FDA Approved Oncology Drugs 2023
Crown Bioscience
JUNE 6, 2024
This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022.
Metabolism of 2022 FDA approved small molecule drugs PART 1
Metabolite Tales Blog
JANUARY 26, 2023
Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. 2022; 131(5): 311- 324. Tang et al.,
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Metabolism of 2022 FDA approved small molecule drugs PART 2
Metabolite Tales Blog
APRIL 4, 2023
Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Poster at ISSX/MDO 2022 Seattle meeting. [6] Br J Pharmacol.
FDA Approves
The Pharma Data
JUNE 2, 2023
Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Patients should be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. In the U.S., For the U.S.
FDA Approval 
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Tofersen
New Drug Approvals
MAY 17, 2025
Jump up to: a b c d e f g h i j k l “FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene” (Press release). Food and Drug Administration (FDA). “Biogen’s ALS Drug Gets Partial Backing From FDA Panel” Bloomberg News. January 2022).
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Pirtobrutinib
New Drug Approvals
MAY 8, 2025
Food and Drug Administration (FDA). FDA Approves Jaypirca (pirtobrutinib), the First and Only Non-Covalent (Reversible) BTK Inhibitor, for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTK Inhibitor” (Press release). eCollection 2022.
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Metabolism of 2023 FDA Approved Small Molecules – PART 1
Metabolite Tales Blog
JANUARY 23, 2024
Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals. 2] Iversen et al., 131(5): 311- 324.
Inavolisib
New Drug Approvals
APRIL 25, 2025
3] Inavolisib was approved for medical use in the United States in October 2024. [3] 3] Inavolisib was approved for medical use in the United States in October 2024. [3] 2022 Dec 22;65(24):16589-16621. Epub 2022 Dec 1. Food and Drug Administration (FDA). December 2022). J Med Chem. doi: 10.1021/acs.jmedchem.2c01422.
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When the Going Gets Tough – FDA AdComms in 2022
Eye on FDA
JANUARY 16, 2023
By contrast in 2021 there were only 10 (see blue bars below in the chart tracking meetings from 2017 – 2022). Yet in the midst of that range, the number of new molecular entities approved by FDA actually increased. But conversely, in 2022 the number of NMEs plummeted. Pre-pandemic numbers were consistently higher.
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Kite Receives U.S. FDA Approval of New State-of-the-Art CAR T-Cell Therapy Manufacturing Facility in Maryland
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. Our median cycle time is industry leading at 16 days in the U.S.,
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Allergan, an AbbVie Company, to Present Data from its Leading Portfolio of Eye Care Treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting
The Pharma Data
FEBRUARY 24, 2022
Allergan, an AbbVie (NYSE: ABBV) company, today announced new data to be presented from Allergan’s leading portfolio of eye care treatments at the 2022 American Glaucoma Society (AGS) Annual Meeting being held in Nashville, TN and virtually from March 3-6. The DURYSTA data presentations coincide with the two-year anniversary of the U.S.
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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?
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.
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Discover Strategies for Combatting Disruptions in Gene Therapy Development
Fierce BioTech
OCTOBER 5, 2023
Discover Strategies for Combatting Disruptions in Gene Therapy Development Cell and gene therapy development has exploded, with Q4 2022 showing more FDA approvals than over the past five years combined.[1] 1] How can sponsors keep pace with this rapidly growing market and avoid costly delays that can threaten critical timelines?
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Olutasidenib
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] 1 December 2022. J Med Chem.
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Automated red blood cell exchange: bridging treatment gaps in sickle cell disease care
Drug Target Review
JUNE 5, 2025
Currently, three FDA-approved disease-modifying drug therapies are available: hydroxyurea, crizanlizumab and L-glutamine, though each has limitations that affect patient compliance. 2022 Oct 7;71(9):1-18. The use of FDA-approved medications for preventing vaso-occlusive events in sickle cell disease. 2023.44546.
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Elacestrant
New Drug Approvals
MAY 9, 2025
2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Jump up to: a b c d e f g “FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer” U.S. Food and Drug Administration (FDA). 8 February 2023. 27 January 2023.
