentence for his son. Hunter Biden's sentencing date has not been set, and the three counts carry up to 25 years in prison. Whether Hunter Biden actually serves any time behind bars will be up to US District Judge Maryellen Noreika, who was nominated to the bench by former Republican President Donald Trump. Biden's remarks came one day after the White House declined to rule out a potential commutation for Hunter Biden. Both the president and the White House have said for months that Biden would not pardon his son. I'm extremely proud of my son Hunter. He has overcome an addiction. He is one of the ..
Zelenskyy made the remarks at a joint news conference with US President Joe Biden, which was held on the sidelines of the G7 Summit in Italy on Thursday
The funding is part of Project NextGen, a $5 billion initiative led by the Biomedical Advanced Research and Development Authority (BARDA)
President Joe Biden, 81, and former President Donald Trump, who turns 78 on Friday, are essentially tied in national opinion polls with fewer than five months until the November 5 election
Many major shareholders and some smaller ones voted against the pay package, frustrated by the size of the award, slowing business at Tesla and Musk's growing list of distractions
Even though the Fed sees only 25 bps of cut, the futures market is pricing in 44 bps of cuts in 2024
The head of the UN refugee agency says he understands that the Biden administration enacted new restrictions on asylum-seekers entering the United States, but cautioned that some aspects of the executive order may violate refugee protection required in international law. Filippo Grandi, the UN high commissioner for refugees, spoke to The Associated Press as his agency issued its annual Global Trends report for 2023 on Thursday. It found that the cumulative number of people who have been subjected to forced displacement rose to 120 million people in 2023 6 million more than in the year before. The refugee agency noted that the total count was roughly equivalent to the entire population of Japan. The UNHCR report found that three-fourths of those people forcibly displaced including both refugees driven abroad and people displaced inside their own countries lived in poor or middle-income countries. Grandi insisted that was a sign of how migrant and refugee flows were not just an iss
A coalition of immigrant advocacy groups sued the Biden administration on Wednesday over President Joe Biden's recent directive that effectively halts asylum claims at the southern border, saying it differs little from a similar move during the Trump administration that was blocked by the courts. The lawsuit filed by the American Civil Liberties Union and others on behalf of Las Americas Immigrant Advocacy Center and RAICES is the first test of the legality of Biden's sweeping crackdown on the border, which came after months of internal White House deliberations and is designed in part to deflect political attacks against the president on his handling of immigration. By enacting an asylum ban that is legally indistinguishable from the Trump ban we successfully blocked, we were left with no choice but to file this lawsuit, said Lee Gelernt, an attorney for the ACLU. The order Biden issued last week would limit asylum processing once encounters with migrants between ports of entry .