European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). Janssen), a Johnson & Johnson company in December 2017.

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Food 98

European Pharmaceutical Review

AUGUST 18, 2023

ACP was approved by the US Food and Drug Administration (FDA) as IZERVAY (avacincaptad pegol intravitreal solution) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on 4 August 2023. This could therefore potentially slow the progression of GA.

Food and Drug Administration 97

Food and Drug Administration Medicine FDA Food 97

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

Food and Drug Administration 95

Food and Drug Administration Medical Patients FDA 95

European Pharmaceutical Review

DECEMBER 6, 2023

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). Novartis’ Factor B inhibitor, Fabhalta ® (iptacopan) provides comprehensive control of red blood cell (RBC) destruction, according to the company.

Food and Drug Administration 108

Food and Drug Administration Patients Food Physicians 108

Pharma Leaders

JUNE 7, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson is seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) from the US Food and Drug Administration (FDA) through submission of a supplemental Biologics License Application (sBLA).

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.

Food and Drug Administration 52

Food and Drug Administration FDA Food Medicine 52

Pharmaceutical Technology

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) has granted approval for Radius Health ’s Tymlos (abaloparatide) to boost bone density in men with osteoporosis at increased fracture risk. The post US FDA grants approval for Radius’ Tymlos for osteoporosis in men appeared first on Pharmaceutical Technology.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

Pharmaceutical 96

Pharmaceutical Food and Drug Administration Medicine Patients 96

Legacy MEDSearch

FEBRUARY 21, 2023

Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. Since 2017, clinicians in the U.S., Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S.

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Distribution 98

European Pharmaceutical Review

OCTOBER 19, 2023

One of the aspects of radiopharmaceuticals that is often overlooked is how complicated it is to develop a new agent, in terms of the complexity of drug design to realise a therapeutic candidate and the implementation of the clinical evaluations. This is not an effective strategy.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Side effects Doctors 105

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US. from 2001 to 2022.”

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Competition 98

Pharmaceutical Technology

JULY 11, 2022

The lead product of the company, Giapreza (angiotensin II) obtained the Food and Drug Administration (FDA) approval in December 2017. Xerava (eravacycline), another FDA-approved asset of La Jolla, is intended to treat complicated intra-abdominal infections (cIAIs) in individuals of the age 18 years and above.

Pharmaceutical 59

Pharmaceutical Food and Drug Administration Distribution FDA 59

European Pharmaceutical Review

MAY 4, 2023

Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication? They are not US Food and Drug Administration (FDA)-approved for these patients due to the lack of benefit. 2017; 8(43): 75712–26. Personalized medicine at FDA. Oral Presentation JGN-75414. Oncotarget.

Food and Drug Administration 98

Food and Drug Administration Safety Patients Medicine 98

Pharmaceutical Technology

MARCH 30, 2023

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. The drug is approved in several indications, including advanced melanoma, metastatic non-small cell lung cancer (NSCLC), and relapsed classical Hodgkin lymphoma (cHL). In 2022, the company reported Keytuda sales of $20.9 billion in 2028.

Food and Drug Administration 52

Food and Drug Administration FDA Sales Food 52

Legacy MEDSearch

MARCH 1, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., About SpectraWAVE, Inc.

Food and Drug Administration 97

Food and Drug Administration Physicians Recruitment Medical 97

Legacy MEDSearch

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. Are you hiring?

FDA 52

FDA Food and Drug Administration Healthcare Provider Recruitment 52

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

Patients 52

Patients Food and Drug Administration FDA Safety 52

European Pharmaceutical Review

DECEMBER 15, 2022

Compared to conventional antidepressant therapy that consists of daily oral administration, psilocybin therapy acts through a single-dose capsule, with repeated administration being investigated in COMPASS’ larger Phase III study. Additionally, the Phase IIb trial found that outcome was associated with dose. Available from: [link].

