Fierce Pharma

MARCH 5, 2024

Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. regulator, the FDA has crushed Vanda’s bid.

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FDA 97

STAT

DECEMBER 14, 2023

The increase in recalls started in 2019 and continued growing steadily during and after the pandemic, reaching a peak in 2022. The higher volume of recalls can mostly be attributed to the FDA. The product categories most commonly recalled by the FDA were food and beverages (64%) and drugs (22%). In 2022, it recalled 310.

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FDA 114

Pharmacy Times

JUNE 27, 2022

The FDA approved the first vaccine for dengue disease in May 2019.

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Vaccines FDA 136

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. It issued a draft guidance in 2017 which was subsequently revised in 2019.

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FDA Labelling 98

STAT

SEPTEMBER 5, 2024

Around 6% of middle and high school students used vapes in 2024, down from 8% last year, and a record high of 20% in 2019, according to a survey released Thursday by the FDA and the CDC. The vape brand Juul fueled this surge, but has since receded in popularity after FDA actions and legal challenges. Read the rest…

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FDA 137

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. Specifically, there was a 79% drop in inspections of pharmaceutical manufacturing plants in foreign countries and a 35% decline in domestic facilities from 2019 to 2022.

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FDA 111

Fierce Pharma

APRIL 23, 2024

Dating to a 2019 clinical hold of a phase 3 trial, getting its gene therapy ra | Dating to a 2019 clinical hold, getting its gene therapy pz-cel across the FDA finish line has been a challenge for troubled Abeona Therapeutics. Now the wait continues as the FDA has rejected the treatment due to CMC issues.

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FDA 80

pharmaphorum

APRIL 19, 2022

GlaxoSmithKline says the FDA has started its review of daprodustat for anaemia associated with chronic kidney disease (CKD), as it strives to succeed where two other rivals in the HIF-PHI class have failed. The post GSK goes for gold as FDA starts review of daprodustat appeared first on.

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FDA 122

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. In 2019, there were 40 million individuals with bipolar disorder worldwide. Clinical trials of the FDA approved Rykindo ®. Rykindo ® is an atypical antipsychotic developed by Luye Pharmaceutical.

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FDA Labelling 122

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application.

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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. Google – which acquired Fitbit for $2.1

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FDA 122

STAT

DECEMBER 7, 2023

In 1997, Celgene obtained a key patent for what would become a blockbuster blood cancer treatment, giving it a monopoly until 2019. But like any pharmaceutical company with an eye toward the future, Celgene continued to seek other ways to wring profits from its development work.

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FDA Compounding Pharmaceutical Companies Pharmaceutical Companies 128

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

pharmaphorum

APRIL 22, 2022

Ampio Pharma’s candidate therapy for knee osteoarthritis has been knocked back by the FDA, which will likely now require a new clinical trial of the drug before it will consider a review. The FDA said it should have been advised of the proposed changes before Ampio unblinded and analysed the data from the AP-013 study.

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Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. SYNB1934 has also gained rare paediatric disease designation (RPDD) from the FDA and orphan drug designation from the European Medicines Agency (EMA).

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FDA 104

pharmaphorum

DECEMBER 9, 2020

Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck. The post Sanofi/Regeneron on notice as FDA reviews GSK’s Nucala for nasal polyps appeared first on.

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FDA 111

Pharmaceutical Technology

AUGUST 8, 2022

AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer.

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FDA Chemotherapy Labelling 105

European Pharmaceutical Review

MAY 19, 2023

This finding alongside the other data from the trial led the US Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee to recommend the FDA approve the combination antibiotic for often-fatal pneumonia strain carbapenem-resistant Acinetobacter baumannii–calcoaceticus complex (ABC).

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Hospitals FDA Medical Schools 105

pharmaphorum

JULY 20, 2021

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. “Despite….advantageous “Despite….advantageous

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pharmaphorum

NOVEMBER 24, 2021

Takeda has scored the first-ever FDA approval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased risk of complications and even death. It was one of the drugs acquired by Takeda when it merged with Shire in 2019.

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FDA 105

STAT

SEPTEMBER 6, 2024

drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U.S. and previously underwent FDA review before May 2019. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. An analysis of U.S.

