PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. home health visits).

FDA 104

FDA Food and Drug Administration Safety Medicine 104

European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

Food and Drug Administration 84

Food and Drug Administration FDA Food Medicine 84

Pharmaceutical Technology

MAY 3, 2023

PharmaTher has submitted a fast track application for Ketarx (ketamine) to the US Food and Drug Administration (FDA) to treat levodopa-induced dyskinesia in Parkinson’s disease (LID-PD). No adverse events were observed after infusion.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

JUNE 24, 2022

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The vaccine showed an encouraging safety and tolerability profile in both trials.

Food and Drug Administration 105

Food and Drug Administration FDA Engineering Food 105

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. A milestone for retinal ophthalmology The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade.”

FDA 82

FDA Food and Drug Administration Food Leads 82

European Pharmaceutical Review

DECEMBER 2, 2022

has announced the US Food and Drug Administration (FDA) has approved its oral drug Rezlidhia (olutasidenib) for adults with relapsed or refractory (R/R) acute myeloid leukaemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation. Clinical safety data of Rezlidhia for AML.

FDA 76

FDA Food and Drug Administration Food Patients 76

Pharmaceutical Technology

JUNE 27, 2022

Bristol Myers Squibb (BMS) has received approval from the US Food and Drug Administration (FDA) for its CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel) to treat relapsed or refractory large B-cell lymphoma (LBCL) in adult patients.

Food and Drug Administration 105

Food and Drug Administration FDA Food Safety 105

PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

European Pharmaceutical Review

DECEMBER 19, 2022

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours.

FDA 87

FDA Food and Drug Administration Food Patients 87

World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. We need a 21st-century approach that puts patient safety first.

Food and Drug Administration 187

Food and Drug Administration Prescription Pharma Manufacturing 187

Pharmaceutical Technology

FEBRUARY 8, 2023

The US Food and Drug Administration (FDA) has accepted Aldeyra Therapeutics’ new drug application (NDA) for topical ocular reproxalap to treat signs and symptoms of dry eye disease. The regulator has assigned 23 November 2023 as the Prescription Drug User Fee Act (PDUFAs) date for its decision.

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

Pharma Leaders

JUNE 21, 2023

The US Food and Drug Administration (FDA) has accepted bluebird bio’s Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy and granted priority review for the product’s use in the treatment of sickle cell disease (SCD). We look forward to working with the agency on its review.”

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

APRIL 28, 2023

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022.

Food and Drug Administration 105

Food and Drug Administration Engineering Patients Food 105

Pharmaceutical Technology

APRIL 20, 2023

The US Food and Drug Administration (FDA) has approved Roche ’s Polivy (polatuzumab vedotin-piiq), along with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP), to treat certain types of previously untreated diffuse large B-cell lymphoma (DLBCL) in adult patients.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

AUGUST 30, 2022

The US Food and Drug Administration (FDA) has accepted Sanofi ’s efanesoctocog alfa (BIVV001) Biologics License Application (BLA), to treat haemophilia A, for priority review. Headache, arthralgia, fall and back pain were the most frequent treatment-emergent adverse events seen in the trial.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

NOVEMBER 7, 2022

has announced its B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) elranatamab for relapsed or refractory multiple myeloma (RRMM) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The investigation noted elranatamab delivered a manageable safety profile.

Food and Drug Administration 91

Food and Drug Administration Medicine Safety FDA 91

Legacy MEDSearch

OCTOBER 9, 2023

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. FDA authorization was based, in part, on data from the #HOPE4LIVER Trials in 13 trial sites across the US and Europe. Are you hiring?

FDA 52

FDA Food and Drug Administration Physicians Safety 52

pharmaphorum

JANUARY 12, 2023

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). The post Avillion, AstraZeneca asthma rescue treatment given FDA approval appeared first on.

