The Pharma Data

JUNE 22, 2023

FDA approval Pfizer (NYSE: PFE) announced that the U.S. With today’s FDA approval of TALZENNA plus XTANDI, we are proud to be able to offer this potentially practice-changing treatment to patients and add to their options in managing this aggressive disease.” The final OS data is expected in 2024.

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The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. in 1-15 year olds and 98.7-100%

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Drug Discovery World

OCTOBER 10, 2023

The dosing was completed with no serious adverse events or other adverse events that may preclude continued dosing. The completed Cohorts 4 and 5 evaluated two 12mg doses of CYB003, and recruitment is underway to commence dosing for Cohort 6, the final cohort in the Phase II portion of the study.

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The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

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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

JUNE 26, 2021

Pradaxa is the first FDA-approved blood thinning medication that children can take by mouth; the only other approved blood thinning medication for children is given by injection. Pradaxa was originally approved in 2010 to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. By some estimates, more than half of these patients are rehospitalized within a month of discharge due to a worsening event and approximately one in five die within two years,” said Dr. Paul W. KENILWORTH, N.J.–(BUSINESS 0.98; p=0.019).

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The Pharma Data

OCTOBER 8, 2021

Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S. director of the FDA’s Center for Biologics Evaluation and Research.

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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.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

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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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Drug Discovery World

JUNE 27, 2024

A similar bispecific antibody, emicizumab, manufactured by Genentech, was first granted Food and Drug Administration (FDA) approval for haemophilia A in 2017. This restores the body’s thrombin generation capacity, helping blood to clot.

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Drug Discovery World

AUGUST 24, 2023

The most common adverse event (AEs) observed in the study was cytokine release syndrome (77%, 1.5% An estimated 76.3% of patients maintained a response for at least nine months at the 0.8mg/kg and 0.4mg/kg doses, respectively. Grade 3 or 4).

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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. The safety profile was comparable for Polivy plus R-CHP versus R-CHOP, including rates of Grade 3-4 adverse events (AEs; 57.7%

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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. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity. Related Articles: Imcivree (setmelanotide) FDA Approval History.

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Drug Discovery World

AUGUST 10, 2023

Consistent with the previously reported Phase III ORCA-2 study, ORCA-3 showed a statistically significant benefit in helping people to quit smoking compared to placebo, with low rates of adverse events. MT: What do these results mean for escalating levels of vaping? JB: Nicotine dependency continues to be a prominent health issue worldwide.

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The Pharma Data

NOVEMBER 24, 2020

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

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The Pharma Data

MAY 5, 2021

A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm. The primary composite endpoint included reduction in kidney function, progression to kidney failure, or CV- or kidney-related death.

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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. . FDA approves new first-line therapy for plaque psoriasis . Trial sheds light on combined treatment for colorectal cancer .

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Drug Discovery World

FEBRUARY 15, 2024

As it stands, there are no FDA-approved products designed to prevent a fentanyl overdose. There are very few treatments available to treat opioid use disorder (OUD) and we do believe the ones that are FDA approved should be made widely available to patients. As such, they have no intrinsic abuse potential.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. “For BASEL, Switzerland, Dec.

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approval. PALO ALTO, Calif.,

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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] 2] Mayo Clinic.

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Drug Discovery World

MAY 3, 2023

The study Vicore is conducting a randomised, double-blind, placebo-controlled, cross-over trial evaluating the effect of ATRAGs on endothelial dysfunction (reflecting blood vessel health) in patients with type-2-diabetes-mellitus (T2DM )1, a condition where endothelial dysfunction is central in the development of organ damage. The trial will (..)

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The Pharma Data

FEBRUARY 24, 2022

In diabetic patients, the most common adverse events were urinary tract infections and female fungal infections. The side effects in clinical studies with Jardiance for patients with heart failure were generally consistent with side effects for patients with diabetes.

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The Pharma Data

JULY 15, 2021

Merck Has Submitted These Data From KEYNOTE-522 to the US FDA for Review. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase 3 study KEYNOTE-522. 10) as determined by an FDA-approved test.

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ASPET

JUNE 27, 2024

Secondary VAS and pharmacokinetic (PK) endpoints and adverse events were assessed. Drug Liking and all other VAS outcomes were greatest for nabilone 3mg and 6mg, which is a currently FDA-approved medication. Three doses of lenabasum (20, 60, and 120mg) were compared to placebo, and nabilone (3 and 6mg).

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Drug Discovery World

MARCH 1, 2024

The trial compared Pepaxto with low-dose dexamethasone to pomalidomide with low-dose dexamethasone in patients with relapsed or refractory (resistant) multiple myeloma following two to four lines of prior therapy and in patients who were resistant to lenalidomide in the last line of therapy.

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The Pharma Data

SEPTEMBER 27, 2021

1 High levels of LDL-C starting at birth accelerate the event of atherosclerotic disorder , resulting in an overall increased risk of cardiovascular events, including attack and other vascular conditions, at an earlier age.2 HeFH is an inherited, genetic condition with a prevalence of 1 in 250 people worldwide.1

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Drug Discovery World

AUGUST 14, 2023

His research led to the HPV vaccine Gardasil, which gained FDA approval in 2006 and is now available in more than 120 countries with more than 100 million doses having been distributed around the world. In the wake of a global pandemic, Australia’s immediate focus is on vaccine manufacturing capacity expansion.

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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. The primary endpoint was the frequency of all adverse events, including serious adverse events.

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The Pharma Data

FEBRUARY 1, 2021

In clinical trials, the most common adverse events associated with Plegridy were injection site reactions and flu-like symptoms. A list of adverse events can be found in the full Plegridy product labeling for each country where it is approved. Related Articles: Plegridy (peginterferon beta-1a) FDA Approval History.

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The Pharma Data

MAY 6, 2022

The adverse event profile was generally consistent with other clinical safety data for the vaccine, with a favorable safety profile observed in individuals with at least 6 months of safety follow-up after the second dose.

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The Pharma Data

NOVEMBER 18, 2020

The most common serious adverse event was fatigue, with 3.7 The trial results — delivered less than a year after researchers began working on the vaccine — shattered all speed records for vaccine development, the Times reported. The vaccine’s efficacy was consistent across age, race and ethnicity, the companies said.

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The Pharma Data

DECEMBER 16, 2020

Forward-looking statements in this press release include, without limitation, the ability of the Company and WPD to initiate clinical trials during the first quarter of 2021, and whether the planned clinical trial will provide data to the FDA to allow an expedited pathway for development. . .

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The Pharma Data

DECEMBER 21, 2020

However, Myovant’s drug dropped the percentage of major cardiovascular events to 2.9% The secondary endpoint for increasing lifespan for patients with metastatic prostate cancer came in at 74% still alive after treatment with Orgovyx compared to 75% of those on Lupron. . compared to AbbVie’s at 6.2%.

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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. Read about more recent corporate appointments here.

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