Articles for Fda Approval

Pinnacle Life Science, a Subsidiary of Aarti Drugs Ltd, Enters the US Market with FDA Approval
4 months, 2 weeks ago

Pinnacle Life Science, a Subsidiary of Aarti Drugs Ltd, Enters the US Market with FDA Approval

Hindustan Times  

Mumbai, India, August 2nd: Pinnacle Life Science, a Subsidiary of Aarti Drugs Ltd, achieved a significant milestone on July 29, 2024. FDA Approval for Pinnacle's Oncology Facility at Baddi Sets Stage for the US Market Entry Leading oncology hubs in the countries are focusing more on the growth and development of products, quality R&D, and the highest standards of ethics …

India Market Drugs Life Hindustan Times Facility Fda
Medicare can now cover Wegovy for more senior citizens
9 months ago

Medicare can now cover Wegovy for more senior citizens

CNN  

CNN — Medicare could start covering Wegovy for certain senior citizens and other beneficiaries with a history of heart disease now that the US Food and Drug Administration has approved drugmaker Novo Nordisk’s application to add cardiovascular benefits to the medicine’s label. The Centers for Medicare and Medicaid Services said it has informed insurers that provide Medicare Part D drug …

Medicare Cardiovascular Disease Cardiovascular Cnn Approval Medicaid Fda
Woman will suffer diarrhea FOREVER after Ozempic caused horror bowel injury - and weight loss drug made another vomit until her teeth fell out, claim dozens of lawsuits saying maker failed to warn of
11 months, 1 week ago

Woman will suffer diarrhea FOREVER after Ozempic caused horror bowel injury - and weight loss drug made another vomit until her teeth fell out, claim dozens of lawsuits saying maker failed to warn of

Daily Mail  

A woman who will suffer diarrhea for the rest of her life after using Ozempic is among dozens of patients who are suing the maker of the blockbuster weight loss drug over claims it left them with crippling stomach paralysis, a DailyMail.com investigation reveals. Brea Hand, 23, told DailyMail.com she required five hospital visits before doctors diagnosed her with gastroparesis …

Weight Loss Loss Drugs Diabetes Patient Safety Weight Ozempic
US appeals court upholds limits on access to abortion pill mifepristone
1 year, 4 months ago

US appeals court upholds limits on access to abortion pill mifepristone

Al Jazeera  

The latest ruling over mifepristone’s FDA approval is likely to send the pill’s fate to the US Supreme Court. A United States appeals court has struck the latest blow in an ongoing battle over the pill mifepristone, often used in medication-induced abortions On Wednesday, the three-judge Fifth Circuit Court of Appeals in New Orleans overturned a lower court’s wholesale revocation …

Abortion Court Texas Drug Ruling Approval Mifepristone
New drug to protect babies and toddlers from RSV gets FDA approval ahead of cold season
1 year, 5 months ago

New drug to protect babies and toddlers from RSV gets FDA approval ahead of cold season

Associated Press  

WASHINGTON — U.S. officials on Monday approved the first long-acting drug to protect babies and toddlers against a respiratory virus that sends tens of thousands of American children to the hospital each year. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system” said FDA’s Dr. …

Children Drug Fda Pfizer Fda Approval Beyfortus Rsv Gets
Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it
1 year, 5 months ago

Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it

Associated Press  

WASHINGTON — U.S. officials granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease. The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer’s disease. “This confirmatory …

Medicare Patients Drug Approval Fda Leqembi Eisai
Alzheimer's drug Leqembi gets full FDA approval. Medicare coverage will likely follow
1 year, 5 months ago

Alzheimer's drug Leqembi gets full FDA approval. Medicare coverage will likely follow

NPR  

Alzheimer's drug Leqembi gets full FDA approval. Medicare coverage will likely follow Enlarge this image toggle caption Andrew Harnik/AP Andrew Harnik/AP The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer's disease. In January, the drug received what's known as accelerated approval from the FDA, based on its ability to remove the substance beta-amyloid …

Disease Medicare Patients Drug Approval Fda Susan
Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it
1 year, 5 months ago

Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it

LA Times  

This image provided by Eisai in January 2023 shows vials and packaging for their medication, Leqembi. On Thursday, U.S. officials granted full approval to the closely watched Alzheimer’s drug, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease. U.S. officials granted full approval to a closely watched Alzheimer’s drug …

Medicare Brain Patients Drug Approval Fda Leqembi
Elon Musk's Neuralink gets FDA approval for study of brain implants in humans
1 year, 6 months ago

