The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. This indication is approved under accelerated approval based on overall response rate and duration of response.

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The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. BUFFALO, N.Y.,

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The Pharma Data

SEPTEMBER 6, 2020

Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Gavreto is now the sixth FDA-approved medicine in Roche’s portfolio of treatments for lung cancer.

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The Pharma Data

FEBRUARY 25, 2022

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S. and Europe.

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The Pharma Data

FEBRUARY 24, 2022

– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction. – FDA approval marks a significant breakthrough for the approximately 3 million adults in the U.S.

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The Pharma Data

JANUARY 15, 2021

January 15, 2021 (HORSHAM, Pa.) – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. 2],[3] This indication is approved under accelerated approval and is based on the hematologic complete response rate (hemCR) measure. Approximately 4,500 people in the U.S. The most common adverse reactions (?20

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. About CNS Pharmaceuticals, Inc. SOURCE CNS Pharmaceuticals, Inc.

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The Pharma Data

MAY 18, 2021

Roche/GSK collaboration represents an important step towards a personalised healthcare strategy that can help identify patients who are most likely to benefit from a specific therapy. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. 24, 2020– Alnylam Pharmaceuticals, Inc. The FDA approval of Oxlumo represents a new path forward for many, providing an effective treatment option and a sense of hope.”. CAMBRIDGE, Mass.–(BUSINESS

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The Pharma Data

DECEMBER 1, 2020

VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need.

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The Pharma Data

JANUARY 7, 2021

VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need.

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The Pharma Data

MAY 6, 2022

The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. Source link: [link].

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Drug Target Review

JANUARY 8, 2024

Contrary to popular belief, ageing is not caused by just random wear and tear of our bodies over time but is instead caused by a discrete set of biological mechanisms that we now better understand and can target with therapies. a commercial stage pharmaceutical company. acquired by Teva Pharmaceuticals in 2014.

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PLOS: DNA Science

JANUARY 4, 2024

The end-of-year FDA approval of the first CRISPR-based therapy , for sickle cell disease, came a mere dozen years after Jennifer Doudna and Emmanuelle Charpentier introduced the technology. Sickle Cell Disease The CRISPR-based treatment for sickle cell disease is Casgevy , from CRISPR Therapeutics and Vertex Pharmaceuticals.

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The Pharma Data

OCTOBER 14, 2021

Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease (AD).

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The Pharma Data

APRIL 28, 2023

Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.

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The Pharma Data

NOVEMBER 23, 2021

Livtencity received Breakthrough Therapy and Priority Review designations for this indication. The FDA granted the approval of Livtencity to Takeda Pharmaceuticals Company Limited. Cleveland Clinic Cytomegalovirus (CMV) CMV is short for cytomegalovirus. It’s a type of herpes contagion.

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New Drug Approvals

SEPTEMBER 10, 2024

2] Vorasidenib was approved for medical use in the United States in August 2024. [2] 2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2]

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New Drug Approvals

SEPTEMBER 6, 2024

2 , 3 Lazertinib was first approved in South Korea on January 18, 2021, for the treatment of EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) with EGFR mutations. 1 It was approved by the FDA on August 19, 2024. 1 It was approved by the FDA on August 19, 2024. Food and Drug Administration (FDA).

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New Drug Approvals

SEPTEMBER 10, 2024

Deuruxolitinib C 17 H 18 N 6 , 314.422 Fda approved Leqselvi , 7/25/2024, To treat severe alopecia areata C-21543, CTP 543, CTP-543, CTP543 (3r)-3-(2,2,3,3,4,4,5,5-d8)cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile 1h-pyrazole-1-propanenitrile,beta.-(cyclopentyl-2,2,3,3,4,4,5,5-d8)-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,

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The Pharma Data

JUNE 22, 2023

Paulsen, who joined Ferring’s Board of Directors 1 in July 2021, played a leading role in securing the US approval of Adstiladrin ® (nadofaragene firadnovec-vncg) a first-in-class gene therapy offering a new approach to treating a severe form of BCG-unresponsive non-muscle invasive bladder cancer. Ad hoc announcement pursuant to Art.

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The Pharma Data

AUGUST 31, 2020

Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV – from appropriate counseling on disease differences to targeted therapy. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. Clin Infect Dis.

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The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly. About EMPEROR-Preserved.

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The Pharma Data

OCTOBER 9, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

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New Drug Approvals

SEPTEMBER 8, 2024

2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 1] Palopegteriparatide was approved for medical use in the European Union in November 2023, [2] and in the United States in August 2024. [1] mg/dL, a magnesium concentration ≥1.3

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the U.S. PLYMOUTH MEETING, Pa.

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The Pharma Data

JULY 12, 2021

The approval of finerenone offers a new path to protect patients from further kidney damage through addressing MR overactivation, a key driver of CKD progression, which is unaddressed by currently available therapies.”. Chronic kidney disease (CKD) is a common and potentially deadly condition that is generally underrecognized.

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Agency IQ

NOVEMBER 3, 2023

regulatory landscape for probiotics and other microbiome-based therapies Probiotics, a type of microbiome-based therapy containing live micro-organisms, are broadly available on drug store and grocery store shelves, but the regulatory classifications for products containing the same micro-organism can differ dramatically.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. NASDAQ: REGN) today announced that the antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19 , has received Emergency Use Authorization (EUA) from the U.S.

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The Pharma Data

JULY 8, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. is a leading global pharmaceutical company headquartered in Japan. Please see full Prescribing Information including Medication Guide.

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The Pharma Data

MARCH 5, 2021

Food and Drug Administration (FDA) approved Actemra ® /RoActemra ® (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a debilitating condition with limited treatment options. 1-3 SSc affects about 2.5

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New Drug Approvals

DECEMBER 24, 2023

1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] 2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] Ionis Pharmaceuticals. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. 7 March 2023.

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The Pharma Data

SEPTEMBER 11, 2020

In broader pharmaceutical news, Takeda has revealed it has agreed to divest its non-core portfolio of prescription therapies to Cheplapharm in exchange for an upfront payment of $562 million, while Mylan has announced an agreement to acquire the intellectual property and commercialisation rights to Aspen’s thrombosis business for €641.9

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Advarra

AUGUST 16, 2022

Food and Drug Administration (FDA) approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases. The FDA Since 1983. The Orphan Drug Act of 1983 was instrumental in changing the number of orphan drugs approved in the U.S. A Lasting Impact.

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The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.

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The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases.

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The Pharma Data

DECEMBER 16, 2020

–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical Co., 17, 2020 09:00 UTC.

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