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.

FDA Approval 52

FDA Approval FDA Treatment Pharmaceuticals 52

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.

FDA Approval 52

FDA Approval Treatment FDA Therapies 52

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.

FDA Approval 52

FDA Approval FDA Treatment Disease 52

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.

FDA Approval 52

FDA Approval Therapies FDA Treatment 52

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.

FDA Approval 52

FDA Approval FDA Clinical Trials Therapies 52

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.

FDA Approval 52

FDA Approval Treatment FDA RNA 52

The Pharma Data

JUNE 26, 2023

FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata Pfizer Inc. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. with placebo.

FDA Approval 40

FDA Approval FDA Clinical Trials Treatment 40

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.

FDA Approval 52

FDA Approval FDA Therapies Pharmacokinetics 52

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.,

FDA Approval 52

FDA Approval FDA Clinical Trials Disease 52

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.

FDA Approval 52

FDA Approval FDA Science Therapies 52

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

FDA Approval 40

FDA Approval FDA Production Drugs 40

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.

FDA Approval 52

FDA Approval Treatment FDA Pharmaceutical Companies 52

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.

Therapies 52

Therapies Treatment Trials FDA 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119

Therapies FDA FDA Approval Treatment 119

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.

FDA Approval 40

FDA Approval FDA Treatment Trials 40

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

FDA Approval 52

FDA Approval FDA Treatment Therapies 52

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.

FDA Approval 52

FDA Approval FDA Treatment Hospitals 52

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.

FDA Approval 52

FDA Approval FDA Vaccine Virus 52

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. . .

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

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%.

FDA Approval 52

FDA Approval FDA Therapies Drugs 52

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.

FDA Approval 52

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

FDA Approval 40

FDA Approval FDA Treatment Therapies 40

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.

FDA Approval 40

FDA Approval FDA Clinical Trials Treatment 40

The Pharma Data

JULY 12, 2021

The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits). Bayer announced today that the U.S.

FDA Approval 52

FDA Approval Disease FDA Treatment 52

Eye on FDA

AUGUST 4, 2021

Also the vacancies on the Peripheral and Central Nervous System Drugs Advisory Committee largely reflect the protest of the FDA approval decision in Alzheimer’s.

FDA 122

FDA Clinical Pharmacology FDA Approval Therapies 122

The Pharma Data

JULY 8, 2021

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation uncertainty of success in the development and commercialization of ADUHELM; risks relating to the launch of ADUHELM, including preparedness of healthcare providers to treat patients, (..)

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

MAY 31, 2022

There were no treatment-related adverse events leading to withdrawal. “The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, M.D.,

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

MARCH 28, 2022

Ozempic ® is now approved in the US at 0.5 Further, Ozempic ® is indicated to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease. The FDA approval is based on the results from the SUSTAIN FORTE trial. mg and 2.0

Treatment 52

Treatment FDA Approval Trials FDA 52

The Pharma Data

MAY 7, 2021

FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at [link] by calling 1-800-822-7967.

Licensing 52

Licensing Licensing Vaccine FDA Approval 52

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccine 52

Vaccine FDA Approval FDA Disease 52

The Pharma Data

JANUARY 21, 2021

These events may have been associated with inadvertent (partial) intravenous administration and began to resolve within a few minutes after the injection. Hepatotoxicity: Hepatic adverse events were reported. The causal relationship, mechanism, and long-term consequences of these events have not been established.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

FDA Approval 40

FDA Approval FDA Treatment Clinical Trials 40

The Pharma Data

JULY 29, 2021

Discontinue Nucala in the event of a hypersensitivity reaction. Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of Nucala. Do not use to treat acute bronchospasm or status asthmaticus. Herpes zoster infections have occurred in patients receiving Nucala.

FDA Approval 52

FDA Approval Clinical Trials FDA Treatment 52

The Pharma Data

DECEMBER 1, 2020

In order to listen to the audio webcast, interested parties can register and access the live webcast under “News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. ABOUT AURINIA.

Pharmaceuticals 52

Pharmaceuticals FDA Approval FDA Therapies 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. The primary endpoint was the frequency of all adverse events, including serious adverse events.

FDA Approval 40

FDA Approval Treatment FDA Clinical Trials 40

BMG Labtech

JANUARY 18, 2023

And if you need to take an FDA-approved drug, there’s around a one in three chance that it’s a drug that targets a GPCR. But what are the best ways to study this diverse group of molecules and the cascade of signaling events that ensue in the cell?

FDA Approval 52

FDA Approval FDA Research Drugs 52

The Pharma Data

NOVEMBER 8, 2021

” In this head-to-head Phase IV study, patients in the Aimovig arm demonstrated a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm (10.6% Additional study treatment-related adverse events reported by ?2% versus 38.9%). .” versus 38.9%). versus 31.2%).

Therapies 52

Therapies FDA Approval Treatment Small Molecule 52