Drugs.com

FEBRUARY 6, 2025

Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in patients with. THURSDAY, Feb. 6, 2025 -- The U.S.

FDA Approval 277

FDA Approval Disease FDA Treatment 277

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. FRIDAY, Dec. 8, 2023 -- The U.S. Casgevy, developed by Vertex.

FDA Approval 312

FDA Approval Therapies FDA Treatment 312

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.

FDA Approval 298

FDA Approval FDA Treatment Drugs 298

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.

FDA Approval 320

FDA Approval Laboratories FDA Drugs 320

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.

FDA 331

FDA FDA Approval Clinical Trials Therapies 331

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.

FDA Approval 278

FDA Approval Therapies FDA Treatment 278

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.,

FDA Approval 182

FDA Approval Treatment FDA Therapies 182

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.

FDA Approval 246

FDA Approval Therapies FDA Treatment 246

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.

FDA Approval 182

FDA Approval FDA Treatment Drugs 182

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.

FDA Approval 283

FDA Approval Therapies FDA Treatment 283

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.

FDA Approval 246

FDA Approval Therapies FDA Treatment 246

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.

FDA Approval 246

FDA Approval FDA Treatment Drugs 246

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.

FDA Approval 277

FDA Approval Therapies FDA Treatment 277

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.

FDA Approval 237

FDA Approval FDA Treatment Drugs 237

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.

FDA Approval 246

FDA Approval FDA Treatment Drugs 246

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.

FDA Approval 147

FDA Approval Treatment FDA Therapies 147

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.

FDA Approval 246

FDA Approval FDA Treatment Drugs 246

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.

FDA Approval 189

FDA Approval FDA Treatment Drugs 189

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.

FDA Approval 245

FDA Approval FDA Treatment Drugs 245

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.

FDA Approval 214

FDA Approval Therapies FDA Treatment 214

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.

FDA Approval 130

FDA Approval FDA Treatment Drugs 130

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.

FDA Approval 130

FDA Approval Treatment FDA Drugs 130

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.

FDA Approval 130

FDA Approval FDA Treatment Drugs 130

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.

FDA Approval 162

FDA Approval Disease FDA Treatment 162

PLOS: DNA Science

MARCH 28, 2024

FDA classifies it as a “nonsteroidal treatment” – not a gene therapy, but it affects gene expression. Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary. A gene-based treatment would have to alter many cells to exert a noticeable effect.

FDA Approval 97

FDA Approval Treatment FDA DNA 97

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.

FDA Approval 130

FDA Approval FDA Treatment Drugs 130

Drugs.com

SEPTEMBER 10, 2023

September 8, 2023 -- Lotronex (alosetron hydrochloride) and approved generics are FDA approved for the treatment of irritable bowel syndrome in women whose predominant bowel symptom is diarrhea. Although safety risks for Lotronex (alosetron.

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FDA FDA Approval Treatment 162

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.

FDA Approval 83

FDA Approval FDA Disease Pharmacy 83

SCIENMAG: Medicine & Health

FEBRUARY 9, 2024

CLEVELAND—University Hospitals (UH) Brain Health & Memory Center is now treating patients with LEQEMBI® (lecanemab), a Food and Drug Administration-approved medication for the treatment of Alzheimer’s disease.

Hospitals 79

Hospitals FDA Approval Treatment Disease 79

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.

Treatment 85

Treatment FDA Approval FDA Drugs 85

BioPharma Drive: Drug Pricing

AUGUST 4, 2023

The treatment, which won FDA approval in July, is expected to be available by the start of the typical RSV season this fall.

FDA Approval 130

FDA Approval FDA Treatment 130

Drugs.com

JUNE 30, 2023

Food and Drug Administration on Thursday approved a costly single-dose gene therapy for patients with severe hemophilia A, a life-threatening hereditary bleeding disorder. The treatment is not cheap: Roctavian will.

FDA Approval 100

FDA Approval Therapies FDA Treatment 100

BioPharma Drive: Drug Pricing

AUGUST 2, 2023

The company is discussing various payment models for its sickle cell treatment with government and commercial insurers ahead of an FDA approval decision later this year.

FDA Approval 130

FDA Approval Therapies Government FDA 130

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.

FDA Approval 52

FDA Approval FDA Disease Treatment 52

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.

FDA Approval 52

FDA Approval FDA Treatment Vaccine 52

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.

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 52

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.

FDA Approval 52

FDA Approval Treatment FDA Trials 52