European Pharmaceutical Review

JANUARY 13, 2023

AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use auto-injector (AI) pen for severe asthma patients over 12 years. Trial results on the biologic for severe asthma . Regulatory decisions for Tezspire.

Food and Drug Administration 98

Food and Drug Administration Medicine FDA Physicians 98

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

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. The company stated that its findings support the potential for a safe, flexible, effective and convenient oral treatment option for PKU.

Food and Drug Administration 104

Food and Drug Administration FDA Engineering Medicine 104

Pharmaceutical Technology

MARCH 8, 2023

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The company develops innovative oncology drugs with a focus on paediatric and orphan cancers.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

European Pharmaceutical Review

SEPTEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. The biologic is approved for intravenous (IV) and subcutaneous (SC) administration.

Food and Drug Administration 104

Food and Drug Administration FDA Physicians Food 104

Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Food 98

Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). It significantly impacts patients’ lives, causing loss of mobility, progressive muscle wasting and neuropathic pain.

Food and Drug Administration 98

Food and Drug Administration FDA Food Manufacturing 98

Pharmaceutical Technology

APRIL 23, 2024

The US Food and Drug Administration (FDA) has granted approval for ImmunityBio's ANKTIVA, plus Bacillus Calmette-Guérin (BCG), for treating patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

Food and Drug Administration 52

Food and Drug Administration FDA Food Patients 52

European Pharmaceutical Review

MAY 7, 2024

A novel intravesical targeted drug delivery system for patients with bladder cancer has demonstrated positive data in updated results from a Phase I trial. The treatment is being evaluated in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations.

Food and Drug Administration 97

Food and Drug Administration Patients Food Safety 97

European Pharmaceutical Review

OCTOBER 17, 2024

This decision was granted a couple of weeks following approval by the US and Drug Administration (FDA). These factors may increase the likelihood that patients and caregivers carry it regularly. What are the main advantages of EURneffy over similar treatments? Casale TB, Ellis AK, Nowak-Wegrzyn A, et al. Oppenheimer J.

Food and Drug Administration 121

Food and Drug Administration Medicine Consulting Food 121

European Pharmaceutical Review

FEBRUARY 22, 2024

A report by Towards Healthcare has forecasted that the advanced drug delivery market will value $375.86 The year 2023 was “significant” for the progress of advanced drug delivery systems, the author reflected. A key innovation method is the oral route of administration. billion by 2033. Last year, with a size of $234.84

Food and Drug Administration 98

Food and Drug Administration Marketing Healthcare Healthcare 98

European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.

Food and Drug Administration 126

Food and Drug Administration Medicine FDA Food 126

European Pharmaceutical Review

AUGUST 2, 2024

For the first time in over a decade, there is a new treatment option for patients with synovial sarcoma, a rare soft tissue cancer. The US Food and Drug Administration (FDA) has granted accelerated approval for the cell therapy TECELRA ® (afamitresgene autoleucel) to treat adults with unresectable or metastatic forms of the disease.

Engineering 98

Engineering FDA Food and Drug Administration Food 98

European Pharmaceutical Review

MAY 17, 2024

The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle), a bispecific T-cell engager, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). FDA’s approval of Imdelltra was based on results from the Phase II DeLLphi-301 clinical trial.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica. severe itch) in each group.

Food and Drug Administration 97

Food and Drug Administration FDA Side effects Medicine 97

Pharmaceutical Technology

SEPTEMBER 21, 2023

On 15 September 2023, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s (GSK’s) Janus kinase (JAK) inhibitor, Ojjaara (momelotinib), for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia.

Food and Drug Administration 52

Food and Drug Administration FDA Food Patients 52

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). The findings showed that Miebo met its primary clinical sign and patient-reported symptom endpoint.

Food and Drug Administration 133

Food and Drug Administration FDA Prescription Food 133

European Pharmaceutical Review

OCTOBER 25, 2023

The US Food and Drug Administration (FDA) has approved a new therapy for adults with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH1) mutation, a rare type of blood cancer. The observed complete remission or partial remission rate in this patient group was 39 percent.

