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.

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Pharmaceutical Technology

JUNE 21, 2023

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 We are dedicated to addressing heart disease, the leading cause of death, by ensuring all patients have access to LODOCO.” mg tablet) to treat cardiovascular disease.

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European Pharmaceutical Review

JANUARY 3, 2023

A marketing authorisation application (MAA) has been submitted by The Janssen Pharmaceutical Companies of Johnson & Johnson to the European Medicines Agency (EMA) for approval of talquetamab, a bispecific t-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

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World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. ” So, are we supposed to believe that better images in DTC ads lead to patients asking for an Rx? ” Uh…no.

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World of DTC Marketing

MARCH 23, 2022

Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012.

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Pharmaceutical Technology

JUNE 12, 2023

Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon. Shares in Futura Medical rose following the FDA nod – opening 28% higher than the previous day’s (June 9) close.

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Pharmaceutical Technology

JULY 12, 2022

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands. The total market for cell therapies in oncology is projected to exceed $37bn worldwide by 2028.

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Leads Food and Drug Administration Marketing Sales 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 marketing authorisation application (MAA) is under review by the European Medicines Agency (EMA) with a regulatory decision expected in early 2024.

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Pharmaceutical Technology

MARCH 27, 2023

Food and Drug Administration (FDA) for Lifileucel. The BLA submission for lifileucel, a leading drug candidate of the company, is a step toward in making TIL therapy an option for patients who have progressed following prior treatments. “Our Iovance is pursuing accelerated approval in this indication.

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Legacy MEDSearch

NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. Trauma/ER: The BodyTom 64’s unique combination of internal lead shielding and battery operation allows any standard trauma bay to be transformed into an advanced CT imaging suite. About NeuroLogica.

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FDA Food and Drug Administration Electronics Recruitment 92

World of DTC Marketing

FEBRUARY 1, 2022

According to STAT News “after a double-digit decline in 2021, the sector has fallen another 20% in the new year, erasing billions in value and leading even the most seasoned investors to question whether biotech has further to fall. Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen.

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Legacy MEDSearch

DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today.

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FDA Food and Drug Administration Recruitment Medical 95

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. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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Pharmaceutical Technology

MAY 25, 2023

Pushing back an initial deadline, the US Food and Drug Administration (FDA) has proposed a new regulatory action date of 22 June, by which time the agency will assess the logistics of a possible approval for Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) gene therapy.

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Pharmaceutical Technology

MARCH 27, 2023

The US Food and Drug Administration (FDA) has granted approval for Pharming Group’s Joenja (leniolisib) to treat adult and paediatric patients aged 12 years and above with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS). Joenja is an oral, selective small molecule PI3Kẟ inhibitor.

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European Pharmaceutical Review

FEBRUARY 2, 2024

Biogen’s decision A strategic review of the company’s R&D work evaluated the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval, Biogen explained.

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Food and Drug Administration FDA Food Marketing 70

Legacy MEDSearch

NOVEMBER 1, 2022

Food & Drug Administration (FDA) for its smaller-diameter CurvaFix® IM Implant indicated for fixation of fractures of the pelvis. Often, conservative treatment leads to lengthy hospitalizations, high nursing home admittance, and a high one-year mortality rate. Food & Drug Administration (FDA).

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Food and Drug Administration FDA Recruitment Food 98

European Pharmaceutical Review

MARCH 8, 2023

Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and Drug Administration (FDA). Click here to read EPR’s previous ‘ Women Inspiring Pharma’ series.

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Legacy MEDSearch

JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc., Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 98

Legacy MEDSearch

OCTOBER 25, 2022

Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System. “We are pleased that the FDA has recognized the therapeutic potential of the EndoStim System as a new treatment in development for drug refractory GERD,” said Eric Goorno, Chief Executive Officer of EndoStim. .

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Food and Drug Administration FDA Recruitment Side effects 98

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. Legacy systems for breathing assistance are causing multiple complications leading to physical damage, infection and possible death. ” About Inspira Technologies OXY BHN Ltd. Are you hiring?

