Drug Topics

APRIL 3, 2025

As of April 2, 2025, liraglutide remained in shortage, with the drug first entering the FDA database on July 18, 2023.

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FDA 423

Drug Topics

MARCH 22, 2023

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.

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FDA 467

Drug Topics

MAY 6, 2024

Mycophenolate mofetil oral suspension is the only FDA-approved ready-to-use liquid formulation.

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FDA 499

Drug Topics

APRIL 6, 2023

The FDA has finally decided to withdraw approval of Makena and its generics after Covis Pharma volunteered to remove the drug from market in March.

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FDA 468

Drug Topics

MAY 13, 2024

Altuviiio was first granted approval by the FDA in February 2023.

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Labelling FDA 503

STAT

APRIL 25, 2025

  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. 

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FDA 140

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 502

Drug Topics

JANUARY 18, 2023

The FDA has approved another Tdap vaccine option for use during pregnancy to prevent pertussis, otherwise known as whooping cough.

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Vaccines FDA 469

Drug Topics

APRIL 10, 2023

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.

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FDA 469

Drug Topics

JUNE 18, 2024

The vaccine covers 8 serotypes not currently covered by any FDA-approved pneumococcal vaccines.

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Vaccines FDA 386

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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FDA 498

Drug Topics

APRIL 15, 2025

The FDA approved adalimumab-aaty in May 2023 for 8 indications, including rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis.

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FDA 380

Drug Topics

MARCH 27, 2024

The drug had previously been granted a breakthrough therapy designation by the FDA.

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FDA 407

Drug Topics

AUGUST 4, 2023

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.

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FDA 462

STAT

MARCH 27, 2025

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. 

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FDA Communication 141

Drug Topics

AUGUST 22, 2024

Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.

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Vaccines FDA 387

Drug Topics

APRIL 11, 2025

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.

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Vaccines FDA 691

STAT

MAY 6, 2025

  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%.

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Vaccines FDA 145

Drug Topics

FEBRUARY 14, 2025

The drug is the first rapid-acting insulin biosimilar product approved for use by the FDA, marking a significant milestone in diabetes treatment.

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FDA 346

The FDA Law Blog

APRIL 8, 2025

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.

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FDA Documentation Labelling 144

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 98

Drug Topics

NOVEMBER 13, 2023

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.

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FDA 387

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 336

Drug Topics

MARCH 24, 2025

The decision makes the RNAi therapeutic the only therapy approved by the FDA to treat ATTR-CM and hATTR-PN.

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FDA 315

Drug Topics

MARCH 28, 2024

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.

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FDA 387

STAT

APRIL 4, 2025

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.

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FDA Pharmaceutical Companies Pharmaceutical Companies 144

European Pharmaceutical Review

APRIL 21, 2025

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?

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FDA 105

Drug Topics

AUGUST 8, 2024

Sam Clark, MD, PhD, founder and CEO of Terran Biosciences, discusses the implications of a potential FDA approval of MDMA-assisted therapy for PTSD.

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FDA 346

Drug Topics

MARCH 5, 2024

Clobetasol propionate ophthalmic suspension 0.05% is the first ophthalmic clobetasol propionate product approved by the FDA and is the first new ophthalmic steroid on the market in over 15 years.

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FDA 346

STAT

APRIL 17, 2025

He spent much of the conversation with Kelly lambasting his agency for its ties to industry, and said he was shocked to learn that drug industry representatives are allowed to sit on FDA advisory committees. Continue to STAT+ to read the full story…

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FDA 145

European Pharmaceutical Review

JANUARY 7, 2025

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.

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FDA Patient Care 105

Drug Topics

FEBRUARY 21, 2025

Ctexli is the first FDA-approved treatment for adults with cerebrotendinous xanthomatosis.

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FDA 281

STAT

MARCH 4, 2025

3 letter posted on the FDA website this week, the Office of Prescription Drug Promotion wrote that Edenbridge Pharmaceuticals displayed a panel about its Hemady treatment for multiple myeloma in a conference exhibit booth.

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FDA 136

STAT

OCTOBER 30, 2024

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…

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Compounding Pharmacies FDA Compounding 139

The Checkup by Singlecare

MARCH 7, 2025

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

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FDA Insurance 99

STAT

DECEMBER 19, 2024

In early October, the FDA pulled Eli Lilly’s tirzepatide — sold as Mounjaro for diabetes and Zepbound for obesity — off its drug shortage list after nearly two years. Continue to STAT+ to read the full story…

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Compounding FDA Compounding Pharmacies 133

Drug Topics

AUGUST 1, 2024

Pharmacists should be knowledgeable about the symptoms of chemical peel irritation to effectively advise patients.

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FDA 524