FDA 52

FDA Food and Drug Administration Medical Patients 52

Pharmaceutical Technology

AUGUST 5, 2022

The diabetic macular oedema (DME) space recently witnessed a new approval; the US Food and Drug Administration (FDA) announced the approval of Coherus’ Cimerli (ranibizumab-eqrn; FYB201), a vascular endothelial growth factor (VEGF) inhibitor therapy.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Insurance 52

European Pharmaceutical Review

AUGUST 3, 2023

The optimised framework aims to overall, drive higher product quality and improved patient safety. Essentially, the risk-based framework pushes developers of medical devices to emphasise high-risk issues, like ones that impact product quality, instead of all events.

Food and Drug Administration 52

Food and Drug Administration Medical Management FDA 52

Pharmaceutical Technology

MAY 12, 2023

Editas Medicine will release new efficacy and safety results of its gene therapy EDIT-301 in severe sickle disease as part of an oral presentation at the European Hematology Association’s (EHA) Hybrid Congress. Last month, the US Food and Drug Administration (FDA) granted the treatment an orphan drug designation for sickle cell disease.

Food and Drug Administration 98

Food and Drug Administration Food Patients Safety 98

Legacy MEDSearch

APRIL 11, 2023

Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. I’m excited that the study met its superiority composite endpoint, which included effectiveness and safety components. Moximed is based in Fremont, California.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

Pharmaceutical Technology

JUNE 8, 2023

While the company previously shared interim biomarker and safety data from the Phase I/II AEROW trial (NCT05248230) in November 2022, the update features further results detailing the drug’s effects on quality-of-life and spirometry-measured outcomes in a limited set of patients.

Patients 98

Patients Food and Drug Administration Food Safety 98

Clarivate

NOVEMBER 13, 2023

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. The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them.

Patients 52

Patients Food and Drug Administration FDA Safety 52

Pharmaceutical Technology

AUGUST 17, 2008

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? This higher threshold, although not explicit, would also be expected to slow drug approvals.

Food and Drug Administration 52

Food and Drug Administration Food FDA Safety 52

European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful.

Medical 81

Medical Food and Drug Administration Pharmacology Medicine 81

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics.

Food and Drug Administration 91

Food and Drug Administration Patients Leads Side effects 91

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics.

Food and Drug Administration 90

Food and Drug Administration Patients Leads Side effects 90

Pharmaceutical Technology

APRIL 25, 2023

After missing the previous Q1 deadline, bluebird bio has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its sickle cell disease gene therapy lovo-cel, based on an April 24 company announcement.

Food and Drug Administration 52

Food and Drug Administration Patients Pharmaceutical Food 52

European Pharmaceutical Review

DECEMBER 28, 2023

We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. These efficacy results, combined with the safety profile that allows patients to complete their treatment regimen, are extremely encouraging.

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products. percent) to be noncompliant.

FDA 86

FDA Food and Drug Administration Manufacturing Product sample 86

Legacy MEDSearch

JULY 11, 2022

based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. We intend to work closely with the FDA to determine a timely pathway to bring the SING IMT to market in the United States.”.

Food and Drug Administration 52

Food and Drug Administration Recruitment FDA Patients 52

European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. Safety data for up to two years is included in the analysis.

Safety 95

Safety Food and Drug Administration Prospecting Food 95

pharmaphorum

JANUARY 25, 2023

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

Food and Drug Administration 84

Food and Drug Administration Prescription Media Patients 84

Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. Indicated for administration rectally, Rebyota is a single-dose 150ml microbiota suspension. .

Food and Drug Administration 105

Food and Drug Administration FDA Food Pharmaceutical 105

European Pharmaceutical Review

DECEMBER 12, 2023

The US Food and Drug Administration (FDA) has approved two landmark cell-based gene therapies for treatment of inherited blood disorder sickle cell disease. Developed by Vertex Pharmaceuticals and CRISPR Therapeutics, Casgevy is the first FDA-approved therapy to use CRISPR/Cas9 genome editing technology.

Food and Drug Administration 89

Food and Drug Administration FDA Safety Food 89

Legacy MEDSearch

FEBRUARY 3, 2023

Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers. The X1 also has a state-of-the-art anatomic modality previously cleared by the FDA for solid tumors located anywhere in the body.

FDA 97

FDA Food and Drug Administration Recruitment Medical 97