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FDA 102

pharmaphorum

DECEMBER 6, 2022

Pfizer and BioNTech have announced that they have submitted an Emergency Use Authorisation (EUA) to the US Food and Drug Administration (FDA) for their Omicron BA.4/BA.5-adapted It is also FDA-authorised under an EUA as a third primary series dose in individuals 12 years old and above who have certain kinds of immunocompromises.

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Vaccines FDA Immunization 105

The FDA Law Blog

SEPTEMBER 30, 2022

Valentine — On September 29, 2022, FDA approved Amylyx’s NDA for its drug, Relyvrio (sodium phenylbutyrate/taurursodiol), for treatment of patients with amyotrophic lateral sclerosis (ALS) (see FDA announcement here ). We would like to acknowledge FDA for its efforts on this devastating condition, ALS. By Frank J.

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FDA 98

pharmaphorum

MARCH 14, 2022

AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal polyps, after the FDA rejected its marketing application. The post FDA says no to AZ’s Fasenra for nasal polyp indication appeared first on. billion from the drug last year.

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FDA 116

The Checkup by Singlecare

OCTOBER 30, 2023

Food and Drug Administration (FDA) approved Zituvio (sitagliptin) for adults with Type 2 diabetes. This approval is noteworthy because in 2022 the FDA found nitrosamine impurities in certain samples of sitagliptin , raising concerns about potential shortages of these two drugs.

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FDA Dosage 98

pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. That status goes to Johnson & Johnson’s Spravato (esketamine), which was approved in March 2019 and is administered as a nasal spray twice a week for four weeks.

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FDA Labelling 98

Pharmaceutical Technology

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has granted approval for bluebird bio ’s Zynteglo (betibeglogene autotemcel, beti-cel) for the treatment of the underlying genetic cause of beta?thalassemia The post FDA grants approval for bluebird’s Zynteglo to treat beta-thalassemia appeared first on Pharmaceutical Technology.

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FDA Labelling 98

Pharmaceutical Technology

SEPTEMBER 30, 2022

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

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FDA Insurance 115

pharmaphorum

APRIL 19, 2022

AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu for non-small cell lung cancer (NSCLC) and add to its current uses in breast and gastric cancer. billion licensing deal for the drug in 2019.

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FDA Chemotherapy 105

Pharmaceutical Technology

SEPTEMBER 19, 2022

The US Food and Drug Administration (FDA) has awarded Accelerated Approval for bluebird bio ’s Skysona (elivaldogene autotemcel; eli-cel) for slowing neurologic dysfunction progression in early, active cerebral adrenoleukodystrophy (CALD) patients. The treatment is indicated for usage in boys aged four to 17 years with CALD. thalassemia.

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FDA Adverse Reactions Labelling 98

STAT

SEPTEMBER 5, 2024

drug supply are still struggling to get back to where they were in 2019, before the  Covid-19 pandemic  upended  factory inspections in the U.S.  and Federal regulators responsible for the safety of the U.S.  and across the world, The Associated Press has found.

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FDA 105

pharmaphorum

SEPTEMBER 30, 2021

Now, the FDA has published its first take on sourcing real-world data (RWD) from EHRs and medical claims, setting out its thinking on the approach that should be used to support regulatory filings for medicines. The FDA stresses it is a preliminary document and is encouraging comments, which can be filed up to 60 days after publication.

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FDA Documentation Insurance 95

European Pharmaceutical Review

AUGUST 25, 2023

The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. In 2019, Sandoz entered into a global commercialisation agreement for Tyruko with Polpharma Biologics. Tyruko (natalizumab-sztn) is a biosimilar to Tysabri (natalizumab) injection for adults with relapsing forms of MS.

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FDA 98

pharmaphorum

AUGUST 4, 2021

The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).

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FDA Chemotherapy Labelling 98

pharmaphorum

JULY 29, 2021

The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer and Regeneron’s market-leading Eylea. Beovu launched in October 2019 in the US with sales predictions of $2.5 billion in sales for Roche last year and $1.9

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FDA 98

The FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

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FDA Documentation 115

pharmaphorum

JULY 20, 2021

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson’s disease which is currently in early-stage clinical testing. The post FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy appeared first on.

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FDA Communication Immunization 98