Drug Target Review

MAY 27, 2024

At a base-layer, Caris’ comprehensive molecular profiling that we perform for patients today can identify predictive biomarkers for current FDA-approved ADCs. What role do ADCs play in Caris’ strategy for targeted cancer therapy, particularly in terms of patient-specific treatment plans? Examples include HER2-low and FOLR1.

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Clinical Trials Science Molecular Biology Bioinformatics 59

Eye on FDA

JANUARY 16, 2023

In 2012 there were 35 meetings held by FDA for the purpose of considering new drug approval which is almost 3 meetings a month. Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased. So that is one – albeit small – way in which AdComms have changed.

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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. That PTE application was submitted to the PTO on July 26, 2012.

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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?

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Therapies Treatment Engineering Molecular Biology 59

NIH Director's Blog: Drug Development

JUNE 14, 2016

That’s critical considering that just 1 in 10 drug candidates entering human clinical trials successfully goes on to receive FDA approval [5]. 2012 Jul 6;337(6090):100-104. [4] 4] Victoza® significantly reduced the risk of major adverse cardiovascular events in the LEADER Trial. Novo Nordisk. 2016 March 4. [5]

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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). About 30,000 Americans have CF. As exciting as that was, we knew it represented just the first step on a challenging road to helping all people with CF.

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The Pharma Data

DECEMBER 30, 2020

The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Posted: December 2020.

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The Pharma Data

OCTOBER 21, 2020

Shionogi joined in October 2012. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Such factors include, but are not limited to, those described under Item 3.D Source: GSK . Posted: October 2020. Source link.

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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). 24 August 2022. AOP Health.

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The Pharma Data

NOVEMBER 26, 2020

Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Protalix’s unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc.

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Agency IQ

JUNE 7, 2024

One is Prevagen (Apoaequorin; Quincy), a dietary supplement marketed as a memory enhancer, which received a denial in 2012. Although this product has received continued scrutiny because of its advertising claims, its presence on the market despite a denied NDIN has never resulted in action from the FDA.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights in the wake of an adverse FDA approval decision. 110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub.

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The Pharma Data

DECEMBER 29, 2020

Protalix was the first company to gain FDA approval of a protein produced through plant cell-based in suspension expression system. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries.

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Broad Institute

MAY 21, 2025

In 2012, the University of Pennsylvania team and Novartis launched a collaboration to further develop the technology, which led to the FDA approval for the first commercial CAR T-cell therapy in 2017. A single dose of the engineered cells wiped out signs of disease.

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Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. Therapeutics There are no FDA-approved therapies built upon Cas12, but the enzyme is currently being used in multiple clinical trials. Visit our website to get a copy. Join Asimov Press. It will always be free.

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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.

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Drug Target Review

JUNE 21, 2023

Human genetics evidence supports two-thirds of the 2021 FDA-approved drugs. 2012 Apr 30;11(5):349-50. 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. Nat Rev Drug Discov. 2022 Aug;21(8):551. PMID: 35804044.

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The Pharma Data

OCTOBER 30, 2020

Gilead’s Veklury (remdesivir) is First Approved Treatment for COVID-19 . In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). Venclexta, an oral B-cell lymphoma-2 (BCL-2) inhibitor, was previously granted provisional approval in Nov.

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The Pharma Data

DECEMBER 18, 2020

J Am Soc Nephrol (2012); 23:1631-1634. Related Articles: Roxadustat FDA Approval History. National Institute of Diabetes and Digestive and Kidney Diseases. Anemia in Chronic Kidney Disease; 2014 [cited 10 December 2020]. Available from: URL: [link] 2. Babitt JL, Lin HY. Mechanisms of Anemia in CKD. Am J Kidney Dis. .

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The Pharma Data

OCTOBER 9, 2021

Currently there are no FDA-approved treatments for EoE. Amgen collaboration In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for tezepelumab. Patients are often treated with corticosteroids to manage inflammation. In EoE, a Phase III trial is planned.

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The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Tax Petition. In July 2021, we filed a petition in the U.S.

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Agency IQ

JULY 8, 2024

Six years later with the reauthorization of several FDA-industry user fee programs in 2012, Congress took the opportunity to set a series of policy changes into motion. FDASIA also addressed a challenge cited by then-CDER Director JANET WOODCOCK when she testified before Congress in March 2012 on medical gases.

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Agency IQ

JUNE 16, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. The rule, will also, if finalized, address communication with State boards of pharmacy.

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Agency IQ

OCTOBER 27, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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Agency IQ

OCTOBER 6, 2023

While stimulant use disorder is increasing, there are currently no FDA-approved medications. Stimulant use disorder is acknowledged in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with severity levels ranging from mild to severe.

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Codon

MARCH 24, 2024

In 2012, an Israeli company called Protalix gained approval for their plant-based enzyme product for Gaucher’s disease. Kanuma, their FDA-approved protein product for rare lysosomal diseases, is “purified from the egg white of transgenic hens.”

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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] Haematologica.

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Agency IQ

SEPTEMBER 29, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. “Globocan 2012: Prostate Cancer: Incidence, Mortality and Prevalence Worldwide, 2012.” 2 ERLEADA ® received U.S. Accessed February 2021. iii] World Health Organization.

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Agency IQ

DECEMBER 1, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List.

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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. 2012 Feb;26(1):147-56. 2 In August 2019 , RINVOQ received U.S. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. Duarte G.V.,

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New Drug Approvals

APRIL 27, 2025

3] It was patented in 1966 and approved for medical use in 1974. [6] 6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. It became generic in the EU in 2009, and the first extended-release generic was approved in the US in 2012. 12 October 2012. 28 May 2004.

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New Drug Approvals

APRIL 21, 2025

SNDX-50613 free base SNDX-5613 free base SNDX50613 free base SNDX5613 free base FDA APPROVED 11/15/2024, Revuforj , To treat relapsed or refractory acute leukemia N -ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro- Food and Drug Administration (FDA) (Press release).

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New Drug Approvals

MAY 20, 2025

Retrieved 15 February 2024. ^ “Bausch + Lomb and Novaliq Announce FDA Approval of Miebo (Perfluorohexyloctane Ophthalmic Solution) for the Treatment of the Signs and Symptoms of Dry Eye Disease” (Press release). Bausch + Lomb Corporation. 18 May 2023. September 2024). 86 (9): 52925298. doi : 10.1097/MS9.0000000000002322.

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Codon

AUGUST 26, 2024

In 2012, a research group at MIT isolated the major components of mucus from pig stomachs (“porcine gastric mucins”) and tested its ability to inhibit infections caused by human papillomavirus, influenza virus, and Merkel cell polyomavirus. PCANS can be freely purchased online. A look inside Panoplia Laboratories.

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RNA Virus DNA Vaccine 107

New Drug Approvals

APRIL 13, 2025

Olezarsen FDA APPROVED 12/19/2024, Tryngolza , To treat familial chylomicronemia syndrome Drug Trials Snapshot Synonyms AKCEA-APOCIII-LRX ALL-P-AMBO-5′-O-(((6-(5-((TRIS(3-(6-(2-ACETAMIDO-2-DEOXY-.BETA. 1] Olezarsen was approved for medical use in the United States in December 2024. [1] 19 December 2024. Epub 2024 Sep 26.

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New Drug Approvals

APRIL 27, 2025

3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] 3] Flurpiridaz ( 18 F) was approved for medical use in the United States in September 2024. [3] Food and Drug Administration (FDA). Food and Drug Administration (FDA). Epub 2012 Dec 19. mmol) and Na 2 CO 3 (0.33

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