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.,

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The Pharma Data

JANUARY 17, 2021

plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields. are expected to be approved by the U.S. .

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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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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.

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The Pharma Data

SEPTEMBER 28, 2020

The FDA has announced its approval of GlaxoSmithKline’s Nucala (mepolizumab) as a treatment for hypereosinophilic syndrome (HES). . This approval comes after GSK submitted results from its Phase 3 trial which enrolled 108 patients. It also received approval in 2019 to treat severe eosinophilic asthma in children. .

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The Pharma Data

OCTOBER 26, 2020

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. Over-the-counter treatments fail due to the body’s natural protective system. Roughly 16.4

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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

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The Pharma Data

MARCH 31, 2023

Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. The FDA granted the OTC approval of Narcan to Emergent BioSolutions.

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The Pharma Data

OCTOBER 31, 2020

Food and Drug Administration (“FDA”) has approved the Investigation New Drug (IND) application for TG-1000, a novel treatment for influenza A and B. With the IND approval in place, we are ready and eager to extend the clinical study of TG-1000 to the U.S. billion USD in 2019 and is estimated to reach 5.03

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Drug Discovery World

MARCH 7, 2023

She has previously been named an MIT Technology Review Top Innovator Under 35, a Forbes 50 Top Women In Tech, a Deloitte Fast 50 Women in Leadership, and has won several prizes, including CEO of Year 2019 at the Cambridge Independent Science and Technology Awards and Best Female-Led Startup at the StartUp Europe Awards in 2019.

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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] World Health Organization (2019).

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The Pharma Data

AUGUST 20, 2020

The FDA has approved its first generic of Biogen’s multiple sclerosis (MS) treatment Tecfidera, awarding authorisation to Mylan which is launching the drug in a dimethyl fumarate delayed-release oral solid formulation, both in 120mg and 240mg doses. billion for Biogen through 2019. The drug generated $3.79 Matt Fellows.

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The Pharma Data

FEBRUARY 8, 2021

Janssen Announces Treatment with ERLEADA ® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer. ERLEADA ® is an androgen receptor (AR) inhibitor indicated for the treatment of patients with nmCRPC and for the treatment of patients with mCSPC. 10 months. [5]

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Drug Discovery World

APRIL 23, 2024

More than 413,000 service members were diagnosed with a TBI between 2000 and Q3 of 2019. Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI. Concussion treatment has received less attention and has focused on rest as a first line therapy.

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Agency IQ

OCTOBER 6, 2023

In a first, FDA tackles treatments for stimulant use disorder A new draft guidance from the FDA gives developers a roadmap to advance the development of novel therapies to address stimulant use disorders. While stimulant use disorder is increasing, there are currently no FDA-approved medications.

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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] World Health Organization (2019).

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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. .

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The Pharma Data

FEBRUARY 25, 2022

“Today’s announcement builds on our commitment to broaden access to essential, high-quality and cost-effective treatment options for patients living with certain chronic inflammatory conditions.”. Biosimilars play an important role in the treatment of autoimmune conditions.

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The Pharma Data

APRIL 3, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adults and adolescents with moderate to severe atopic dermatitis. In August 2019 , RINVOQ received U.S. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg.

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The Pharma Data

JUNE 6, 2022

1] [2] In recent years, measles outbreaks have occurred in the US and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries. [3]. Contraindications for Priorix are: severe allergic reaction (e.g.,

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The Pharma Data

JUNE 28, 2021

“Despite available treatments, many people with moderate to severe forms of this disease continue to experience a relentless and burdensome cycle of skin and itch symptoms. We are encouraged that the CHMP has recognized RINVOQ’s potential as an additional treatment option for these patients.”

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Drug Discovery World

AUGUST 14, 2023

These advanced therapies are revolutionising treatment options and opening new avenues for targeted and individualised healthcare, offering tremendous promise to patients worldwide, including those living with life-threatening or debilitating diseases. The EMA, however, doesn’t require the use of an agency-approved diagnostic.

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The Pharma Data

JANUARY 18, 2021

Given the pandemic, 2020 can’t be viewed as a typical year, but Prevision noted that the number of applications for new drugs or indications sent to the committees had already decreased steadily pre-pandemic, with only 23 in 2019 and 30 in 2018.

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The Pharma Data

APRIL 27, 2021

Patients with EGFR Exon20 insertion+ mNSCLC face considerable challenges, as current treatment options provide limited benefit, resulting in poor survival outcomes,” said Christopher Arendt, head, Oncology Therapeutic Area Unit, Takeda. “We In 2019, the U.S. and around the globe.”. For more information, visit www.takedaoncology.com.

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

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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] June 2019). 1] It is taken by mouth. [1] 11] SYN ACS Med.

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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. Before 1983, only 38 orphan drugs had received U.S.

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Drug Discovery World

APRIL 14, 2023

Pettit Nassi and Perlmutter will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET. Simon’s award lecture will be held on Sunday April 16 at 3pm ET.

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The Pharma Data

JANUARY 15, 2021

hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu ( fam-trastuzumab deruxtecan -nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. In the U.S.,

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The Pharma Data

NOVEMBER 15, 2020

Urovant’s lead drug candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist being evaluated for the treatment of OAB, abdominal pain associated with irritable bowel syndrome (IBS) in men with OAB, and for men suffering from OAB with benign prostatic hyperplasia (BPH).

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The Pharma Data

NOVEMBER 8, 2021

“The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine.” “The positive outcomes strengthen the efficacy and safety profile of erenumab as a migraine prevention treatment for patients with migraine.” versus 38.9%). .

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PerkinElmer

JANUARY 7, 2022

As expected, epinephrine treatment led to an increase in cardiomyocyte beating rate. Sci Rep 9, 18911 (2019). link] New safety concerns identified for 1 in 3 FDA-approved drugs [Internet]. References Hingorani, A.D., Improving the odds of drug development success through human genomics: modelling study.

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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). The approval marks the first drug approved by the U.S. Testing Therapies, Antivirals and Vaccines.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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Drug Target Review

JULY 5, 2024

Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. 22:669-679 (2019). A regenerative approach to the treatment of multiple sclerosis. References Giandomenico SL, et al. Pharmaceutics.

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Agency IQ

JANUARY 19, 2024

When compared to the year immediately prior to the pandemic, however, 2023 actually marks an increase in volume, with only 70 opinions issued in 2019. Similarly, only one product in 2023 was recommended for approval under “ exceptional circumstances ” – Loargys. See AgencyIQ’s analysis of this approval type from 2015-2021 here.]

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