Elon Musk's Neuralink gets FDA approval for study of brain implants in humans

The Hindu  

Elon Musk's brain-implant company Neuralink on Thursday said it had received the U.S. Food and Drug Administration's approval to launch its first-in-human clinical study. On at least four occasions since 2019, Musk has predicted that his medical device company would soon start human trials of a brain implant to treat intractable conditions such as paralysis and blindness. The FDA approval …

Musk Reuters Fda Neuralink Fda Approval Humans Elon
Elon Musk’s Neuralink brain implant firm cleared for human trials
1 year, 6 months ago

Elon Musk’s Neuralink brain implant firm cleared for human trials

Al Jazeera  

Neuralink cleared by US FDA to study implant allowing interface between human brains and computers. United States regulators have given approval for Elon Musk’s start-up Neuralink to test its brain implants on people. Neuralink said on Thursday that it received clearance from the US Food and Drug Administration for the first human clinical study of implants which are intended to …

Musk Fda Implant Human Clinical Neuralink Brain Study Neuralink Brain Interface
Musk’s brain implant firm says U.S. approves human tests
1 year, 6 months ago

Musk’s brain implant firm says U.S. approves human tests

LA Times  

Elon Musk has for years said that Neuralink was close to FDA approval for in-human trials. Neuralink, Elon Musk’s brain-implant company, said it received approval from the U.S. Food and Drug Administration to conduct human clinical trials. Musk, who also runs electric-car maker Tesla and owns social network Twitter, has for years said that the company was close to FDA …

Brain Company Human Approval Fda Device Implant
Science fiction becomes reality: Elon Musk's Neuralink receives FDA approval for human brain implants
1 year, 6 months ago

Science fiction becomes reality: Elon Musk's Neuralink receives FDA approval for human brain implants

India TV News  

In a groundbreaking development, Elon Musk's company Neuralink has obtained approval from the USFDA to conduct the world's first human trials of brain implants. Elon Musk's start-up Neuralink has announced a significant milestone as it received approval from the US Food and Drug Administration for conducting human trials of brain transplants. Elon Musk previously highlighted during a presentation in December …

Musk Elon Musk Human Approval Human Trials Fda Approval Brain Implants
Elon Musk's Neuralink gets FDA approval for study of brain implants in humans
1 year, 6 months ago

Elon Musk's Neuralink gets FDA approval for study of brain implants in humans

ABC  

Elon Musk's brain-implant company Neuralink says it has received a green light from the US Food and Drug Administration to kickstart its first-in-human clinical study, a critical milestone after earlier struggles to gain approval. Key points: Neuralink, which was founded in 2016, sought FDA approval for the first time in early 2022 Back then the agency rejected the application, former …

Musk Elon Musk Reuters Fda Fda Approval Neuralink Gets
Poll: Two-thirds oppose banning medication abortion
1 year, 8 months ago

Poll: Two-thirds oppose banning medication abortion

NPR  

Poll: Two-thirds oppose banning medication abortion Enlarge this image toggle caption Allen G. Breed/AP Allen G. Breed/AP Strong majorities of Americans oppose laws banning medication abortion, disagree with judges overturning Food and Drug Administration approval of prescription drugs, don't have much confidence in the Supreme Court and don't think justices should serve lifetime appointments, according to the latest NPR/PBS NewsHour/Marist …

Abortion Court Confidence Gop Poll Supreme Republicans
Supreme Court blocks lower court decision in case on FDA approval of abortion pill
1 year, 8 months ago

Supreme Court blocks lower court decision in case on FDA approval of abortion pill

NPR  

Supreme Court blocks lower court decision in case on FDA approval of abortion pill Enlarge this image toggle caption Jacquelyn Martin/AP Jacquelyn Martin/AP The U.S. Supreme Court on Friday blocked lower court decisions banning or limiting the FDA-approved use of the abortion pill mifepristone for the foreseeable future. President Biden on Friday said that his administration will continue to defend …

Supreme Court Abortion Court Case Rules Biden Drug
Supreme Court extends access to abortion pill to Friday
1 year, 8 months ago

Supreme Court extends access to abortion pill to Friday

Associated Press  

WASHINGTON — The Supreme Court is leaving women’s access to a widely used abortion pill untouched until at least Friday, while the justices consider whether to allow restrictions on the drug mifepristone to take effect. At stake now is whether to allow restrictions on mifepristone ordered by a lower court to take effect while a legal challenge to the medication’s …

Supreme Court Abortion Court States Texas Case Drug
The Anti-Abortion Movement Just Made a Powerful New Enemy
1 year, 8 months ago

