Drug Topics

MAY 6, 2024

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

FDA 199

FDA 199

Drug Topics

MAY 13, 2024

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

Labelling 201

Labelling FDA 201

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.

FDA 201

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.

FDA 199

FDA 199

PhRMA

MARCH 1, 2023

Food and Drug Administration (FDA) are in the process of considering new collaboration initiatives aimed at biopharmaceutical patents. The United States Patent and Trademark Office (USPTO) and the U.S.

FDA 207

FDA 207

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.

FDA 168

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.

FDA 302

FDA 302

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 185

FDA 185

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…

FDA 138

FDA 138

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…

FDA 145

FDA 145

Pharmaceutical Technology

JUNE 17, 2024

Novavax has sought US FDA approval for an updated JN.1 1 version of its Covid-19 vaccine, NVX-CoV2705, for individuals aged 12 years and above.

Vaccines 145

Vaccines FDA 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…

Documentation 137

Documentation FDA 137

Pharmacy Times

NOVEMBER 14, 2024

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

FDA 144

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. |

FDA 139

FDA 139

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.

Compounding 131

Compounding Compounding Pharmacies FDA Documentation 131

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.

FDA 144

FDA 144

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.

FDA 154

FDA 154

STAT

MAY 1, 2024

The results confirmed findings of earlier testing of a more limited number of samples and add weight to the FDA’s conclusion that pasteurized milk products are safe for consumption despite a widespread outbreak of cows infected with H5N1. Read the rest…

FDA 145

FDA 145

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 81

Compounding FDA Labelling Compounding Pharmacies 81

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.

FDA 134

FDA 134

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.”

Compounding 128

Compounding Compounding Pharmacies FDA 128

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. 

FDA 128

FDA 128

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.

Compounding Pharmacies 129

Compounding Pharmacies FDA Compounding 129

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.

FDA 135

FDA 135

Fierce Pharma

AUGUST 2, 2024

Adaptimmune has won accelerated FDA approval | Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade.

FDA 133

FDA 133

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.

FDA 132

FDA 132

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.

FDA 126

FDA 126

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

FDA 120

FDA 120

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.

FDA 138

FDA 138

STAT

APRIL 23, 2024

The lengthy statement the agency released does not explicitly say FDA laboratories were unable to find live virus in the milk samples, but it does state that its belief that commercial, pasteurized milk is safe to consume has not been altered by these findings.

FDA 145

FDA 145

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 208

FDA 208

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…

Compounding 127

Compounding FDA Compounding Pharmacies 127

Pharmaceutical Technology

DECEMBER 9, 2024

The US FDA has granted priority review to AstraZeneca's sBLA for Imfinzi (durvalumab) for muscle-invasive bladder cancer (MIBC) treatment.

FDA 105

FDA 105

Pharmaceutical Technology

DECEMBER 12, 2024

Sanofi has announced that its two combination vaccine candidates have received fast track status from the US FDA.

Vaccines 99

Vaccines FDA 99

Fierce Healthcare

AUGUST 6, 2024

FDA releases roster of digital health advisory committee, chaired by American College of Cardiology innovation officer ebeavins Tue, 08/06/2024 - 10:26

FDA 132

FDA 132

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.

FDA 122

FDA 122

Fierce Healthcare

AUGUST 8, 2024

Big Health, a maker of digital treatments for mental health, has clinched Food & Drug Administration (FDA) clearance of its product for insomnia, Fierce Healthcare has learned in an a | SleepioRx, its flagship digital therapeutic, is intended for the treatment of chronic insomnia and insomnia disorder as an adjunct to usual care in adults over (..)

FDA 130

FDA 130