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

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. Quizartinib had a 11.3%

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

Pharmaceutical Technology

JULY 27, 2022

The US Food and Drug Administration (FDA) has granted priority review for Biogen ’s New Drug Application (NDA) for investigational drug, tofersen, to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). An antisense drug, tofersen is being analysed to potentially treat SOD1-ALS.

Food and Drug Administration 98

Food and Drug Administration FDA Food Safety 98

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 94

Food and Drug Administration Medicine Safety FDA 94

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

Food and Drug Administration 59

Food and Drug Administration FDA Prescription Food 59

Pharmaceutical Technology

JUNE 15, 2023

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

Food and Drug Administration 52

Food and Drug Administration Side effects Recruitment 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

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

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

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

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

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 85

FDA Food and Drug Administration Food Leads 85

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 Safety Patients 98

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

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 90

FDA Food and Drug Administration Food Patients 90

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. Rigel Pharmaceuticals, Inc.

FDA 79

FDA Food and Drug Administration Food Patients 79

Pharmaceutical Technology

JULY 19, 2022

The application is based on the Phase III ADVANCE and PROGRESS clinical trial analysing the safety, efficacy and tolerability of atogepant in adult patients with episodic migraine and chronic migraine, respectively. Constipation and nausea were reported to the most common adverse events.

Marketing 52

Marketing Food and Drug Administration Safety Food 52

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

NOVEMBER 20, 2022

The occurrence of Grade 3 or higher events were found to be comparatively low. In June this year, the company filed a Supplement to a New Drug Submission with the regulatory agency for the vaccine usage as a primary series in adolescents aged 12 to 17 years.

Food and Drug Administration 59

Food and Drug Administration Food Safety Pharmaceutical 59

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

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

Pharmaceutical Technology

SEPTEMBER 19, 2022

Additionally, no new safety events linked to the combination treatment were reported versus nivolumab monotherapy. The latest development comes after the company received the US Food and Drug Administration approval for Sotyktu (deucravacitinib) for treating adults with moderate-to-severe plaque psoriasis.

Food and Drug Administration 52

Food and Drug Administration Food Safety Medical 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

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 84

Medical Food and Drug Administration Pharmacology Medicine 84

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. Thus, the biosimilar presented a similar efficacy to the reference product.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Insurance 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

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. cited 2024Mar].

Food and Drug Administration 93

Food and Drug Administration Leads Patients Side effects 93

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. cited 2024Mar].

Food and Drug Administration 92

Food and Drug Administration Leads Patients Side effects 92

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

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. with each event being common to focal liver therapies and not specific to histotripsy.

FDA 52

FDA Food and Drug Administration Physicians Safety 52

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

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). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval.

FDA 52

FDA Food and Drug Administration Medical Patients 52

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.

Marketing 96

Marketing FDA Food and Drug Administration Specialization 96

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 96

Safety Food and Drug Administration Prospecting Food 96

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. Significant adverse events include corneal edema, vision-impairing corneal edema, corneal transplant, and decrease in visual acuity.

Food and Drug Administration 52

Food and Drug Administration Recruitment FDA Patients 52

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.

FDA 89

FDA Food and Drug Administration Manufacturing Product sample 89