Vial

JUNE 12, 2024

To improve how it assesses the benefit of positive PROs in HF, for example, the FDA works with academia to explore how previously developed PRO instruments may be modified to capture outcomes of diverse patient groups adequately. Use of PRO assessments Specifically for oncology drugs, Moore et al.

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

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.

Drugs 52

Drugs Metabolic Stability FDA Approval Treatment 52

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.

Metabolic Stability 52

Metabolic Stability Drugs FDA Approval Treatment 52

Advarra

JULY 19, 2022

The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. Q: When you want to do a study of an FDA-approved drug under an investigational indication, is an IND still required or can you seek an exemption? A: It depends, but the answer is usually yes. of this guidance. of this guidance.

Packaging 52

Packaging FDA Trials Regulations 52

The Pharma Data

SEPTEMBER 7, 2020

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) . Atlas of MS 2013. Adv Studies Pharm.

Therapies 52

Therapies Treatment Clinical Trials Disease 52

The Pharma Data

SEPTEMBER 10, 2021

Overview of the Population of Patients with Advanced Parkinson’s Disease (aPD) Initiating Therapy with Levodopa-Carbidopa Intestinal Gel (LCIG): POMPE-PARK Study on French Health Insurance Data (2013-2017). BOTOX ® Abstracts. OnabotulinumtoxinA Treatment in Patients with Upper Limb and Lower Limb Spasticity from the ASPIRE Study.

Doctors 52

Doctors Clinical Trials Disease Treatment 52

Broad Institute

APRIL 25, 2024

Christian Happi and Pardis Sabeti on the campus of Redeemer's University in 2013. Christian Happi and Pardis Sabeti on the campus of Redeemer's University in 2013. In 2013, Happi and Sabeti applied to the World Bank for support to establish a genomic center of excellence in Nigeria. Scientists train at ACEGID in October 2013.

Virus 132

Virus Hospitals Disease Government 132

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.

FDA Approval 40

FDA Approval FDA DNA Therapies 40

The Pharma Data

DECEMBER 21, 2020

2013:6;2800-12. 2013:66;79-89. Related Articles: Tagrisso (osimertinib) FDA Approval History. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. Keedy VL, et al. J Clin Pathol.

Treatment 52

Treatment Trials Disease FDA 52

The Pharma Data

OCTOBER 14, 2020

Risks and uncertainties related to these endeavors include, but are not limited to, obtaining FDA approval of NantKwest’s NK cells and MSC as well as other therapeutics and manufacturing challenges. 2013 Aug;62(8):1293-301. Epub 2013 Apr 30. Cancer Immunol Immunother. doi: 10.1007/s00262-013-1400-3. iv Osada T, et al.

Vaccine 40

Vaccine Trials FDA Clinical Trials 40

The Pharma Data

JUNE 18, 2021

” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study. IMBRUVICA ® is the only FDA-approved medicine in WM and cGVHD.

FDA Approval 40

FDA Approval Treatment Therapies FDA 40

New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. and > 300 mg/mL at lower pH pKa 4.8 2021 Jan 1;31:127624.

Clinical Trials 40

Clinical Trials Treatment Trials FDA 40

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Through this program, the FDA can conduct periodic stability testing on select products and extend the labeled shelf life accordingly.

Science 40

Science FDA Production Packaging 40

Agency IQ

JUNE 2, 2023

Curiously, there is no direction for the patient to seek out the full FDA-approved labeling. Information included in the PMI : FDA intends that the PMI would “highlight the most important information that patients need to know to help them use their prescription drug products safely and effectively.”

FDA 40

FDA FDA Approval Production Regulations 40

Codon

JULY 14, 2024

Biotechnology Journal (2013). Despite the initial promise of PFCs and FDA approval of a product called Fluosol-DA in 1989, PFCs have many drawbacks. A cost analysis to make one unit of red blood cells from stem cells. Data from Rousseau G.F. Each particle includes a lipid shell and a liquid core containing biomolecules.

Production 143

Production Clinical Trials Trials Therapies 143

The Pharma Data

NOVEMBER 4, 2020

VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. 500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over eight million times.

Production 40

Production Trials FDA Disease 40

Codon

MAY 22, 2023

“ The Anthropocene by the Numbers ” (2021) Between 2011-2013, China made more concrete than America did in the entire 20th century. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. We make a lot of concrete. This is bad.

DNA 64

DNA Engineering Science Trials 64

Codon

MAY 22, 2023

“ The Anthropocene by the Numbers ” (2021) Between 2011-2013, China made more concrete than America did in the entire 20th century. The FDA approved a rub-on gene therapy for dystrophic epidermolysis bullosa, a genetic condition that causes sensitive, fragile skin. We make a lot of concrete. This is bad.

