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The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in patients with alkaptonuria (AKU). The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in patients with alkaptonuria (AKU). The medication is expected to launch in July 2025. REFERENCES 1.
The FDA approved telmisartan, amlodipine and indapamide (Widaplik) for the treatment of hypertension in adult patients, George Medicines said in a release. The FDA approved telmisartan, amlodipine and indapamide (Widaplik) for the treatment of hypertension in adult patients, George Medicines said in a release. References 1.
A new pilot program announced by FDA Commissioner Dr. Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.
The FDA has mandated that companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy program provide pre-paid mail-back envelopes for unused or expired opioid medications.
Following quality concerns voiced by the FDA regarding plastic syringes made in China, medical technology company BD has announced it will increase its production of plastic syringes in the US.
An NDA has been submitted to the FDA. The drug, called Lumisight, is an optical imaging agent that detects cancerous tissue during initial lumpectomy to allow for a more complete resection.
The FDA granted the EUA based on the phase 3 trial results that demonstrated vilobelimab's efficacy compared to placebo, with a 23.9% relative reduction in all-cause mortality from COVID-19 at 28 days.
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.
The FDA approved adalimumab-aaty in May 2023 for 8 indications, including rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis.
A 510(k) clearance, or a Premarket Notification, requires device manufacturers to notify the FDA at least 90 days ahead of registration with their intent to market a medical device.
The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial of the vaccine was initiated in November 2024.
FDA drug, medical device, or food reviewers and inspectors will not be among those fired, according to an HHS fact sheet. The layoffs will shrink the FDA by almost 20%. WASHINGTON — Around 3,500 employees are on the chopping block at the Food and Drug Administration, but they don’t yet know who they are.
Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA.
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?
Scores of FDA employees are searching for an exit from an agency in turmoil, particularly staff members tasked with reviewing drug applications, according to interviews with former employees and industry recruiters. Kennedy Jr. But his department’s actions now seem to be causing that door to spin ever faster.
The FDA acceptance marks the first step in addressing the unmet need for a lasting treatment option for patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
1 "Lilly was the first company to offer a self-pay solution for an FDA-approved obesity medication, and we continue to work to expand coverage for Zepbound. mg and 15 mg vials of tirzepatide starting July 7, with shipments beginning in early August. .
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
Tenofovir alafenamide was originally approved by the FDA in 2016 to treat adults with chronic HBV infection with compensated liver disease and in 2022 to treat pediatric patients aged 12 years and older.
The FDA expressed concern, specifically, about in-vitro studies, which are run to test biological processes. The agency identified “significant” problems with data integrity and the way studies were conducted by Raptim Research, which had been hired by the drugmakers to test their medicines.
Prasad, previously an epidemiology professor at the University of California, San Francisco, has sharply criticized the FDA in the past, including the Center for Biologics Evaluation and Research, the unit he will now lead. After reports of his appointment, the S&P Biotech ETF extended losses, tumbling more than 5%.
The US Food and Drug Administration (FDA) has for the first time, issued draft guidance on using artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product. FDA has previously published a discussion paper that was produced to inform its guidance on AI in pharmaceutical drug development.
Commissioner Marty Makary has hailed the potential of the AI at the FDA, saying it could save employees time and ultimately speed up regulatory reviews. “When I announced earlier this month that I was launching an aggressive AI timeline for the agency, I meant it,” he says in the draft release.
Food and Drug Administration (FDA) announced its approval of the first generic form of Xarelto (rivaroxaban), a popular anticoagulant medication. To gain FDA approval , a generic medication must be proven to work the same and provide the same benefits as the brand-name medication. On March 4, 2025, the U.S. The approval is for the 2.5
With all doses now listed as available, the FDA may soon pull it off the list, depending on its conversations with Novo about whether the company can sufficiently meet demand going forward. Continue to STAT+ to read the full story…
For the first time in over ten years, the US Food and Drug Administration (FDA) has approved a new targeted treatment for chronic spontaneous urticaria. Why is the FDA’s decision to approve Dupixent as a new treatment for chronic spontaneous urticaria significant?
Abeona Therapeutics’ pz-cel is an investigational autologous, COL7A1 gene-corrected epidermal sheet therapy for the treatment of recessive dystrophic epidermolysis bullosa.
Moderna's mRNA-1345 vaccine gains FDA approval, enhancing protection against RSV for high-risk adults aged 18 to 59, following earlier approvals for older populations.
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