Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.

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Food and Drug Administration Physicians Medical Prescription 111

Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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Food and Drug Administration Pharmacology Side effects Physicians 141

European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today? Prefilled syringes bring a range of benefits.

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Food and Drug Administration Manufacturing Pharma Patients 98

Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre is claimed to be the first and only therapy approved for GA.

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Food and Drug Administration FDA Physicians Food 98

European Pharmaceutical Review

JANUARY 19, 2023

The contribution will enable the programme to reach additional physicians and medical students, further expanding the initiative that aims to extend the reach of clinical trials in underserved patient populations in US communities. The Winn Award Program has so far trained 114 early-stage investigator physicians.

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Food and Drug Administration Physicians Medicine Food 98

Evolve Your Success

APRIL 23, 2025

Most other civilized countries the government actually negotiates with pharma, drugs, medical equipment and so forth and get a discount as a result of all of their patients. Sure, and I would say insurance is more important in the United States than it probably is anywhere else in the world. We in America we don’t do that.

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Medical sales Sales Medical Healthcare 130

Legacy MEDSearch

SEPTEMBER 12, 2022

a company that provides Ear, Nose and Throat (ENT) physicians with non-invasive solutions to treat chronic nasal conditions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of a next-generation RhinAer® stylus. Aerin Medical Inc., offices in California and Texas.

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Medical Patients FDA Physicians 98

European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). When the cilta-cel CAR protein binds to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells, Legend Biotech explained.

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Food and Drug Administration FDA Medicine Physicians 98

Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

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Food and Drug Administration FDA Medicine Pharmaceutical 98

European Pharmaceutical Review

DECEMBER 6, 2023

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). Novartis’ Factor B inhibitor, Fabhalta ® (iptacopan) provides comprehensive control of red blood cell (RBC) destruction, according to the company. percent for anti-C5.

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Food and Drug Administration Patients Physicians Food 108

Pharmaceutical Technology

AUGUST 8, 2022

The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences ’ Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis in pre-menopausal women.

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Food and Drug Administration FDA Management Physicians 75

Pharmaceutical Technology

APRIL 11, 2023

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

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Safety Food and Drug Administration FDA Side effects 59

European Pharmaceutical Review

AUGUST 30, 2022

The EC also endorsed the European Medicines Agency’s (EMA’s) recommendation for Roctavian to maintain orphan drug designation, thereby granting a 10-year period of market exclusivity. . BLA resubmissions are typically followed by a six-month review process.

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Food and Drug Administration Medicine Patients Physicians 98

pharmaphorum

JUNE 27, 2022

7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate. The AMCP backed bill (H.R. Then, of course, guidance is not law.

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Food and Drug Administration Medical Patients FDA 95

pharmaphorum

DECEMBER 9, 2022

This means that enrolment is now completed for the initial target or morphological cohort to form the basis of a Biological License Application (BLA) submission by the end of CY2023 to the US Food and Drug Administration (FDA).

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Food and Drug Administration Safety Biopharma Patients 98

Nixon Gwilt Law

JULY 12, 2024

The 2025 Medicare Physician Fee Schedule Proposed Rule (the “2025 Proposed Rule”) issued by the Centers for Medicare and Medicaid Services (or “CMS”) on July 10, 2024 contains a number of new policy proposals with significant implications for healthcare innovators. Stakeholders should consider submitting comments on this issue.

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Physicians Management Food and Drug Administration Healthcare 52

Legacy MEDSearch

JANUARY 3, 2023

Food and Drug Administration for its Respiratory Health point of care test. Visby Medical announced that it has received Emergency Use Authorization (EUA) from the U.S. However, PCR testing has not been widely adopted in outpatient settings in part, because of the expense required to adopt and maintain PCR instrumentation.

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Medical Food and Drug Administration FDA Recruitment 98

European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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Pharmaceutical Food and Drug Administration Medicine Patients 96

Legacy MEDSearch

NOVEMBER 9, 2022

Food and Drug Administration. The adoption of the Early Bird system is a testimony to physicians embracing the benefits of early bleed detection for their patients and practice.”. “We The Early Bird was launched in 2019 following a De Novo classification by the U.S. For more information, please visit www.saranas.com.

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Patients Food and Drug Administration Physicians Recruitment 98

Legacy MEDSearch

FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Hyperfine, Inc., The Swoop® system received initial U.S.

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Food and Drug Administration FDA Recruitment Medical 98

Pharmaceutical Technology

JANUARY 16, 2023

AstraZeneca has announced that its Tezspire (tezepelumab) received approv al from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the EU for self-administration in severe asthma patients aged 12 years and above.

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Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration.

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Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.

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Food and Drug Administration FDA Physicians Prescription 52

Legacy MEDSearch

MARCH 1, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., Chief Executive Officer of SpectraWAVE.

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Food and Drug Administration Physicians Recruitment Medical 97

Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

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Food and Drug Administration Physicians Competition FDA 59

Legacy MEDSearch

SEPTEMBER 16, 2022

Food and Drug Administration (FDA) has cleared its Tasso+ lancet as a Class II medical device. Healthcare systems and physicians will also be able to use the Tasso+ device with compatible collection tubes to make determinations on blood chemistries for their patients and expand care access. Tasso, Inc.,

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Medical FDA Food and Drug Administration Recruitment 97

pharmaphorum

OCTOBER 3, 2022

This typically sees higher-priced drugs, even in oncology, being sidelined in favour of biosimilars, off-patent branded drugs, or locally manufactured alternatives, unless manufacturers offer significant discounting to gain access to national essential medicines lists. However, even then, challenges could remain.

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pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Kyle advises investors, academic medical centres, physician practices, and consultants on a range of business, legal, and regulatory issues affecting the telemedicine industry. If so, developers must develop and execute on a regulatory strategy.

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Food and Drug Administration FDA Medical Food 104

Legacy MEDSearch

MARCH 15, 2023

In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

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Food and Drug Administration FDA Recruitment Physicians 97

European Pharmaceutical Review

JULY 13, 2023

In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

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Medical Food and Drug Administration Pharmacology Medicine 98

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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Food and Drug Administration FDA Medical Food 105

Pharmaceutical Technology

JULY 12, 2022

The order is contingent on the vaccine obtaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) as well as the Centers for Disease Control and Prevention (CDC) recommendation. million doses of the company’s Covid-19 vaccine, NVX-CoV2373, in the initial stage.

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Food and Drug Administration FDA Government Physicians 64

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

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Side effects Food and Drug Administration Safety Physicians 64

Legacy MEDSearch

JUNE 17, 2022

Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest addition to the company’s LOBO ® Vascular Occlusion System. Okami Medical Inc., Okami Medical – LOBO Vascular Occlusion System. ” About Okami Medical, Inc.

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Medical FDA Food and Drug Administration Recruitment 90

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house.

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Manufacturing Food and Drug Administration Patients Pharma 104

Legacy MEDSearch

MARCH 27, 2023

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. The LCD screen on the handle of the device allows the physician to visualize internal patient anatomy in line with instrument insertion. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device.

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Food and Drug Administration FDA Recruitment Physicians 52