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FDA Food and Drug Administration Recruitment Medical 52

Pharmaceutical Technology

OCTOBER 12, 2022

This successful outcome for insulin icodec increases the likelihood of achieving Food and Drug Administration (FDA) approval next year, which will establish Novo Nordisk’s dominance in the basal insulin market with the first once-weekly basal insulin therapy.

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pharmaphorum

JANUARY 23, 2023

Beijing-based pharma, BeiGene’s Brukinsa (zanubrutinib) has been approved by the US Food and Drug Administration (FDA) for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The post BeiGene’s Brukinsa FDA approved for CLL/SLL appeared first on.

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FDA Food and Drug Administration Food Patients 52

Pharmaceutical Technology

JULY 28, 2022

The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM. The frequency of administration associated with a therapy is a critical factor that companies in this space focus on to fine-tune their chances of success in the wAMD market.

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Legacy MEDSearch

AUGUST 25, 2023

Paragonix Technologies , a leading organ transplant company, received US Food and Drug Administration (“FDA”) clearance for its next-generation donor lung preservation system, BAROguard. The FDA clearance of BAROguard is a major step in providing transplant teams with leading technology to enhance organ transplantation outcomes.”

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Pharmaceutical Technology

MARCH 30, 2023

The US FDA has revealed its detailed budget proposal for FY2024, which would require pharma companies to name their active pharmaceutical ingredient (API) suppliers, restart President Biden’s Cancer Moonshot, inject cash into amyotrophic lateral sclerosis (ALS) research, and enforce stricter rules around manufacturing, recalls, and shortages.

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Pharmaceutical Technology

SEPTEMBER 22, 2022

Avrobio has received rare pediatric disease designation from the US Food and Drug Administration (FDA) for its investigational gene therapy, AVR-RD-04, designed to treat cystinosis. It leads to progressive damage to various organs, including early, acute kidney disease advancing to end-stage kidney disease.

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World of DTC Marketing

SEPTEMBER 7, 2022

They relied so much on a new drug that they tried to market a product with bad science behind it. Rather than investing more in R&D, most pharma companies feel its more cost-effective to buy small biotech companies developing unique molecules that can find a market niche. oncology therapeutics market has reached $71 billion.

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Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. Hyperfine, Inc.,

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Food and Drug Administration FDA Recruitment Food 98

European Pharmaceutical Review

JUNE 13, 2024

Tell us about Ocugen’s lead programme, OCU400. In April 2024, Ocugen received US Food and Drug Administration (FDA) clearance to initiate the Phase III liMeliGhT clinical trial for OCU400 for retinitis pigmentosa. In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation.

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Legacy MEDSearch

AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. Muratoglu invented the first crosslinked polyethylene, and the first of multiple generations of vitamin E, antioxidant polyethylene for leading orthopaedic companies. “We Headquartered in Gainesville, Fla.,

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European Pharmaceutical Review

AUGUST 18, 2023

The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat geographic atrophy (GA). Clinical evidence that supported the marketing authorisation application The MAA is based on the GATHER1 and GATHER2 Phase III clinical trials.

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Legacy MEDSearch

JULY 18, 2023

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). The ReddyPort elbow safely delivered 45,000 compliant oral care sessions to patients under FDA Emergency Use Authorization (EUA). Are you hiring?

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FDA Food and Drug Administration Recruitment Patients 52

Pharmaceutical Technology

SEPTEMBER 7, 2022

The diabetic macular oedema (DME) market is anticipated to reach values of $11.1bn in 2031 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan).

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Food and Drug Administration Marketing Food Patients 52

Legacy MEDSearch

AUGUST 17, 2023

Welldoc ® , a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar ®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.

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FDA Food and Drug Administration Recruitment Management 52

Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension. Are you hiring?

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Medical Food and Drug Administration FDA Recruitment 52