Drugs.com

FEBRUARY 19, 2024

Food and Drug Administration has approved a novel treatment for advanced melanoma, the most deadly form of skin cancer. becomes the first cellular therapy approved to. MONDAY, Feb. 19, 2024 -- The U.S. Amtagvi, made by Iovance Biotherapeutics Inc.,

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Drugs.com

JUNE 14, 2023

Food and Drug Administration approved Linzess (linaclotide) as a once-daily treatment for pediatric patients ages 6 to 17 years with functional constipation. The approval was based on data from 328 participants. WEDNESDAY, June 14, 2023 -- The U.S.

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Drugs.com

FEBRUARY 15, 2024

Food and Drug Administration (FDA) on Wednesday approved the first treatment for severe frostbite. THURSDAY, Feb. 15, 2024 -- The U.S. Known as Aurlumyn (iloprost), the injected medication lowers the risk of finger or toe amputation in cases of.

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BioPharma Drive: Drug Pricing

SEPTEMBER 11, 2023

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

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BioPharma Drive: Drug Pricing

FEBRUARY 21, 2024

One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.

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SCIENMAG: Medicine & Health

OCTOBER 31, 2023

. — A new drug developed by professors from the School of Pharmacy and Pharmaceutical Sciences at Binghamton University has received Food and Drug Administration (FDA) approval for the treatment of patients with Duchenne muscular dystrophy (DMD), a common genetic disease that mostly affects young boys.

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BioPharma Drive: Drug Pricing

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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SCIENMAG: Medicine & Health

DECEMBER 14, 2023

In the fatal world of opioid use disorder (OUD), pharmacotherapy, or using a prescribed medication to treat drug dependence, has emerged as the gold standard of treatment. Among the trio of FDA-approved medications to treat OUD, buprenorphine is the newest highly effective drug that can suppress and reduce cravings for opioids.

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Drugs.com

JUNE 23, 2023

Food and Drug Administration on Thursday approved the drug Elevidys, the first gene therapy for the treatment of children with Duchenne muscular dystrophy (DMD). The groundbreaking treatment will not be cheap: FRIDAY, June 23, 2023 -- The U.S.

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Drugs.com

DECEMBER 8, 2023

Food and Drug Administration on Friday approved two milestone gene therapies for sickle cell disease, including the first treatment ever approved that uses gene-editing technology.Casgevy, developed by Vertex. FRIDAY, Dec. 8, 2023 -- The U.S.

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Drugs.com

FEBRUARY 19, 2024

Food and Drug Administration has approved a novel treatment for advanced melanoma, the most deadly form of skin cancer.Amtagvi, made by Iovance Biotherapeutics Inc., becomes the first cellular therapy approved to. MONDAY, Feb. 19, 2024 -- The U.S.

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Drugs.com

JUNE 23, 2023

Food and Drug Administration on Thursday approved the drug Elevidys, the first gene therapy for the treatment of children with Duchenne muscular dystrophy (DMD). The groundbreaking treatment will not be cheap: FRIDAY, June 23, 2023 -- The U.S.

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Drugs.com

AUGUST 17, 2023

Food & Drug Administration has approved Akeega (niraparib and abiraterone acetate) for the treatment of BRCA-positive metastatic castration-resistant prostate cancer. The approval makes Akeega the first and. THURSDAY, Aug. 17, 2023 -- The U.S.

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BioPharma Drive: Drug Pricing

JUNE 30, 2023

The agency granted a long-awaited clearance on Thursday, but unexpected aspects of the hemophilia treatment’s label had some investors worried about its commercial prospects.

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BioPharma Drive: Drug Pricing

JULY 17, 2023

Developers AstraZeneca and Sanofi expect to make the preventive antibody treatment, called Beyfortus, available ahead of the upcoming cold season.

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The Pharma Data

AUGUST 9, 2021

The effectiveness of Nexviazyme for the treatment of Pompe disease was demonstrated in a study of 100 patients who were randomized to take Nexviazyme or another FDA-approved enzyme replacement therapy for Pompe disease. Treatment with Nexviazyme improved lung function similar to the improvement seen with the other therapy.

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The Pharma Data

APRIL 26, 2022

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population. director of the FDA’s Center for Drug Evaluation and Research.

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Drugs.com

AUGUST 3, 2023

Food and Drug Administration has approved RiVive, an over-the-counter (OTC) naloxone hydrochloride nasal spray for emergency treatment of known or suspected opioid overdose. "We THURSDAY, Aug. 3, 2023 -- The U.S. We know naloxone is a powerful tool to.

