PharmExec

FEBRUARY 20, 2024

The FDA assigned the supplemental new drug application for Krazati (adagrasib) plus cetuximab in patients with locally advanced or metastatic colorectal cancer with a Prescription Drug User Fee Act goal date of June 21, 2024.

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European Pharmaceutical Review

JANUARY 8, 2024

Commercial manufacturing of Novartis’ radioligand therapy Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its largest and most advanced manufacturing facility for these treatments manufacturing in the world, has been approved the US Food and Drug Administration (FDA).

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Pharmaceutical Technology

OCTOBER 13, 2023

The Phase IIb SurVaxM vaccine study will enrol 265 patients and has an estimated completion date in Q2 2024.

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PM360

FEBRUARY 12, 2024

Created by The European Organization for Rare Diseases (EURORDIS) , this globally coordinated event brings together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers, and their families.

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Pharmacy Times

OCTOBER 17, 2023

The committee will help the FDA address issues related to digital health technologies, including artificial intelligence, virtual reality, cyber security, and patient-generated health data.

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European Pharmaceutical Review

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). The major depressive disorder treatment is expected to be available for patients in early 2024.

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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.

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PharmExec

FEBRUARY 20, 2024

The FDA set a Prescription Drug User Fee Act date during Q4 of 2024 for the biologics license application for datopotamab deruxtecan in patients with previously treated advanced nonsquamous non-small cell lung cancer.

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Pharmaceutical Technology

SEPTEMBER 22, 2023

A Phase I trial exploring the gene therapy in patients with alpha-1 antitrypsin deficiency is expected to start in Q1 2024.

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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. By 2024, doxorubicin is anticipated to have a market size of $1.38bn and is extensively utilised as a part of the standard of care in various types of cancers. .

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pharmaphorum

SEPTEMBER 30, 2022

Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. An oral version of edaravone was cleared this year.

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Legacy MEDSearch

MARCH 1, 2024

Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. physicians the opportunity to treat their patients with this novel device.” of balloon angioplasty patients and 17.9% of AGENT DCB patients. Are you hiring?

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Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has accepted Ipsen’s supplemental new drug application (sNDA) for the Onivyde regimen as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) patients. The regulator has set 13 February 2024 as a Prescription Drug User Fee Act goal date for the review of Ipsen’s sNDA.

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Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options. The company intends to launch the biosimilar in the US in July 2023.

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Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.

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European Pharmaceutical Review

APRIL 17, 2024

Roche’s twice-yearly, 10-minute subcutaneous injection of OCREVUS ® (ocrelizumab) has shown significant promise for patients with either with relapsing or primary progressive multiple sclerosis (RMS or PPMS). percent had no relapse) in patients through 48 weeks of the treatment. No new safety signals were identified for OCREVUS SC.

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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. SYFOVRE is approved for GA patients with or without subfoveal involvement and provides dosing flexibility via a dosing regimen of every 25 to 60 days.

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European Pharmaceutical Review

APRIL 16, 2024

Novartis has released new data from the first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with the rare kidney disease IgA nephropathy (IgAN). Fabhalta was given a positive opinion from the CHMP of the EMA in March 2024, according to Novartis.

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Pharmaceutical Technology

DECEMBER 8, 2023

NextPoint plans to kickstart the first-in-human Phase I clinical trial in early 2024, investigating NPX887 in patients with HHLA2-positive tumours.

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.”

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PharmExec

NOVEMBER 30, 2023

Supplemental new drug application for roflumilast cream 0.15% to treat atopic dermatitis in patients 6 years of age and older was assigned a Prescription Drug User Fee Act target action date of July 07, 2024.

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Legacy MEDSearch

OCTOBER 10, 2023

Hammerdesis allows surgeons to correct hammertoe deformities and degenerative issues in patients by simply affixing a distinctively designed implant on the patient’s toe joint. Dr. David Murphy, DPM FACFAS remarked, “ Hammerdesis provides patients with a more reliable, and a more consistent option to fix hammertoe issues.

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pharmaphorum

SEPTEMBER 29, 2022

A digital patient monitoring tool developed by UK company CyberLiver has been given a breakthrough designation by the FDA for out-of-hospital management of patients with cirrhosis at risk of complications. The post Digital tool cuts hospital readmissions in cirrhosis patients appeared first on.

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European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. There were 381 Parkinson’s patients enrolled in the trial. and Joan A.

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PM360

FEBRUARY 8, 2024

SYLVANT Can Open the Door SYLVANT is the only FDA-approved therapy for idiopathic multicentric Castleman disease (iMCD) that targets the underlying cytokine storm and can help deliver sustained symptomatic relief and durable tumor response. iMCD can present with a wide range of symptoms.

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Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ 505(b)(2) new drug application (NDA) for a ready-to-use oncology injectable, PEMRYDI RTU. With a J-code from the Centers for Medicare & Medicaid Services, PEMRYDI RTU is expected to be launched in the first quarter of 2024.

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Pharmaceutical Technology

OCTOBER 12, 2022

Novo Nordisk has recently completed its six-part ONWARDS Phase III trial, as ONWARDS 5 reached its primary endpoint with Icodec demonstrating non-inferiority in reducing hemoglobin A1C (HbA1c) in patients with type 2 diabetes (T2D) at week 52 in comparison to once-daily basal insulin analogs. Patients had an overall baseline HbA1c of 8.9%

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Pharmaceutical Technology

APRIL 21, 2023

On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). Anti-interleukin therapies are generally prescribed as second-line or third-line treatment in UC patients who have failed a biological drug.

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European Pharmaceutical Review

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

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European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. The FDA’s approval of Ogsiveo is based on results from the Phase III DeFi clinical trial , which were published this year in the New England Journal of Medicine.

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European Pharmaceutical Review

DECEMBER 22, 2023

Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024. The drug is also undergoing trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease.

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European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. ng/day, compared to EMA which is 18 ng/day.

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European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). VYJUVEK (beremagene geperpavec-svdt) is authorised for DEB patients six months of age or older. DEB patients are also at risk of developing an aggressive form of skin cancer.

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European Pharmaceutical Review

DECEMBER 1, 2023

Regulatory approvals for the antibody-drug conjugate Antibody-drug conjugate ELAHERE was granted an accelerated marketing approval by the US Food and Drug Administration (FDA) in November 2022. The transaction is expected to close in the middle of 2024, subject to certain customary closing conditions.

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pharmaphorum

SEPTEMBER 15, 2022

The Massachusetts-based biotech said it a meeting with the FDA to discuss the programme has given it the confidence to press ahead with filing for approval of the RASP modulator in the US later this year. The post Aldeyra spies FDA filing ahead for dry eye drug reproxalap appeared first on. Image by StockSnap from Pixabay .

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European Pharmaceutical Review

DECEMBER 15, 2023

When the edited cells are transplanted back into the patients, BCL11A expression is reduced, increasing γ‑globin expression and production of foetal haemoglobin (HbF). This addresses absent haemoglobin A in patients with TDT and the aberrant haemoglobin S in patients with SCD, according to EMA.

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Legacy MEDSearch

AUGUST 21, 2023

It is the next generation of highly crosslinked polyethylene with vitamin E antioxidant that is intended to further our primary goal of providing immense benefits to our patients.” Global expansion will begin in 2024. The first products for Activit-E will launch in the beginning of Q3 2023 for select U.S. Are you hiring?

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