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Biogen’s Statement on the Final National Coverage Determination for Amyloid-Beta Targeting Therapies for the Treatment of Alzheimer’s Disease
The Pharma Data
APRIL 7, 2022
This unprecedented CMS decision effectively denies all Medicare beneficiaries access to ADUHELM ® (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. About Biogen.
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FDA’s New Priority Voucher Pilot Program Has Landed: CNPV
FDA Law Blog: Drug Discovery
JUNE 18, 2025
As described in a 2022 FDA analysis , the median time-to-approval from submission for RTOR applications was 3.3 As an extreme example, FDA approved a supplement for Adcetris (brentuximab vedotin) for a new indication 11 days following application submission. requirement for new REMS, advisory committee, etc.).
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Crinecerfont
New Drug Approvals
APRIL 18, 2025
2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2] Food and Drug Administration (FDA) (Press release).
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The Role of the FDA’s Oncology Center of Excellence in Advancing Cancer Care
The Premier Consulting Blog
JANUARY 14, 2025
Research and Development Projects Project Pragmatica An initiative to advance evidence generation for approved products Introduce functional efficiencies and enhance patient centricity by integrating aspects of clinical trials with real-world routine clinical practice through appropriate use of pragmatic design elements.
“Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application. And a Corrected NDA Approval Letter is No Saving Grace
FDA Law Blog: Biosimilars
APRIL 21, 2024
But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ? That’s important, because PTE applications for U.S. Patent Nos. Patent Nos.
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Optimising CRIPSR gene editing of hard-to-transfect cells
Drug Target Review
APRIL 12, 2024
This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. In 2022, SEED Biosciences received its very first and prestigious New Product Award. He was awarded with the Ignite Award at SLAS 2019.
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The Year in AdComms – A Look Back at 2023
Eye on FDA
DECEMBER 6, 2023
For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. By contrast, in 2023, the number of recommendations for approval was over three times the number of negative outcomes.
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Optimising CRISPR gene editing of hard-to-transfect cells
Drug Target Review
APRIL 12, 2024
This holds particular significance, as it is a prerequisite for FDA approval in biotechnology that any cell clones must originate from a single-cell progenitor. In 2022, SEED Biosciences received its very first and prestigious New Product Award. He was awarded with the Ignite Award at SLAS 2019.
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Adagrasib
New Drug Approvals
JANUARY 3, 2023
Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]
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Vanda-lay Litigation Industries, Inc.: Taking Stock of Vanda Pharmaceuticals, Inc.’s Big Bets on Petitioning and Litigation Against FDA and the Federal Government
FDA Law Blog: Biosimilars
OCTOBER 1, 2024
FOOD AND DRUG ADMINISTRATION et al Challenge to FDA approval of generic Hetlioz (tasimelteon) Pending 1:2023cv00629 (COFC) VANDA PHARMACEUTICALS, INC. FOOD AND DRUG ADMINISTRATION et al Challenge to FDA approval of generic Hetlioz (tasimelteon) Pending ( Motion to Dismiss Denied-in Part/Granted-in-Part ) 1:2023cv02884 (D.D.C.)
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Biogen and Samsung Bioepis’ BYOOVIZ™ (ranibizumab-nuna) Launches in the United States
The Pharma Data
JUNE 2, 2022
BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from retinal disorders BYOOVIZ will be commercially available through major distributors across the U.S. on July 1, 2022. Biogen Inc.
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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 1)
FDA Law Blog: Biosimilars
FEBRUARY 27, 2024
156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Two PTE applications were submitted to FDA ( See FDA Docket Nos. Patent Nos.
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Sanofi to acquire Kadmon to further strengthen growth of transplant.
The Pharma Data
SEPTEMBER 8, 2021
Adds Rezurock™ (belumosudil) an FDA-approved, first-in-class treatment for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. The transaction is expected to be modestly dilutive to Sanofi’s EPS in 2022. Transaction Terms.
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Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious
FDA Law Blog: Biosimilars
AUGUST 12, 2024
The NADA applicant requested reconsideration, but FDA refused to set the testing phase at the INAD opening and instead used the date that a major health or environmental effects test on the drug was initiated. Plaintiffs performed the necessary studies on BRAVECTO and filed an NADA on April 8, 2014; FDA approved the NADA on May 15, 2014.
