The Pharma Data

JANUARY 17, 2021

18 , 2021 /PRNewswire/ — Hanmi Pharmaceutical Co., In particular, two new drugs developed by Hanmi Pharmaceutical Co., are expected to be approved by the U.S. . In particular, two new drugs developed by Hanmi Pharmaceutical Co., are expected to be approved by the U.S.

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Agency IQ

JANUARY 12, 2024

After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. Fill out the form to read the full article.

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Drug Discovery World

FEBRUARY 22, 2024

Out of the top 20 players, nine companies indicated positive growth in stock market value, with four companies – Lilly (59.2%), Novo Nordisk (51.5%), Vertex Pharmaceuticals (41.4%) and Regeneron Pharmaceuticals (21.8%) – reporting more than 20% YoY growth in market capitalisation. billion for 2023.

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Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. References Iversen et al., Front Pharmacol.,

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The Pharma Data

MARCH 22, 2023

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira ® * (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock.

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Drug Discovery World

JULY 31, 2023

Biogen has revealed an agreement to acquire Reata Pharmaceuticals for approximately $7.3 The new acquisition will give Biogen rights to Reata’s portfolio of products for neurological diseases, including the FDA-approved Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s ataxia (FA) in the United States.

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The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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Drug Discovery World

MAY 1, 2024

She says: “Adoptive T-cell therapy (ACT), particularly T-cell-based transplantation, is attracting increasing attention and is advancing rapidly since the FDA approval of CAR-T therapy for the treatment of relapsed/refractory acute lymphoblastic leukaemia and B-cell malignancies.

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Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. If your go-to-market strategy requires FDA approval, it may also require a prior approval supplement. Go-to-market Strategy.

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Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. Related Articles: Danyelza (naxitamab-gqgk) FDA Approval History. NEW YORK, Nov. Source link.

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The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year,” commented John Climaco , CEO of CNS Pharmaceuticals. About CNS Pharmaceuticals, Inc.

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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.

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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. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

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The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.

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Drug Discovery World

FEBRUARY 15, 2024

Cessation Therapeutics is a pharmaceutical company that is developing antibody therapies to prevent and reverse overdosing caused by fentanyl. As it stands, there are no FDA-approved products designed to prevent a fentanyl overdose. Yes, we believe that industry, government, and healthcare providers can all help in this area.

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Drug Discovery World

AUGUST 9, 2023

Read more: BioIVT acquires biospecimens provider PrecisionMed Biogen acquires Reata During a period of upheaval for the company, Biogen revealed its purchase of Reata Pharmaceuticals for approximately $7.3

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Drug Discovery World

SEPTEMBER 13, 2022

Ayala Pharmaceuticals has revealed positive interim results from its ongoing RINGSIDE Pivotal Phase II and III clinical trial into gamma-secretase inhibitor AL102 in desmoid tumours. We are very encouraged by the results presented by Ayala and the opportunity that AL102 holds in improving outcomes for patients with this rare condition.”.

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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. Learn more at www.janssen.com.

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The Pharma Data

SEPTEMBER 6, 2020

Basel, 7 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

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Drug Discovery World

MARCH 7, 2023

Dr Thomas has a background in biochemistry research at Leicester, Cambridge, and Glaxo, after which she has had 25 years of pharmaceutical drug discovery and development experience from large Pharma (GSK) and SMEs. I owe so much to Franklin and many others.” See her interview with Megan Thomas at the Avacta Group Open Day.

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Drug Discovery World

JUNE 1, 2023

A Nature publication confirmed that there are currently 12 FDA-approved ADCs on the market, and nine of these secured FDA approval in the past six years 2. DDW’s Megan Thomas explores three trends in the market.

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The Pharma Data

MAY 18, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. FDA approval of the VENTANA MMR RxDx Panel provides clinicians with access to a fully automated, easy-to-use MMR test to identify patients who are eligible for therapy with JEMPERLI.

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Drug Discovery World

SEPTEMBER 16, 2022

FDA approves new first-line therapy for plaque psoriasis . The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s allosteric tyrosine kinase 2 inhibitor Sotyktu (deucravacitinib) for the treatment of adults with moderate-to-severe plaque psoriasis. .

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Drug Discovery World

NOVEMBER 29, 2023

The simulator could also be used by pharmaceutical companies to rapidly test multiple drug therapies and patient scenarios, increasing the speed and cost of drug development. The researchers expect their model will be ready for use in a clinical setting within five years.

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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. ABOUT AURINIA.

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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. ABOUT AURINIA.

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The Pharma Data

MARCH 15, 2022

The FDA regularly takes steps to help guide industry through the development process for generic drug products, including combination products, such as MDIs, that consist of a drug and a device. The FDA granted approval of this generic budesonide and formoterol fumarate dihydrate inhalation aerosol to Mylan Pharmaceuticals, Inc.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS –(BUSINESS WIRE)– Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Source link.

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Drug Discovery World

MAY 3, 2023

Vicore Pharma, a Swedish clinical-stage pharmaceutical company unlocking the potential of angiotensin II type 2 receptor agonists (ATRAGs), has dosed its first patient with C21 in a clinical study of endothelial dysfunction. Vicore Pharma states that results from the trial are expected in Q4, 2023.

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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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Drug Discovery World

SEPTEMBER 14, 2023

As the second quarter of 2023 draws to a close, DDW’s Megan Thomas reviews key updates and results from three top pharmaceutical companies. In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America. billion, a decrease of $15.0

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The Pharma Data

SEPTEMBER 1, 2021

Approval is backed by nearly two decades of proven efficacy and safety of Janssen’s long-acting injectable portfolio of schizophrenia medicines. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months.

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The Pharma Data

JULY 29, 2021

The FDA released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products. The FDA granted approval of Semglee (insulin glargine-yfgn) to Mylan Pharmaceuticals Inc. Source link: [link].

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Drug Discovery World

JUNE 14, 2023

An FDA approval for Pfizer’s Abrysvo respiratory syncytial virus (RSV) vaccine is likely to threaten GSK’s current hold on the market, according to GlobalData. As an RNA virus, RSV is capable of rapid mutation to escape attack by new pharmaceuticals.

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