pharmaphorum

MAY 18, 2022

FDA veteran Bakul Patel has joined Google as its new senior director of global digital health strategy, ending a stint at the regulator that lasted more than 13 years. Current FDA Commissioner Robert Califf spent some time as an advisor to Google parent Alphabet after his earlier stint at the head of the regulator. Bakul Patel.

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FDA 139

Fierce Pharma

DECEMBER 8, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have won an historic FDA approval for their sickle cell disease gene therapy Casgevy. Groundbreaking? Game-changing? Transformational?

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FDA 123

STAT

DECEMBER 4, 2023

Meanwhile, FDA budgeting and staffing held steady, although resources allocated for each inspection surged and more plants were cited for serious violations. For foreign facilities, about 17% of all inspections conducted the past two years yielded citations compared with just 5% in 2020.

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FDA 127

pharmaphorum

JUNE 10, 2024

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri.

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FDA 102

Fierce Pharma

APRIL 8, 2024

The FDA refused to accept Supernus' first approval bid after the company acquired the med in 2020. The third time is decidedly not the charm for Supernus and its Parkinson’s disease infusion pump. | The following year, the agency doled out a complete response letter, dashing Supernus' second try.

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FDA 99

pharmaphorum

MARCH 25, 2022

Tech giant Google has filed for FDA approval to use its Fitbit wearable to help detect atrial fibrillation (AFib), a common heart abnormality that raises the risk of heart attack, stroke and sudden death. The post Google seeks FDA nod for passive AFib detection with Fitbit appeared first on.

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FDA 122

STAT

SEPTEMBER 20, 2024

  Segan was chief medical officer at Olympus from 2020 to 2023. Olympus is a leading distributor of endoscopes and the recipient of FDA warning letters claiming the company did not adequately address product defects — including instances where endoscope caps fell into patients’ bodies.

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FDA 134

Fierce Pharma

SEPTEMBER 20, 2024

Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday.

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FDA 83

STAT

MAY 1, 2024

In March 2020, as Bauman was preparing to undergo the surgery at a Mount Sinai medical facility in midtown Manhattan, he said he was invited to participate in a research study — one only open to patients already committed to undergo DBS at Mount Sinai. The review, which lists consultations with 16 different FDA officials, was scathing.

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Documentation FDA Nursing Homes 145

The FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. FDA denied that petition in 2019.

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European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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FDA Documentation Packaging Labelling 105

The FDA Law Blog

DECEMBER 22, 2022

Koblitz — Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost. Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) passed without those sections.

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FDA Labelling 114

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. Covis Pharma added the drug to its portfolio through the acquisition of AMAG Pharmaceuticals in November 2020.

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FDA 97

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth. Covis Pharma added the drug to its portfolio through the acquisition of AMAG Pharmaceuticals in November 2020.

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FDA 95

Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

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FDA 105

pharmaphorum

JULY 6, 2021

Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. billion in 2019, and will be hoping for a swift response from the FDA to get the programme back on track and recoup its investment.

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FDA 105

Fierce Pharma

NOVEMBER 20, 2024

Roche's spinal muscular atrophy (SMA) medicine Evrysdi only gained its FDA approval in 2020, but generics companies are already eying the blockbuster as a potential target. | The spinal muscular atrophy drug is a growth driver for the Swiss pharma giant, prompting the company to prioritize its defense against potential generics.

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FDA 123

pharmaphorum

AUGUST 16, 2022

AstraZeneca and Merck & Co’s PARP inhibitor Lynparza is already used to treat prostate cancer associated with a specific genetic mutation, but could see its use broadened if a new marketing application is approved by the FDA. Rubraca was approved in 2020 for BRCA1/2 mutated mCRPC, and is in two phase 3 trials to extend its label.

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FDA Labelling 111

The Checkup by Singlecare

JANUARY 19, 2024

Food and Drug Administration (FDA) has granted the state of Florida the authority to import certain prescription drugs from Canada—an important measure to counteract soaring prescription costs. After delays that took a lawsuit to resolve, the FDA authorized the program on Jan. In a landmark decision, the U.S. an outlier?

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pharmaphorum

DECEMBER 9, 2020

The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps in the nose that can obstruct airflow and cause mucus discharge, sometimes requiring surgical intervention. The post Sanofi/Regeneron on notice as FDA reviews GSK’s Nucala for nasal polyps appeared first on.