DNA 52

DNA Engineering Science Trials 52

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. BTK signaling is needed by specific cancer cells to multiply and spread.

Treatment 52

Treatment Therapies FDA FDA Approval 52

The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. 10, October 2013 , pp 1600–1607. 3 In August 2019 , RINVOQ received U.S. Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032. Data on File, ABVRRTI64959.

Treatment 40

Treatment Disease Therapies Clinical Trials 40

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. BTK signaling is needed by specific cancer cells to multiply and spread.

Treatment 40

Treatment FDA Therapies FDA Approval 40

New Drug Approvals

APRIL 27, 2025

13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15] 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] November 2013). billion in 2004. [23]

FDA Approval 59

FDA Approval FDA Pharmacokinetics Licensing 59

New Drug Approvals

APRIL 27, 2025

3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] Food and Drug Administration (FDA). Jump up to: a b c d e f g h i j k “FDA approves imaging drug for evaluation of myocardial ischemia” U.S. Food and Drug Administration (FDA). 2013 Jan 29;61(4):469-477.

FDA 59

FDA Clinical Trials FDA Approval Disease 59

Drug Target Review

JANUARY 16, 2025

Food and Drug Administration (FDA) approved drugs, macrocycles are used to combat a range of diseases, including cancer, viral, fungal and bacterial infections, neurodegenerative and autoimmune diseases. Drug Discovery Today , 18(13-14):659666, 2013. 5 Macrocycles as drugs Despite accounting for just four percent of the U.S.

Drug Development 52

Drug Development Small Molecule Drugs FDA Approval 52

Agency IQ

MAY 3, 2024

As described in the guidance, the FDA “intends to look at the testing needs of the emergency response,” including “the number of, and access to, FDA-approved/authorized tests available and how time sensitive the need for a test is.” Factor 1: Need.

FDA 40

FDA Laboratories Regulations Production 40

New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 2013 Jun 11;110(24):9992-7. June 2013). Jump up to: a b c d e f g h i j k “FDA approves drug for heart disorder caused by transthyretin-mediated” U.S.

FDA Approval 64

FDA Approval FDA Production Treatment 64

Codon

NOVEMBER 1, 2024

This technique " opens large windows into the cell’s interior ," according to a 2013 review, allowing visualization of hidden structures that can’t be easily extracted or crystallized. Today, a single injection of an FDA-approved gene therapy, called Hemgenix , cures this disease. Credit: SIngh U.S.

DNA 132

DNA RNA Molecular Biology Laboratories 132

Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates.

Clinical Trials 80

Clinical Trials Virus Vaccine DNA 80

Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

FDA Approval 52

FDA Approval Clinical Trials Trials FDA 52

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Cartridge Co. ,

Production 52

Production FDA Approval FDA Compliance 52

Drug & Device Law

FEBRUARY 11, 2024

Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. FDA , 715 F.3d 2013) (Kavanaugh, J.). Cytori Therapeutics, Inc. 3d 922, 927 (D.C.

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. 13) McGee v.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

DECEMBER 21, 2023

Bexis’ amicus efforts this year in Mallory obviously came to naught, and we’ve had our own cases on this list before (see, e.g. , 2013-2 and 2021-10 ). That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. A lawyer who never loses doesn’t litigate hard cases.

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

NOVEMBER 2, 2023

Qualifying compounding pharmacies do not require FDA approval to sell compounded drugs. The defendant in Zyla is a qualifying compounding pharmacy that sells without FDA approval a compounded product containing the active ingredient found in the plaintiff manufacturer’s FDA-approved product. Mukasey , 536 F.3d

Compounding Pharmacies 59

Compounding Pharmacies Pharmacy FDA Approval FDA 59

Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. FDA , 715 F.3d

FDA 59

FDA FDA Approval Clinical Trials Pharmaceuticals 59

Drug & Device Law

OCTOBER 13, 2023

2466, 2471 (2013). It makes no difference in our view that the FDA ultimately approved TAF-based drugs. It is undisputed that, at the time the FDA approved the first TDF-based drug, the plaintiff’s proposed “alternative” was not approved, and would not be approved for another 10+ years.

FDA Approval 59

FDA Approval FDA Marketing Science 59

Drug & Device Law

OCTOBER 10, 2023

2013), the court held that plaintiff could not “bring a claim that rests solely on the non-disclosure to patients of facts tied to the scope of [FDA] approval.” Finding non-disclosure different than, for example, a claim premised on false assertions of FDA approval. Nidek Co. , 3d 1109, 1119 (9 th Cir.

FDA Approval 59

FDA Approval FDA Pharmacy Regulations 59