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 467

Drug Topics

FEBRUARY 19, 2025

The FDA also granted priority review, with a Prescription Drug User Fee Act target action date of August 19, 2025.

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FDA 463

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

APRIL 24, 2023

The FDA is hoping these warnings are a positive step in what will be an extremely long process of ending opioid related deaths.

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FDA 469

Drug Topics

MARCH 7, 2023

The test is intended to complement the company’s TBI plasma test, which received FDA clearance in 2021.

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FDA 503

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.

FDA 467

FDA 467

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

MARCH 27, 2024

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

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FDA 407

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.

FDA 469

FDA 469

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

JUNE 18, 2024

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

Vaccines 386

Vaccines FDA 386

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.

FDA 462

FDA 462

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

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

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

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 281

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 143

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?

Compounding 98

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.

FDA 387

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

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

Drug Topics

JULY 2, 2024

Donanemab-azbt was approved under the FDA's Fast Track Review, Priority Review, and Breakthrough Therapy designations.

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FDA 307

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 130

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.

FDA 346

FDA 346

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

APRIL 23, 2024

Abeona Therapeutics’ pz-cel is an investigational autologous, COL7A1 gene-corrected epidermal sheet therapy for the treatment of recessive dystrophic epidermolysis bullosa.

FDA 521

FDA 521

Drug Topics

FEBRUARY 21, 2025

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

FDA 281

FDA 281

Drug Topics

MAY 1, 2024

According to Michael Osso, president and chief executive officer of the Crohn’s & Colitis Foundation, “the flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicine.”

FDA 503

FDA 503

Drug Topics

AUGUST 2, 2024

The technology from Diakonos Oncology initiates a natural immune response that targets and eliminates cancer cells by activating cytotoxic TH1 cell signaling pathways.

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Immunization Vaccines FDA 526

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

Drug Topics

MARCH 27, 2024

The agency issued warning letters to 6 companies manufacturing these products.

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FDA 503

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…

Compounding Pharmacies 134

Compounding Pharmacies FDA Compounding 134

Drug Topics

SEPTEMBER 25, 2024

The approval comes shortly after the FDA approved arimoclomol from Zevra Therapeutics to treat neurological manifestations of the disease in combination with miglustat.

FDA 281

FDA 281

Drug Topics

SEPTEMBER 22, 2023

This is the fourth approval for the drug, stemming from the EMPOWER clinical trial program.

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FDA 502

Drug Topics

JULY 30, 2024

The new FDA-approved presentation will be the company’s third 505(b)(2) injectable added in 2024, expected to launch in the third quarter.

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FDA 281