Drug Topics

APRIL 17, 2024

Researchers were unable to find a significant benefit for patients for the majority of cancer medications given accelerated FDA approval.

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FDA 201

Drug Topics

JANUARY 24, 2024

As per US law Section 505(o)(4), the manufacturers are required to make the requested changes, respond with a modified version of the requested changes for review, or respond with a rebuttal within 30 days of the FDA's ask.

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STAT

NOVEMBER 22, 2024

  The FDA cleared Attruby to treat patients with the heart condition known as transthyretin amyloid cardiomyopathy, or ATTR-CM. The drug, known scientifically as acoramidis, will be sold by BridgeBio under the brand name Attruby. 

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FDA 144

Pharmacy Times

OCTOBER 24, 2024

The FDA announces a Class II recall for the lot #220128, which were reported to contain the presence of nitrosamine.

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FDA 168

PhRMA

OCTOBER 5, 2022

Food & Drug Administration (FDA) to keep pace with the scientific advancements happening every day in labs across the country. With these programs reauthorized for another five years, the FDA can continue doing its vital work reviewing medicines. America relies on the U.S.

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FDA 302

STAT

AUGUST 9, 2024

The company said in a statement it had received a “complete response letter” from the FDA denying its application “based on the data submitted.”  ”  It said the issues raised by the FDA echo those brought up during the ad comm meeting. Read the rest…

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FDA 145

STAT

JULY 23, 2024

Shuren, who spent 28 years at the agency, started his FDA career in the Commissioner’s Office in 1998. Shuren dramatically increased the number of medical device authorized by the FDA each year — by five-fold, according to Commissioner Rob Califf’s email announcing the news.

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FDA 145

STAT

OCTOBER 22, 2024

Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years. The FDA still has to make a decision on whether to officially place semaglutide on the lists. The agency did not immediately respond to a request for comment.

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Compounding Compounding Pharmacies FDA Documentation 145

STAT

JULY 15, 2024

Two FDA officials, Haider Warraich and Robin McKinnon, met multiple times in February to discuss regulating these edible industrial creations, such as sodas, prepackaged cookies, and most breakfast cereals. Warraich serves as a senior adviser to FDA commissioner Robert Califf. Continue to STAT+ to read the full story…

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Documentation FDA 145

STAT

AUGUST 12, 2024

When the FDA learned that a testing facility in India had submitted fraudulent data for more than 400 drugs (most of them generics), the agency should have withdrawn them from the market. The European Medicine Agency (EMA) has already suspended distribution of these 400-plus drugs.

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Drug Topics

DECEMBER 20, 2024

Zepbound from Eli Lilly is the first and only prescription medicine approved by the FDA for adults with obstructive sleep apnea and obesity.

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FDA 131

STAT

AUGUST 9, 2024

Friday’s approval comes after the FDA stalled neffy’s approval in September, asking the drugmaker for additional data. Neffy, as the product is called, is a nasal spray that delivers the same drug used to treat anaphylaxis. It is ARS’ flagship product. Read the rest…

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FDA 145

Pharmacy Times

AUGUST 9, 2024

Previously, an independent advisory panel for the FDA rejected the use of MDMA-assisted therapy for posttraumatic stress disorder (PTSD), citing concerns of the reliability of the clinical trial data.

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FDA 138

STAT

OCTOBER 22, 2024

Michelle Tarver will be the new leader of the medical devices center at the Food and Drug Administration, according to an email reviewed by STAT and sent out to FDA device staff on Tuesday afternoon. Tarver has temporarily served in the role since veteran devices head Jeffrey Shuren announced his departure in July.

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FDA 128

Pharmacy Times

NOVEMBER 14, 2024

Eladocagene exuparvovec-tneq is the first FDA-approved gene therapy for with aromatic L-amino acid decarboxylase deficiency.

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FDA 144

Fierce Healthcare

NOVEMBER 19, 2024

The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. |

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FDA 139

STAT

OCTOBER 21, 2024

He traded his government job for a high-paying position in private practice, working on behalf of clients who want an insider’s view on how to navigate the FDA — and in some cases, on how to dismantle and weaken regulations they don’t like.  Continue to STAT+ to read the full story…

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FDA 142

STAT

SEPTEMBER 19, 2024

  The FDA’s breakthrough devices program is designed to speed the path to market for novel, potentially lifesaving products. All manufacturers have to do is prove to the FDA that their product may someday “more effectively” treat or diagnose a debilitating disease.

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FDA 138

The Checkup by Singlecare

DECEMBER 19, 2024

Food and Drug Administration (FDA) is sounding the alarm about the risks of using unapproved GLP-1s. Earlier this month, the FDA posted four warning letters to companies that have introduced unapproved GLP-1s, such as semaglutide, tirzepatide, and retatrutide, into interstate commerce. But the U.S. Which companies are affected?

