The Pharma Data

OCTOBER 22, 2020

FDA Approves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.

FDA Approval 52

FDA Approval Treatment FDA Hospitals 52

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.

FDA Approval 52

FDA Approval FDA Treatment Small Molecule 52

Drug Discovery World

SEPTEMBER 16, 2022

A slightly quieter week for news in light of national events in the UK, but the vital work of the international drug discovery community goes on and new discoveries are being made all the time. . Trial sheds light on combined treatment for colorectal cancer . FDA approves new first-line therapy for plaque psoriasis .

FDA Approval 130

FDA Approval Drugs FDA Clinical Trials 130

Drug Discovery World

NOVEMBER 14, 2023

“The FDA remains deeply committed in our efforts to help facilitate the development and approval of safe and effective therapies for patients with rare diseases,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. Without treatment, cTTP is ultimately fatal.

Therapies 130

Therapies FDA Approval Protein Production FDA 130

The Pharma Data

FEBRUARY 24, 2022

Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction.

FDA Approval 52

FDA Approval FDA Treatment Hospitals 52

Drug Discovery World

FEBRUARY 3, 2023

Drugs for lung cancer, lymphoma and breast cancer have received regulatory approvals, an investment boost will allow the development of a novel approach to treating tumours, and a new global commission will seek to improve access to personalised therapies.

FDA Approval 130

FDA Approval Drugs Therapies Treatment 130

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. It was developed with Genmab.

FDA Approval 52

FDA Approval FDA Clinical Trials Doctors 52

The Pharma Data

APRIL 20, 2023

FDA approves Roche’s Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. While many patients are responsive to initial treatment, as many as four in 10 people with DLBCL do not respond or relapse.

FDA Approval 40

FDA Approval FDA Treatment International 40

Drug Discovery World

APRIL 27, 2023

Biotechnology company Tiziana Life Sciences is initiating a programme to develop intranasal foralumab for the treatment or prevention of type 1 diabetes. With the FDA approval of the humanised anti-CD3 mAb TZIELD (teplizumab-mzwv injection) and then its subsequent announced acquisition of Provention Bio by Sanofi for $2.9

FDA Approval 130

FDA Approval Science International FDA 130

The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1] Comenzo, M.D.,

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

Drug Discovery World

SEPTEMBER 7, 2023

5 The Research to Accelerate Cures and Equity (RACE) for Children Act of 2017 authorised the Food and Drug Administration (FDA) to require paediatric clinical trials for new oncology drugs with relevant molecular targets and has a had a positive impact on the number of drugs approved in paediatric indications.

Clinical Trials 147

Clinical Trials Trials Drugs DNA 147

The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. in March, 2021.

FDA Approval 52

FDA Approval FDA Pharmaceutical Companies Therapies 52

The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization. KENILWORTH, N.J.–(BUSINESS

FDA Approval 52

FDA Approval FDA Hospitals Treatment 52

Drug Discovery World

JULY 2, 2024

An internal study performed recently, highlighted how Basel is outstanding in scientific collaboration with industry, measured via joint publications and at the same time how the local industry excels globally in the number of patents filed.” References [link] [link]. p1) appeared first on Drug Discovery World (DDW).

Science 147

Science Drugs Clinical Trials Licensing 147

The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. The sBLA submission is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. A decision on U.S.

Treatment 52

Treatment FDA Approval Clinical Trials FDA 52

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Food and Drug Administration (FDA) has approved Zokinvy (lonafarnib) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL). .

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019. Drug Enforcement Administration.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceutical Companies 52

The Pharma Data

MAY 18, 2021

VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the anti-PD1 immunotherapy JEMPERLI ( dostarlimab-gxly ). 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

Drug Discovery World

AUGUST 30, 2022

A new study has found that the antiviral tecovirimat (TPOXX) appears to be safe and effective for the treatment of monkeypox symptoms and skin lesions. TPOXX is an FDA-approved antiviral drug for the treatment of smallpox. Context and treatment.