The Anti-Abortion Movement Just Made a Powerful New Enemy

Slate  

For decades, the pharmaceutical and biotech industry tried to avoid the politics of abortion. U.S. District Judge Matthew Kacsmaryk’s lawless and unprecedented decision ordering the Food and Drug Administration to revoke approval of mifepristone, the first drug in a medication abortion, poses an existential threat to the entire industry: If upheld, the order would allow any doctor to file a …

Abortion Industry Judge Biopharma Drug Approval Federal Court
US judge withdraws approval for abortion pill during Texas case
1 year, 8 months ago

US judge withdraws approval for abortion pill during Texas case

Al Jazeera  

Judge Matthew Kacsmaryk has placed a temporary stay on the FDA approval for mifepristone, used in medication abortions. “Before Plaintiffs filed this case, FDA ignored their petitions for over 16 years.” Kacsmaryk, an appointee of former Republican President Donald Trump, has yet to rule on the plaintiffs’ overall lawsuit. In a February statement, the pro-abortion group NARAL wrote: “If FDA …

Abortion Democratic Texas Case Judge Biden Ruling
Elon Musk's Neuralink should be disqualified from FDA approval, advocacy groups says
2 years ago

Elon Musk's Neuralink should be disqualified from FDA approval, advocacy groups says

Daily Mail  

An advocacy group of more than 17,000 doctors has petitioned the Food and Drug Administration to disqualify Elon Musk's Neuralink from receiving approval for its brain implant. Some of the animal's deaths were at the hands of Matthew McDougall, the head neurosurgeon, who administered nearly six times the amount of an unapproved 'toxic' substance that led to a monkey's death, …

Elon Musk Davis Fda Morrison Notes Merkley Neuralink
Google-owned Fitbit Gets US FDA Approval For This Popular Apple Watch Health Feature
2 years, 8 months ago

Google-owned Fitbit Gets US FDA Approval For This Popular Apple Watch Health Feature

News 18  

Google-owned wearable brand Fitbit on Monday received clearance from the US Food and Drug Administration for its new health feature that can detect atrial fibrillation — a health tool that made Apple Watch highly popular and which has saved several lives in the past. The Fitbit PPG-based algorithm and Irregular Heart Rhythm Notifications feature will soon be available to consumers …

Google Heart Rhythm Ecg Fitbit Fda Approval Ppg
Column: How the FDA’s lousy judgment and a greedy drug company combined to hit Medicare members hard
3 years, 1 month ago

Column: How the FDA’s lousy judgment and a greedy drug company combined to hit Medicare members hard

LA Times  

The fallout from the Food and Drug Administration’s hasty approval of a new Alzheimer’s drug in June was predicted to be severe: Excessive pricing for a drug lacking strong evidence of effectiveness would impose heavy costs on the healthcare system nationwide, especially on Medicare. The coverage determination process is still underway, but Medicare officials said they’re duty-bound to “plan for …

Medicare Drugs Social Security Patients Premium Drug Members
Pfizer seeks US COVID vaccine approval for children aged 5 to 11
3 years, 2 months ago

Pfizer seeks US COVID vaccine approval for children aged 5 to 11

Al Jazeera  

The company says its research shows no adverse side effects for the age group, but recommends smaller doses. Pfizer has asked the United States government to approve the use of its COVID-19 vaccine for children aged five to 11. That comes as some parents and paediatricians have clamoured for coronavirus protection for children younger than 12, the current age cutoff …

Age Fda Vaccine Pfizer Dose Younger Children
Full FDA approval of Pfizer’s Covid-19 vaccine had only a modest impact on uptake. Here’s what mattered more
3 years, 2 months ago

Full FDA approval of Pfizer’s Covid-19 vaccine had only a modest impact on uptake. Here’s what mattered more

CNN  

CNN — Despite hopes that full approval of Pfizer’s Covid-19 vaccine would convince large numbers of vaccine-hesitant Americans to roll up their sleeves, a federal government analysis provided to CNN suggests approval was not a silver bullet. The data backs up what a recent poll found: While full approval might matter to some unvaccinated Americans, it’s likely not going to …

Vaccination Biden Cnn Poll Increase Vaccine Reason
US university students face back-to-campus vaccine mandates
3 years, 3 months ago

US university students face back-to-campus vaccine mandates

Al Jazeera  

Legal precedent suggests that universities can mandate vaccinations, but not every COVID-19 vaccine has received full approval from the US Food and Drug Administration, leaving a legal grey area. Yet in the same way that public health efforts like mask mandates and social-distancing measures have been politicised in the US, students’ reactions to vaccine mandates seem to largely fall along …

Vaccination University New Jersey Fda Universities Gutierrez Vaccinated