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Economic Theory Explains Big Pharma Scare Tactics on Importation
Policy Prescription
OCTOBER 3, 2023
In the summer of 2022, a policy debate in the Senate HELP committee ensued with Sens. Of course, India is the largest supplier of FDA-approved generic drugs sold in U.S. but negotiate higher prices in foreign markets. Consider how this international drug price dynamic may affect the politics of the issue. Many people in the U.S.,
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GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9bn
The Pharma Data
APRIL 15, 2022
In January 2022, Sierra Oncology announced positive topline results from the MOMENTUM phase III trial. New GSK reaffirms its full-year 2022 guidance, the medium-term outlook for 2021-2026 of more than 5% sales and 10% adjusted operating profit CAGR* at CER**, and long-term sales ambition.
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An Evolving Regulatory Environment for Rare and Orphan Diseases
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. FDA Expedited Programs.
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Ocular Therapeutix Announces Receipt of a Permanent Category I CPT Code from the American Medical Association for the Insertion of Intracanalicular Inserts
The Pharma Data
NOVEMBER 3, 2020
mg, effective January 1, 2022. Prior to the January 1, 2022 effective date of the newly issued Category I CPT code, payments to physicians are expected to continue with the service reported using CPT code 0356T. DEXTENZA is FDA approved for the treatment of ocular inflammation and pain following ophthalmic surgery.
Resources, services, and tools
Broad Institute
JULY 26, 2022
Resources, services, and tools By Maria Nemchuk July 26, 2022 Breadcrumb Home Resources, services, and tools Key scientific datasets and computational tools developed by our scientists and their collaborators. Learn more ENCODE Integrated, annotated encyclopedia of functional and regulatory elements in the genome.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
Advarra
NOVEMBER 17, 2022
In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). While the FDA’s approval of nusinersen may not seem extraordinary, it was. Nusinersen’s approval marked the first time nonclinical data supported conducting initial clinical trials involving children. o) define children. [2]
Five Promising Treatment Areas in Early-Phase Drug Development in 2024
Alta Sciences
APRIL 17, 2024
According to a 2022 article published in Molecular Psychiatry, treatment resistance affects 20 to 60% of patients with psychiatric disorders. According to an article published in Frontiers in Pharmacology , as of October 2023, there were 15 FDA-approved ADCs on the market, and more than one hundred in clinical development in the U.S.A.,
Landiolol
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 21 December 2022. 24 August 2022. FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release).
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Eplontersen
New Drug Approvals
DECEMBER 24, 2023
December 2022). S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. .; Schneider, Eugene; Guo, Shuling; Henry, Scott; et al. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634.
Etrasimod
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] July 2022). 1] It is taken by mouth. [1] 401 (10383): 1159–1171.
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Sloane’s Journey with ASO Therapy
KIF1A
APRIL 25, 2024
September 2022 – We were contacted by n-Lorem to obtain blood from Sloane, my husband, and me. However, we needed to wait for Susannah to finish her trial before we could submit to the FDA for Sloane’s ASO use. February 2024 – n-Lorem submitted an IND (investigational new drug) to the FDA for Sloane.
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Next Generation Sequencing (NGS) in Clinical Trials: Challenges and Opportunities
Vial
DECEMBER 5, 2023
In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease. Fountzilas et al.
VUITY™ (pilocarpine HCI ophthalmic solution) 1.25% in Adults with Age-Related Blurry Near Vision (Presbyopia)
The Pharma Data
APRIL 6, 2022
New Drug Application submission in the second quarter of 2022. Food and Drug Administration (FDA) in the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, VUITY is the first and only eye drop to treat age-related blurry near vision in adults.
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Gamida Cell Provides Regulatory Update on Biologics License Application for Omidubicel
The Pharma Data
DECEMBER 13, 2020
Based on the feedback received at the meeting with FDA, Gamida Cell intends to submit a full BLA for omidubicel in the second half of 2021 in lieu of the company’s previous plan to initiate a rolling BLA submission by the end of 2020.
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