Therapies 130

Therapies FDA Approval Vaccine Treatment 130

Drug Discovery World

MARCH 16, 2023

With a maturing clinical pipeline, many FDA-approved treatments are on the horizon. Clarke currently serves as the Chair for the International Society for Cell and Gene Therapies Process Development & Manufacturing Committee. The post Can characterisation industrialise cell and gene therapy?

Therapies 130

Therapies FDA Approval Science Production 130

The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 1 Treatment-related Grade ?3

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] 1] It is taken by mouth. [1] Hz, 1 H), 4.62−4.75

FDA Approval 52

FDA Approval FDA Treatment International 52

Drug Discovery World

SEPTEMBER 14, 2023

In May 2023, Pfizer announced the FDA approval Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. As a result of these moves, William Pao, M.D.,

Vaccine 147

Vaccine FDA Approval Drugs Licensing 147

The Pharma Data

FEBRUARY 1, 2021

Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy ® ( peginterferon beta-1a ) for the treatment of relapsing forms of multiple sclerosis (MS). 2 Multiple Sclerosis International Federation. MS is an autoimmune disorder that affects more than 2.3

FDA Approval 40

FDA Approval FDA Clinical Trials Biosimilars 40

New Drug Approvals

SEPTEMBER 20, 2023

To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma Motixafortide , sold under the brand name Aphexda , is a medication used for the treatment of multiple myeloma. [1] 1] It is given by subcutaneous injection. [1]

FDA Approval 52

FDA Approval FDA International Clinical Trials 52

New Drug Approvals

DECEMBER 24, 2023

Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] 2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 1] Society and culture Names Eplontersen is the international nonproprietary name. [9] 7 March 2023.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

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 Clinical Trials Therapies 52

The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] 1] [9] [10] Names Etrasimod is the international nonproprietary name.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

MARCH 30, 2021

2] – The atogepant application demonstrates AbbVie’s longstanding commitment to providing multiple migraine treatment options, including BOTOX® (onabotulinumtoxinA), a preventive treatment for those with chronic migraine, and UBRELVY® (ubrogepant), an acute treatment for adults with migraine. .

Treatment 52

Treatment FDA Doctors FDA Approval 52

Drug Target Review

MAY 27, 2024

What role do ADCs play in Caris’ strategy for targeted cancer therapy, particularly in terms of patient-specific treatment plans? At a base-layer, Caris’ comprehensive molecular profiling that we perform for patients today can identify predictive biomarkers for current FDA-approved ADCs.

Clinical Trials 58

Clinical Trials Science Molecular Biology Bioinformatics 58

Drug Discovery World

MAY 9, 2023

Despite considerable progress in cancer drug development over the past few decades, there remains a chasm between the number of investigational new drug (IND) approvals and commercialised oncology drugs. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

Drug Development 130

Drug Development Animal Testing Clinical Trials Cell Based Assays 130

The Pharma Data

AUGUST 14, 2020

In other news, Genentech’s Evrysdi (risdiplam) has secured FDA approval for the treatment of spinal muscular atrophy and Bristol Myers Squibb has announced positive data from two Phase 3 clinical trials of its drug Opdivo. Genentech’s Evrysdi becomes first FDA-approved oral treatment for spinal muscular atrophy.

FDA Approval 52

FDA Approval Vaccine Clinical Trials FDA 52

Broad Institute

FEBRUARY 8, 2024

Researchers uncover genetic factors for severe Lassa fever By Allessandra DiCorato February 8, 2024 Breadcrumb Home Researchers uncover genetic factors for severe Lassa fever New findings from an international collaboration pave the way for studies of highly infectious diseases in Africa such as Ebola. Chan School of Public Health.

Research 82

Research Virus Hospitals FDA Approval 82

Drug Discovery World

AUGUST 3, 2023

For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

Research 52

Research FDA Approval Packaging FDA 52

Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. More targeted therapies may change which patients and cancers may benefit, since a given treatment may only impact very specific biomarkers and genetic profiles. This means study startup times can vary greatly.

Trials 52

Trials Clinical Trials FDA Approval Animal Testing 52