Food and Drug Administration 105

Food and Drug Administration FDA Food Pharmaceutical 105

European Pharmaceutical Review

OCTOBER 18, 2023

The US Food and Drug Administration (FDA) has approved XPHOZAH ® (tenapanor), the first and only phosphate absorption inhibitor. Overall, the data showed that XPHOZAH significantly reduced elevated serum phosphorus in patients receiving maintenance hemodialysis.

Food and Drug Administration 119

Food and Drug Administration FDA Food Patients 119

Pharmaceutical Technology

APRIL 18, 2023

IntelGenx Corp announced that the US Food and Drug Administration (FDA) has approved the company’s Rizafilm VersaFilm new drug application (NDA) for the treatment of acute migraine. It dissolves rapidly releasing the active ingredient in the mouth, meaning there is no requirement for the patient to swallow a pill.

Food and Drug Administration 98

Food and Drug Administration FDA Food Marketing 98

Pharmaceutical Technology

APRIL 24, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. The company noted that the ODD from the FDA is not an approval for the use of XORLO, a formulation of oxypurinol.

Food and Drug Administration 52

Food and Drug Administration FDA Pharmacology Food 52

European Pharmaceutical Review

JANUARY 17, 2024

The small molecule heart failure drug acoramidis has potential in slowing or stopping the progression of transthyretin amyloid cardiomyopathy (ATTR-CM), according to study data published in the New England Journal of Medicine. The drug was also shown to lower cardiac congestion.

Food and Drug Administration 97

Food and Drug Administration FDA Food Competition 97

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.

Food and Drug Administration 105

Food and Drug Administration FDA Food Patients 105

Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. The new drug application (NDA) included data from the Phase III FRESCO-2 and FRESCO trials conducted in China.

Food and Drug Administration 105

Food and Drug Administration FDA Prescription Food 105

Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

Food and Drug Administration 105

Food and Drug Administration Pharmaceutical FDA Food 105

Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

Food and Drug Administration 98

Food and Drug Administration FDA Medical science Food 98

European Pharmaceutical Review

AUGUST 18, 2022

The US Food and Drug Administration (FDA) has approved bluebird bio’s Zynteglo (betibeglogene autotemcel; beti-cel), the first cell-based gene therapy for the treatment of adult and paediatric patients with beta-thalassemia who require regular red blood cell transfusions. .

Food and Drug Administration 98

Food and Drug Administration Patients FDA Food 98

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 105

Food and Drug Administration FDA Safety Food 105

Pharmaceutical Technology

JULY 8, 2022

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

Pharmaceutical Technology

APRIL 5, 2023

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to InflaRx’s Gohibic (vilobelimab) to treat critically ill hospitalised Covid-19 adult patients. It is a first-in-class monoclonal anti-human complement factor C5a antibody.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising.

Food and Drug Administration 97

Food and Drug Administration FDA Safety Food 97

European Pharmaceutical Review

JANUARY 16, 2023

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults.

Food and Drug Administration 122

Food and Drug Administration FDA Competition Pharma 122

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. Earlier in 2023, the US FDA granted its fast track designation to capivasertib for the same indication.

Food and Drug Administration 98

Food and Drug Administration FDA Food Competition 98

European Pharmaceutical Review

DECEMBER 18, 2023

After eight weeks of treatment, patients’ depression severity scores dropped by an average of 19.1 A second study led by Yvan Beaussant from the Dana-Farber Cancer Institute that gathered input from patients in the trial during exit interviews. Participants involved in the trial had moderate to severe depression scores at baseline.

Food and Drug Administration 116

Food and Drug Administration Patients Side effects Safety 116

European Pharmaceutical Review

JANUARY 20, 2023

The US Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. Lilly confirmed that the Phase III trial included more than 100 patients treated with donanemab.

FDA 98

FDA Food and Drug Administration Safety Medicine 98

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.” US sales of Stelara totalled $6.4

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Safety 98

Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has accepted and granted priority review to Takeda ’s biologics licence application (BLA) for its enzyme replacement therapy, TAK-755, to treat congenital thrombotic thrombocytopenic purpura (cTTP).

Food and Drug Administration 97

Food and Drug Administration FDA Food Patients 97