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FDA 111

European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. This draft guidance builds on recommendations published by the agency in 2020.

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STAT

SEPTEMBER 19, 2023

This population represents less than 2% of all premature babies, but the problem is growing; the Centers for Disease Control and Prevention reported that the preterm birth rate rose by 4% between 2020 and 2021. Continue to STAT+ to read the full story…

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FDA 129

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. The post US FDA approves GSK’s Jesduvroq to treat anaemia of CKD appeared first on Pharmaceutical Technology.

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FDA 105

Pharmaceutical Technology

APRIL 4, 2023

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. Between 2020 and 2021, the number of designations increased by 600%, with seven designations being awarded by the FDA in 2021.

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FDA 98

Pharmaceutical Technology

SEPTEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) for bivalent formulations of Moderna and Pfizer -BioNTech’s Covid-19 vaccines as boosters. The EUA amendments by the FDA are based on the totality of available data. In August, Moderna sought FDA EUA for the BA.4/BA.5

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FDA Vaccines 104

pharmaphorum

AUGUST 17, 2022

The clock is now ticking on the FDA’s review of GSK’s momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 The post GSK gets June 2023 FDA decision date for momelotinib appeared first on. billion acquisition of Sierra Oncology which completed last month.

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FDA 105

STAT

JUNE 10, 2024

  In a paper published in JAMA Internal Medicine on Monday, researchers found that the percentage of women represented in high-risk medical device trials did not increase from 2010 to 2020. But stakeholders think agencies like the FDA could do more to incentivize the enrollment of women.

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FDA 140

Pharmacy Times

OCTOBER 24, 2022

The test has been available under emergency use authorization (EUA) since March of 2020 and was the first commercial molecular test to receive EUA status.

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FDA 107

pharmaphorum

AUGUST 16, 2021

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. Data from a larger phase 3 study of the third dose is also expected shortly and will be submitted to the FDA when available, said the drugmakers.

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STAT

SEPTEMBER 29, 2023

In 2020, as biotech stocks surged amid the pandemic, a startup called Taysha Gene Therapies raised over $300 million off an audacious promise: It was going to license and develop gene therapies for at least 18 different rare and serious neurological diseases. Continue to STAT+ to read the full story…

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FDA 138

STAT

MAY 11, 2023

In April 2020, the Food and Drug Administration announced a pandemic enforcement policy allowing mental health app developers to release certain treatment products without seeking authorization from the agency.

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FDA 125

STAT

JANUARY 31, 2024

Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs. I think there are definitely situations for many drugs where you can say, no, we’re not really at the right balance, and the FDA should be taking a more aggressive stance in promoting patient safety.

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Adverse Reactions FDA Labelling Hospitals 121

STAT

SEPTEMBER 13, 2023

Akili Interactive, which in 2020 made waves by receiving Food and Drug Administration clearance for its video game that improves symptoms of ADHD in children, on Wednesday announced it would reorient its business around selling its products directly to users over the counter, rather than by prescription. million in expenses.

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Labelling FDA 137

pharmaphorum

OCTOBER 24, 2022

Tremelimumab has been approved by the FDA in the US for use in tandem with AZ’s PD-L1 inhibitor Imfinzi (durvalumab) to treat adults with unresectable hepatocellular carcinoma (HCC), the most common tumour type affecting the liver. The post AstraZeneca gets first FDA okay for CTLA4 drug tremelimumab appeared first on.

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FDA 85

STAT

OCTOBER 3, 2023

Yesterday’s Nobel wins for Katalin Karikó and Drew Weissman called to mind the humble beginnings of mRNA research — and the fact that Karikó’s scientific career nearly ended before their key discovery, as she explained back in 2020. Read the rest…

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FDA 100

pharmaphorum

JUNE 7, 2021

Tecartus is already approved to treat relapsed/refractory mantle cell lymphoma (MCL), becoming the first CAR-T for that indication in mid-2020, and made sales of $31 million in the first quarter of this year. It was filed for the adult ALL indication in the US in April, and has a priority review from the FDA, with a verdict due in October.

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The FDA Law Blog

SEPTEMBER 19, 2023

Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed. But FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

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