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Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities, especially in competitive therapeutic areas.
FDAApproves Merck’s ENFLONSIA™ to Protect Infants from Severe RSV Illness Merck operating as MSD outside the United States and Canada, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for ENFLONSIA™ (clesrovimab-cfor).
Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Koblitz & Kurt R. Similar requirements would apply to BLA sponsors.
2] Fitusiran was approved for medical use in the United States in March 2025. [2] 2] The fixed dose of fitusiran is not approved because it led to excessive clotting in some participants. [2] 2] The US Food and Drug Administration (FDA) granted the application for fitusiran orphan drug and fast track designations. 26 March 2025.
This means ensuring that generic manufacturers adhere to the same quality control standards as brand-name companies, and that patients have access to accurate and reliable information about the medications they're taking. So, what can we do to ensure patient safety with generic drugs? Share your thoughts and experiences in the comments below.
The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information.
link] [4] FDA prescribing information for INPEFA TM (sotagliflozin). link] [6] FDA prescribing information for FABHALTA® (iptacopan). link] [6] FDA prescribing information for FABHALTA® (iptacopan). link] [7] FDA prescribing information for LITFULOTM TM (ritlecitinib). Drug Metab Dispos.
FDAApproves First Over-the-Counter Fully At-Home Test for COVID-19. Last week, the FDAapproved a different at-home test, but it requires samples to be mailed to a lab to get the results. Ellume expects to produce more than 3 million tests in January 2021, the FDA said. More Information. Professional.
FoundationOne Liquid CDx analyses more than 300 cancer-related genes and multiple genomic signatures to help inform treatment decisions for all solid tumour cancers. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes.
FDAApproves Label Update for Lilly’s Amyvid, Expanding Its Role in Alzheimer’s Disease Diagnosis and Therapy Guidance In a major development for Alzheimer’s diagnostics, Eli Lilly and Company (NYSE: LLY) announced that the U.S.
Metabolism of 2022 FDAapproved 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. We hope it was a useful two-parter! We’re looking forward to the next crop!
FDAApproves First Oral Hormone Therapy for Advanced Prostate Cancer. 21, 2020 — Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Approval was granted to Myovant Sciences. More Information. Professional.
FDAApproves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.
Updated drug safety information is available (as of ChEMBL 28 ) for drugs with boxed warnings and for withdrawn drugs. Boxed warnings (also know as black box warnings) are provided on medicinal product labels for FDAapproved drugs if the medicinal product can cause severe or life-threatening side effects.
FDAApproves Genetically Engineered Pigs for Food, Possible Medical Use. 14, 2020 — The first genetically engineered pigs for use as food or for potential future biomedical use — such as transplantation — in humans have been approved by the U.S. More Information. Professional. MONDAY, Dec.
FDAApproves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDAapproved. See below for information related to adverse reactions. Important Safety Information. Indication.
FDAApproves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDAapproval of Klisyri is a significant milestone for Athenex.
FDAApproves Veklury (remdesivir) for the Treatment of COVID-19. Food and Drug Administration (FDA) has approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. The speed and rigor with which Veklury has been developed and approved in the U.S.
Novartis blazoned moment that the US Food and Drug Administration (FDA) approved Scemblix ® (asciminib) for the treatment of habitual myeloid leukemia (CML) in two distinct suggestions. Scemblix is the first FDA-approved CML treatment that binds to the ABL myristoyl pocket1. sites/www.novartis.us/files/scemblix.pdf.
Metabolism of 2023 FDAApproved 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]. link] [3] FDA prescribing information for daprodustat. link] [4] Licea Perez et al., 6(10):e1610.
FDAApproves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. With this approval, Imcivree becomes the first-ever FDAapproved therapy for these rare genetic diseases of obesity. Important Safety Information. BOSTON, Nov.
based subsidiary of Terumo and a global neurovascular company, announced today the FDAApproval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. .
