The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. 27, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.

FDA Approval 52

FDA Approval FDA Clinical Trials Therapies 52

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.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

Codon

NOVEMBER 3, 2024

The experience showed me that new therapies are needed not only to meet the targets laid out by the End TB Strategy but also to prevent drug resistance from negating the effectiveness of current therapeutics. But now, researchers are increasingly using machine learning to speed up pharmaceutical breakthroughs.

Vaccine 96

Vaccine Trials Therapies Clinical Trials 96

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.

FDA Approval 52

FDA Approval Treatment FDA Therapies 52

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

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

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.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

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

FDA Approval 52

FDA Approval Treatment FDA RNA 52

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.

Pharmaceuticals 52

Pharmaceuticals FDA Approval FDA Therapies 52

Eye on FDA

AUGUST 4, 2021

Below is a chart that looks at 3 numbers – the number of AdComms; the number of new molecular entities approved each year, and the number of drugs that had breakthrough therapy designation. The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee.

FDA 122

FDA Clinical Pharmacology FDA Approval Therapies 122

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.

Pharmaceuticals 52

Pharmaceuticals FDA Approval Clinical Trials FDA 52

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.

FDA Approval 52

FDA Approval FDA Hospitals Clinical Trials 52

Drug Target Review

DECEMBER 5, 2024

Viral vectors have been crucial in transforming the gene therapy landscape due to their natural ability to infect cells. 1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2.

Therapies 52

Therapies Virus DNA Compliance 52

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.

FDA Approval 40

FDA Approval FDA DNA Therapies 40

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.

FDA Approval 52

FDA Approval FDA Virus Disease 52

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).

Therapies 52

Therapies Disease FDA Trials 52

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].

FDA Approval 52

FDA Approval Licensing Licensing FDA 52

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.

FDA Approval 52

FDA Approval Treatment FDA DNA 52

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.

Therapies 52

Therapies FDA Hospitals FDA Approval 52

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).

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

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.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

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

FDA Approval 52

FDA Approval Vaccine Clinical Trials FDA 52

Drug Target Review

JUNE 5, 2023

There is a high unmet medical need in this area because while other candidates have shown early signs of clinical activity, there is still a need for therapies with improved safety and efficacy profiles. Mesothelin (MSLN) is overexpressed in many cancer indications, including pancreatic, mesothelioma and ovarian.

Treatment 100

Treatment Pharmacokinetics Drugs Cell Biology 100

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.

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

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

FDA 52

FDA Disease FDA Approval Therapies 52

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.

FDA Approval 40

FDA Approval FDA Treatment Clinical Trials 40

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.

FDA Approval 52

FDA Approval DNA Therapies Clinical Trials 52

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]

FDA Approval 62

FDA Approval FDA Clinical Trials Trials 62

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.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

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.

Therapies 52

Therapies Hospitals Treatment FDA Approval 52

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.

FDA Approval 40

FDA Approval Treatment FDA Clinical Trials 40

The Pharma Data

OCTOBER 26, 2020

Kala Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved EYSUVIS for the short-term treatment of dry eye disease. . EYSUVIS is the first FDA-approved corticosteroid specifically for dry eye disease treatment. Roughly 16.4 million U.S.

Disease 52

Disease Treatment FDA FDA Approval 52

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.

Pharmaceuticals 40

Pharmaceuticals FDA Approval Science International 40

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.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. with Xolair since its initial approval in 2003. with Xolair since its initial approval in 2003. indications. In the U.S.,

FDA Approval 52

FDA Approval Clinical Development FDA Treatment 52

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Testing Therapies, Antivirals and Vaccines. It expects to expand to a broad range of additional tests in the future.

Vaccine 52

Vaccine FDA Approval Clinical Trials FDA 52

The Pharma Data

JANUARY 13, 2021

“Receiving Fast Track designation is an important acknowledgment of the results of our COVID-19 laboratory research,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. Alerts Sign-up for Innovation Pharmaceuticals email alerts is available at: [link]. Source link.

Clinical Trials 52

Clinical Trials Trials Treatment Pharmaceuticals 52

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.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62