The Pharma Data

JUNE 17, 2022

The adalimumab reference medicine (Humira ®* ) was first approved with an adalimumab concentration of 50 mg/mL. 2,3 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL.

Biosimilars 52

Biosimilars Pharmacokinetics FDA Approval Packaging 52

New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release). March 2015). AOP Health.

FDA 62

FDA Clinical Trials Treatment Trials 62

Molecule Blog

AUGUST 13, 2021

If successful, this work could result in the repurposing of several FDA-approved therapeutics for the purpose of extending the human lifespan, at a lower cost and over faster timelines than conceivably possible with de novo drug discovery. The Scheibye-Knudsen lab has analyzed 1.5 billion prescriptions from 4.8

FDA Approval 52

FDA Approval DNA Small Molecule FDA 52

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. Patent Nos.

FDA 59

FDA Production FDA Approval Licensing 59

The Pharma Data

APRIL 4, 2023

The adalimumab reference medicine (Humira ® *) was first approved with an adalimumab concentration of 50 mg/mL. 1 In 2015, the EMA and US FDA approved Humira ® HCF, which contains adalimumab at a concentration of 100 mg/mL.

Biosimilars 40

Biosimilars Pharmacokinetics FDA Approval Packaging 40

The Pharma Data

JUNE 28, 2021

The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.

Therapies 40

Therapies Disease Treatment FDA Approval 40

Drug Target Review

OCTOBER 17, 2024

This year we completed investigational new drug (IND) enabling studies of ONC-841, which is an antagonist of Siglec-10, and received US Food and Drug Administration (FDA) approval for first-in-human study (FIH) in patients with solid tumours. The first patient has been dosed in the last quarter.

Immune Response 52

Immune Response Clinical Trials Trials Therapies 52

Drug Target Review

AUGUST 29, 2024

MR : Chimeric antigen receptor T-cell (CAR-T) therapy is very effective in treating patients with B-cell lymphoma, leukemia, and multiple myeloma, where we have six FDA-approved drugs. What potential advantages does the CD5 modulation strategy offer over traditional CAR-T therapies?

Therapies 59

Therapies Treatment Engineering Molecular Biology 59

NIH Director's Blog: Drug Development

JULY 20, 2017

The first major advance in molecularly targeted drug treatment for the disease came in 2012, when the Food and Drug Administration (FDA) approved ivacaftor (Kalydeco). The next major milestone on the therapeutic pathway was the FDA’s approval in 2015 of Orkambi, a drug that combines ivacaftor with lumacaftor, the first “corrector”.

Clinical Trials 52

Clinical Trials Small Molecule Disease Therapies 52

The Pharma Data

NOVEMBER 23, 2020

Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals. .” Recently, the U.S. References.

FDA Approval 40

FDA Approval Trials Treatment Virus 40

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: For FDA 1572 is a Statement of Investigator under US Regulations/Laws.

Packaging 52

Packaging FDA Trials Regulations 52

Codon

MARCH 28, 2023

The recipient rat was able to perform a task, which normally took eight weeks to learn, in seconds, according to comments made by program manager, Geoff Ling, at a 2015 DARPA event. RAM, which launched in 2015, funded additional groups at the University of Pennsylvania and elsewhere. That had to help!

Engineering 52

Engineering Research Science FDA Approval 52

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. Four comments were submitted to the docket established for the 2015 Petition.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

FDA 40

FDA Pharmacy Drugs Production 40

The Pharma Data

FEBRUARY 4, 2021

Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). and by AbbVie outside of the U.S. AbbVie announced that the U.S.

Production 52

Production Clinical Trials International Small Molecule 52

Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. Cas12 Discovery Cas12 was initially characterized in 2015 by Feng Zhang’s lab at the Broad Institute 5 and was quickly adopted as a complementary genome editor to Cas9.

DNA 78

DNA RNA Clinical Trials Engineering 78

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. Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021.

FDA Approval 40

FDA Approval FDA Production Drugs 40

Drug Target Review

JUNE 21, 2023

Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. 2015 Sep 29;6:8382. 2015 Nov 19;163(5):1204-1213. Epub 2015 Nov 12. Why Clinical Trials Stop: The Role of Genetics. medRxiv; 2023. DOI: 10.1101/2023.02.07.23285407. Ochoa D, Karim M, Ghoussaini M, Hulcoop DG, McDonagh EM, Dunham I.