ALISO VIEJO, Calif. ,
We authors eagerly await the publication of FDA’s Summary Basis for Approval for the Duvyzat NDA so that we can better understand the basis for the Agency’s finding of substantial evidence of effectiveness, particularly in light of recent FDA guidance on the topic of single study approvals with confirmatory evidence, available here.
But FDA-approved forms of the most commonly used vehicle for packaging and delivering these therapies to target cells, adeno-associated viruses (AAVs), aren’t able to efficiently cross the blood-brain barrier at high levels and deliver therapeutic cargo.
5] Leniolisib was approved for medical use in the United States in March 2023. [5] 5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] 5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] “Leniolisib: First Approval” Drugs.
2] [4] Sunvozertinib was approved for medical use in the United States in July 2025. [1] 5] In China, it was conditionally approved in 2023 for the treatment of NSCLC and full approval is contingent on results of phase 3 clinical trials. [6] Sunvozertinib CAS 2370013-12-8 DZD9008, 584.1
ABBOTT RECEIVES FDAAPPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. 1 The TactiFlex catheter is also approved for use in Europe, Japan, Africa and Australia.
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 FDAapproved CAR T-cell therapy used to treat blood cancer. For more information on Kite, please visit www.kitepharma.com.
Valentine — On November 22, 2022, FDAapproved 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.
FDAApproves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency NEW YORK & MIAMI–(BUSINESS WIRE)– Pfizer Inc. NGENLA is approved for the treatment of pediatric GHD in more than 40 markets including Canada, Australia, Japan, and EU Member States. Source link: [link]
The press release describes the CNPV process as a “team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices.” We look forward to additional information about the scope of each type of voucher and, in particular, the criteria and limitations for product undesignated vouchers.
Retrieved 22 November 2023. ^ “Jaypirca Product information” Union Register of medicinal products. Jump up to: a b c d e f “FDA grants accelerated approval to pirtobrutinib for relapsed or refractory mantle cell lymphoma” FDA. Food and Drug Administration (FDA). 20 November 2023. Eli Lilly.
4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] The FDA rejected approval for gepirone in 2002 and 2004. [5]
This is the first approval under the previously announced collaboration between Nevakar and Endo for the development of five differentiated, sterile injectable products in the U.S. Additional information is available at www.nevakar.com. and Canada. Wilson
(212) 452-2793
E: lwilson@insitecony.com.
Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. “This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.”
The CMMC gathers information about metabolites that microbes produce so that researchers can gain a better understanding about their impact on human health and the environment. microbeMAAST: a taxonomically informed mass spectrometry search tool for microbial metabolomics data. Biochemical Pharmacology. Nature Microbiology.
3] Inavolisib was approved for medical use in the United States in October 2024. [3] 19] Society and culture Legal status In October 2024, the US Food and Drug Administration (FDA) approved inavolisib for the treatment of PIK3CA -mutant breast cancer based on the results from the INAVO120 trial. [3] 3 November 2006. cd-21-0072.
New Indication for Amgen’s Fifth FDA-approved Biosimilar. Now Approved to Treat All Available Rituxan ® Indications. For more information, visit www.amgenbiosimilars.com. Amgen (NASDAQ:AMGN) today announced that the U.S.
As of now, papers describing three of these machine learning tools have been published, in the Journal of Chemical Information and Modeling , Molecular Biology of the Cell , and Chemical Research in Toxicology. Journal of Chemical Information and Modeling. A fourth is in the works. Papers cited Seal S, et al. Online February 1, 2024.
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.
.–( BUSINESS WIRE )– Advanced Bionics (AB) , a global leader in cochlear implant technology, in collaboration with Phonak, a leading provider of life-changing hearing solutions, receives FDAapproval and announces it is bringing Marvel hearing technology to Advanced Bionics cochlear implant wearers. About Advanced Bionics.
As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options. Explain the FDAApproval Process Many patients are unaware of the rigorous approval process generic drugs must undergo.
BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. BOTOX ® (onabotulinumtoxinA) Important Information. IMPORTANT SAFETY INFORMATION. For more information refer to the Medication Guide or talk with your doctor. About BOTOX ®. Indications.
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