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Compounding FDA Labelling Compounding Pharmacies 81

Pharmacy Times

OCTOBER 22, 2024

In April 2024, the FDA approved ustekinumab-aekn as a subcutaneous injection for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

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FDA 144

STAT

OCTOBER 11, 2024

Under agency guidelines, the FDA warned at the time, compounding pharmacies would no longer be permitted to manufacture and dispense copies of the drugs.    Many compounders, telehealth companies, and patients quickly objected to the FDA’s removal of tirzepatide from the shortage list.

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Compounding Pharmacies FDA Compounding 140

STAT

OCTOBER 2, 2024

The FDA is aware of the Cassava situation, spokesperson Jeremy Kahn told me, when I asked him what the agency intended to do after the Securities and Exchange Commission last week charged Cassava and two former executives with making misleading claims about simufilam.   Finally, there is some progress to report.

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FDA 145

STAT

SEPTEMBER 26, 2024

— Food additives rarely face FDA scrutiny once they’re on the market, even those with mounting evidence of safety concerns.   The public meeting on the FDA’s campus drew dozens of food safety advocates, industry representatives, concerned citizens, and state and federal lawmakers. SILVER SPRING, Md.

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Fierce Pharma

OCTOBER 31, 2024

Less than a month after the FDA removed Eli Lilly’s tirzepatide from its shortage list, the agency has done the same for Novo Nordisk’s rival GLP-1 semaglutide, potentially signaling the end of a d | The FDA this week revised its shortage list to note that the.25

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FDA 133

Fierce Pharma

DECEMBER 17, 2024

Johnson & Johnson has received coal in its stocking from the FDA as manufacturing issues have tripped up the companys attempt to gain approval of its subcutaneous version of lung cancer drug R | The FDA has sent complete response letters to Johnson & Johnson and AstraZeneca, rejecting J&J's application for subcutaneous Rybrevant and (..)

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FDA 121

STAT

OCTOBER 25, 2024

Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years. It marked the first time experts recall the FDA changing course about a shortage decision. Continue to STAT+ to read the full story…

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Fierce Pharma

AUGUST 14, 2024

With an FDA appro | The FDA has approved Gilead's primary biliary cholangitis treatment Livdelzi. The drug, which was acquired in a $4.3 billion buyout of CymaBay Therapeutics six months ago, is the first inflammatory treatment launched by Gilead.

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FDA 137

Fierce Pharma

NOVEMBER 14, 2024

The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza.

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FDA 143

STAT

JULY 19, 2024

Yet more than a month later, ICER chief medical officer David Rind — along with others who’ve raised concerns about Lykos’ management of the trials — told STAT they’ve yet to hear from the FDA, which is set to decide by Aug. 11 whether MDMA can be used to treat post-traumatic stress disorder.

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FDA 143

STAT

OCTOBER 8, 2024

Moreover, the trade group maintained the FDA move was “unlawful,” because it failed to follow so-called rule-making procedures and provide proper notice of its plans. The FDA noted, though, that a rival drug from Novo Nordisk called Wegovy remains on the shortages list. Continue to STAT+ to read the full story…

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Compounding FDA Compounding Pharmacies 140

Fierce Pharma

OCTOBER 8, 2024

With an estimated 2 million people in the United States taking copycat vers | A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.”

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Compounding Compounding Pharmacies FDA 130

PharmaVoice

AUGUST 28, 2024

By rejecting the first MDMA therapy earlier this month, the FDA signaled to the psychedelic drug sector that the road to approval isn’t clear cut.

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FDA 134

Fierce Pharma

SEPTEMBER 23, 2024

Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis. (..)

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FDA 126

STAT

SEPTEMBER 11, 2024

This summer, the FDA expanded Sarepta Therapeutics’ accelerated approval for the Duchenne muscular dystrophy gene therapy Elevidys , despite the drug failing its Phase 3 trial. Some decried the decision, including former FDA chief scientist Luciana Borio.

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FDA 129

Pharmacy Times

NOVEMBER 21, 2024

The indication is for adults with previously treated unresectable or metastatic HER2+ (IHC+) biliary tract cancer (BTC) as detected by an FDA-approved test.

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FDA 132

Fierce Pharma

SEPTEMBER 17, 2024

An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis and Eli Lilly in early breast cancer. | An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.

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FDA 129

Fierce Pharma

DECEMBER 5, 2024

AstraZeneca has picked off another label expansion for cancer blockbuster Imfinzi as the FDA has blessed it for limited-stage small cell lung cancer.

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