Disease 111

Disease Clinical Trials Therapies Science 111

The Pharma Data

JULY 29, 2021

First approved in 2015 for severe eosinophilic asthma (SEA), mepolizumab is the first-in-class monoclonal antibody that targets IL-5. The resultant swellings can grow in both nostrils (bilateral) greatly impacting a patient due to various symptoms including nasal obstruction, loss of smell, facial pressure and nasal discharge.

FDA Approval 52

FDA Approval Clinical Trials FDA Treatment 52

FDA Law Blog: Biosimilars

AUGUST 7, 2024

Each of these issues, says Novartis, “independently renders the agency’s decision unlawful, and invalidates the agency’s approval of the MSN product.” While denying a Citizen Petition from Novartis asking FDA to refuse to approve any ANDA that omits the new dosing regimen or changes the indication, FDA approved MSN’s ANDA on July 24, 2024.

FDA Approval 59

FDA Approval FDA Hospitals Regulations 59

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

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

MARCH 15, 2022

To further facilitate generic drug development, and to assist the generic pharmaceutical industry in this process, the FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their brand name counterparts.

FDA Approval 52

FDA Approval FDA Production Drug Development 52

The Pharma Data

MARCH 31, 2023

” Narcan nasal spray was first approved by the FDA in 2015 as a prescription drug. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

FDA Approval 40

FDA Approval FDA Production Drugs 40

Common Sense for Drug Policy Blog

OCTOBER 1, 2024

2022 ; Neale & Strang, 2015 ) Providers may find it difficult to manage withdrawal symptoms and comorbidities like chronic pain, forcing the patient to suffer until the reversal agent wears off. 2023 ) Additionally, the FDA approved intranasal naloxone for over-the-counter use in March 2023. Bennett et al., Brenner et al.,

FDA Approval 52

FDA Approval FDA Marketing Research 52

PLOS: DNA Science

SEPTEMBER 5, 2024

A Brief History of Targeted Cancer Drugs In 1978, FDA approved the first targeted cancer drug, tamoxifen. The FDA approved Herceptin , targeting a different receptor (HER2) in breast cancer cells, in 1998. Keytruda illustrates more recently approved cancer drugs.

Treatment 68

Treatment FDA Approval DNA Small Molecule 68

Dark Matter Blog

AUGUST 27, 2020

In early August, risdiplam, an orally available small molecule that binds to a stem-loop structure in the SMN2 pre-mRNA, received FDA approval for the treatment of spinal muscular atrophy , a devastating genetic disease. The agent, onasemnogene abeparvovec, was approved by the FDA in 2019 and is marketed as Zolgensma.

Small Molecule 52

Small Molecule RNA Drugs Clinical Trials 52

Metabolite Tales Blog

MAY 12, 2023

In 2021, almost one third of FDA approved drugs contained at least one fluorine. ACS Medicinal Chemistry Letters 2015 6 (8), 925-929, [link] [11] Kinesin Spindle Protein (KSP) Inhibitors. Xiaojing Wang, Minghua Sun, Connie New, Spencer Nam, Wesley P. Blackaby, Alastair J. Hodges, David Nash, Mizio Matteucci, Joseph P.

Drugs 52

Drugs Small Molecule FDA Approval Metabolic Stability 52

The Pharma Data

SEPTEMBER 8, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries.

Research 52

Research Immune Response Treatment Trials 52

Agency IQ

JANUARY 19, 2024

Similarly, only one product in 2023 was recommended for approval under “ exceptional circumstances ” – Loargys. This approval type has always been uncommon – before the pandemic, this pathway was used just eight times between 2015 and 2019. [ See AgencyIQ’s analysis of this approval type from 2015-2021 here.]

Biosimilars 40

Biosimilars FDA Production Treatment 40

The Pharma Data

AUGUST 17, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries.

Treatment 52

Treatment Immune Response Trials FDA Approval 52

The Pharma Data

JUNE 30, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Treatment 52

Treatment Trials FDA Approval Disease 52

The Pharma Data

MARCH 2, 2021

Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID-19.

Vaccine 52

Vaccine Clinical Trials FDA Trials 52

Agency IQ

JULY 8, 2024

During a House Energy and Commerce (E&C) Health Subcommittee meeting , Woodcock explained that certain medical gases have been used for so long in medicine that they actually predate the establishment of the FDA’s review practice and thus, were technically being used without any sort of FDA approval.

FDA 40

FDA Regulations Production Packaging 40

The Pharma Data

APRIL 11, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Trials 52

Trials Treatment Immune Response Clinical Trials 52

Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

Regulations 40

Regulations FDA Science Production 40

The Pharma Data

MARCH 11, 2021

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. 1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Treatment 52

Treatment Trials Therapies FDA Approval 52