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Drugs.com

AUGUST 9, 2023

Food and Drug Administration has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to age-related macular degeneration. The approval was based on two. WEDNESDAY, Aug. 9, 2023 -- The U.S.

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Drugs.com

FEBRUARY 15, 2024

Food and Drug Administration (FDA) on Wednesday approved the first treatment for severe frostbite.Known as Aurlumyn (iloprost), the injected medication lowers the risk of finger or toe amputation in cases of. THURSDAY, Feb. 15, 2024 -- The U.S.

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The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy.

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The Pharma Data

OCTOBER 29, 2021

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. The blessing of Scemblix may offer stopgap to cases by addressing gaps in CML care.” Scemblix nearly doubled the MMR ratevs.

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Drugs.com

JULY 28, 2023

Food and Drug Administration has approved Xdemvy (lotilaner ophthalmic solution) 0.25 percent for the treatment of Demodex blepharitis, caused by Demodex mites. The approval was based on results from two. FRIDAY, July 28, 2023 -- The U.S.

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Drugs.com

JULY 18, 2023

TUESDAY, July 18, 2023 -- People living with the pain, bloody diarrhea and sometimes urgent need to use the toilet that comes with ulcerative colitis may soon have a new treatment option that’s already been given the go-ahead in Europe.

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Drugs.com

JUNE 30, 2023

Food and Drug Administration on Thursday approved a costly single-dose gene therapy for patients with severe hemophilia A. The treatment, Roctavian (valoctocogene roxaparvovec), will cost $2.9 FRIDAY, June 30, 2023 -- The U.S. million for a single.

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Drug Target Review

JUNE 5, 2023

It also supports the argument for developing ZW171 for the treatment of other MLSN-expressing solid tumours. What is the significance of ZW191 demonstrating strong responses in FRα-low expressing PDX models for the treatment of oncology indications with lower levels of FRα?

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The Pharma Data

OCTOBER 8, 2021

Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S. director of the FDA’s Center for Biologics Evaluation and Research. Today, the U.S. Dosing is patient?customized,

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ASPET

JULY 2, 2024

While treatment with the FDA-approved β 2 -adrenergic receptor agonist, formoterol, improves various aspects of recovery post-SCI in vivo , its effects on cytokines, chemokines and neuropathic pain remain unknown. Finally, formoterol treatment decreased mechanical allodynia and thermal hyperalgesia post-SCI.

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Drugs.com

JANUARY 16, 2025

Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn disease in adults, according to a press release from Eli Lilly and Company.Omvoh targets. THURSDAY, Jan. 16, 2025 -- The U.S.

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Drugs.com

JULY 24, 2023

Food and Drug Administration has approved the topical solution Ycanth (cantharidin) for the treatment of molluscum contagiosum (molluscum) in adult and pediatric patients (aged 2 years and older). MONDAY, July 24, 2023 -- The U.S. Ycanth uses a.

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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, advancing the company’s commitment to personalised healthcare through tests that determine which patients are most likely to benefit from specific and targeted therapies. 3 PD-1 inhibitors can be effective treatment in cancers with MMR deficiency.

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Metabolite Tales Blog

APRIL 10, 2024

It is approved for treatment of severe alopecia areata in which inflammatory processes play a major role, with associated increased reactive oxygen species formation and reduced levels of GSH. link] The post Metabolism of 2023 FDA Approved Small Molecules – PART 2 appeared first on Hypha Discovery.

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The Pharma Data

AUGUST 7, 2021

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells. Nexviazyme is expected to be available in the U.S.

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FDA Law Blog: Drug Discovery

MARCH 26, 2024

Sasinowski — On March 21st, FDA announced the approval of the first nonsteroidal therapy for the treatment of Duchenne Muscular Dystrophy (DMD) (FDA press release available here ). The primary basis for approval, like other drugs for DMD, was based on a single placebo-controlled randomized trial. By Charles G.

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Drug Target Review

FEBRUARY 21, 2024

This is a time when several promising treatments – including mRNA vaccines, BiTE therapies and CAR-T cell therapy, are essentially in competition with each other – they all have a common goal of treating the same disease, but they are approaching the objective from different angles.

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The Pharma Data

MAY 19, 2023

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S.

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Drugs.com

DECEMBER 26, 2024

Food and Drug Administration (FDA) announced on Monday the approval of the first generic version of a daily injectable GLP-1 medicine for people living with Type 2 diabetes. THURSDAY, Dec. 26, (2024 HealthDay News) -- The U.S. Liraglutide, the.

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