Food and Drug Administration 69

Food and Drug Administration Healthcare Healthcare Food 69

Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

FDA 52

FDA Food and Drug Administration Patients Prospecting 52

Pharmaceutical Technology

APRIL 24, 2023

CLL is regarded as the most common type of leukaemia in England where 3,157 patients were diagnosed with the disease in 2017, based on the institute’s announcement. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31

Food and Drug Administration 52

Food and Drug Administration Side effects Sales Food 52

European Pharmaceutical Review

JANUARY 3, 2023

In a preclinical model of cisplatin-induced ototoxicity (Petremann et al, 2017), SENS-401 demonstrated an ability to significantly reduce hearing loss. Prior study results assessing SENS-401 for cisplatin-induced ototoxicity. 70 percent of the Intent to Treat population). Previous approvals for SENS-401.

Patients 52

Patients Food and Drug Administration Side effects Food 52

Pharmaceutical Technology

JUNE 30, 2022

This will put up a barrier to the traditional system where the drugs are shipped on a direct-to-site basis straight away from the manufacturing facilities to a Georgia storage facility within the location.”. In 2017 Oximio began providing dedicated local clinical trial support from its depot in Tbilisi as well as its courier fleet.

Food and Drug Administration 52

Food and Drug Administration Distribution Recruitment Transportation 52

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). DBV expects to share topline data from the study in H1 2025.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prospecting 52

World of DTC Marketing

FEBRUARY 1, 2022

It dropped more than 15% in 2016 and followed that up with a 44% rise in 2017. Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen. introduced sweeping drug-pricing legislation. 1ne: More scrutinization by the FDA on new drug applications.

Food and Drug Administration 234

Food and Drug Administration FDA Pharmaceutical Food 234

European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). How has the autologous T-cell immunotherapy field progressed in recent years?

Food and Drug Administration 110

Food and Drug Administration Food Medical Medicine 110

European Pharmaceutical Review

OCTOBER 21, 2022

A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017. The product will be given to HIV patients whose previous HBV vaccination failed to prevent against the virus. The clinical trial is estimated to be completed in March 2023.

Patients 96

Patients Food and Drug Administration Side effects Food 96

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

Clarivate

OCTOBER 7, 2024

Food and Administration (FDA) approval, a change long sought by animal welfare organizations. Drugs can be now cleared for human trials using non-animal technologies developed over the last 10-15 years. Food and Drug Administration, 2023). Then, of course, there are the ethical considerations.

Food and Drug Administration 52

Food and Drug Administration Pharmacology Food Engineering 52

European Pharmaceutical Review

DECEMBER 21, 2023

The Lynparza combination is also approved in the EU for advanced prostate cancer , and by the US Food and Drug Administration (FDA). The post NICE recommends combination therapy for prostate cancer appeared first on European Pharmaceutical Review.

Food and Drug Administration 98

Food and Drug Administration Food Patients FDA 98

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. Not even three years later, Proteus filed for bankruptcy.

Food and Drug Administration 122

Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

APRIL 18, 2023

Members of the FDA’s Antimicrobial Drugs AdCom voted 12-0 for the drug’s potential approval based on a positive benefit-risk assessment. The agency accepted the drug’s new drug application (NDA) for priority review in November 2022. The application’s PDUFA date was set to 29 May 2023.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Food 52

European Pharmaceutical Review

JUNE 8, 2023

2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59

Legacy MEDSearch

OCTOBER 17, 2023

Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Food and Drug Administration 40

Food and Drug Administration Recruitment FDA Management 40

European Pharmaceutical Review

JUNE 28, 2022

This theory has been supported by the clinical results of drugs such as empagliflozin, the SGLT2 inhibitor, across several of these conditions. The drug advanced through to Phase II trials in adults living with obesity and also those with NASH in 2021. This programme has received FDA Fast Track designation.

Food and Drug Administration 98

Food and Drug Administration Medicine Patients FDA 98

Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season.

FDA 59

FDA Food and Drug Administration Patients Food 59

Legacy MEDSearch

SEPTEMBER 20, 2023

Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue Imaging System. is a privately held medical device company founded in 2017 to provide unrivaled optical and computational insights to improve the treatment and outcomes for patients with coronary artery disease (CAD).

Food and Drug Administration 52

Food and Drug Administration Recruitment Physicians Patients 52