Drugs.com

JUNE 26, 2023

MONDAY, June 26, 2023 -- The U.S. Food and Drug Administration has approved Talzenna (talazoparib) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The approval was.

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FDA Approval FDA Drugs 246

Drugs.com

AUGUST 17, 2023

17, 2023 -- The U.S. 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.

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FDA Approval FDA Treatment Drugs 246

Drugs.com

DECEMBER 21, 2023

21, 2023 -- A newly approved test can determine whether a person has a genetically driven risk of becoming addicted to opioids. THURSDAY, Dec. The AvertD test, the first of its kind, uses a DNA sample swabbed from a patient’s cheek to.

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Drugs.com

JUNE 23, 2023

FRIDAY, June 23, 2023 -- The U.S. 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:

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FDA Approval Therapies FDA Treatment 246

Drugs.com

JULY 13, 2023

THURSDAY, July 13, 2023 -- The U.S. Food and Drug Administration on Thursday approved the nation's first over-the-counter birth control pill, a move that will likely pave the way for far greater access to contraception for Americans. Women will be.

FDA Approval 246

FDA Approval FDA Drugs 246

Drugs.com

AUGUST 3, 2023

3, 2023 -- The U.S. 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. We know naloxone is a powerful tool to.

FDA Approval 246

FDA Approval FDA Treatment Drugs 246

Drugs.com

AUGUST 9, 2023

9, 2023 -- The U.S. 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.

FDA Approval 246

FDA Approval FDA Treatment Drugs 246

Drugs.com

JUNE 13, 2023

TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option of using a topical gel to treat the condition. Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a.

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FDA Approval FDA Production Marketing 246

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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FDA Approval FDA Treatment Drugs 245

Drugs.com

JULY 28, 2023

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

FDA Approval 189

FDA Approval FDA Treatment Drugs 189

Drugs.com

JULY 6, 2023

THURSDAY, July 6, 2023 -- The U.S. Food and Drug Administration on Thursday gave full approval to the Alzheimer's drug Leqembi, clearing the way for insurance coverage of the pricey drug. “The full FDA approval will open the floodgates for.

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FDA FDA Approval Drugs 278

Drugs.com

JUNE 30, 2023

FRIDAY, June 30, 2023 -- The U.S. 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 million for a single.

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FDA Approval Therapies FDA Treatment 214

Collaborative Drug

MARCH 1, 2024

FDA Approved 55 New Molecular Entities in 2023 Can Ancient Skeletons Give Clues to Modern Medical Mysteries? and More

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FDA Approval FDA Drugs 262

Drugs.com

JUNE 27, 2023

TUESDAY, June 27, 2023 -- The U.S. Food and Drug Administration has approved Litfulo (ritlecitinib) for adults and adolescents aged 12 years and older with severe alopecia areata at a recommended dose of 50 mg. Approval of Litfulo was granted to.

FDA Approval 189

FDA Approval FDA Drugs 189

Drugs.com

NOVEMBER 9, 2023

8, 2023 -- A second injectable diabetes drug has been approved for weight loss in overweight and obese adults, the U.S. WEDNESDAY, Nov. Food and Drug Administration announced Wednesday. The weight-loss drug Zepbound contains the same active.

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FDA Approval FDA Drugs 213

Crown Bioscience

JUNE 6, 2024

In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023.

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FDA Approval FDA Drugs Research 105

Drugs.com

AUGUST 22, 2023

22, 2023 -- Women may soon have a vaccine they can take during a pregnancy to help protect their newborn from respiratory syncytial virus (RSV), following U.S. Food and Drug Administration approval of the shot, called Abrysvo, on. TUESDAY, Aug.

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Vaccine FDA Approval Virus FDA 189

Drugs.com

JUNE 13, 2023

TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option of using a topical gel to treat the condition. Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a.

FDA Approval 203

FDA Approval FDA Production Marketing 203

Drugs.com

AUGUST 22, 2023

22, 2023 -- Women may soon have a vaccine they can take during a pregnancy to help protect their newborn from respiratory syncytial virus (RSV), following U.S. Food and Drug Administration approval of the shot, called Abrysvo, on. TUESDAY, Aug.

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Vaccine FDA Approval Virus FDA 189

BioPharma Drive: Drug Pricing

FEBRUARY 24, 2025

Mirum gained the drug, which it will sell as Ctexli for adults with cerebrotendinous xanthomatosis, in a 2023 deal with Travere Therapeutics.

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FDA Approval Disease FDA Drugs 147

Drugs.com

JUNE 21, 2023

WEDNESDAY, June 21, 2023 -- The U.S. Food and Drug Administration on Tuesday approved two drugs that have been used in adults with type 2 diabetes for years for use in children aged 10 and up. The approvals of Jardiance (empagliflozin) and Synjardy.

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FDA Approval FDA Drugs 189

Drugs.com

OCTOBER 18, 2023

17, 2023 -- The U.S. Food and Drug Administration approved Velsipity (etrasimod) for adults with moderately to severely active ulcerative colitis (UC). The approval was based on results from the ELEVATE UC phase 3 registrational. TUESDAY, Oct.

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FDA Approval FDA Drugs 162

Drugs.com

JULY 24, 2023

MONDAY, July 24, 2023 -- The U.S. 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). Ycanth uses a.

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FDA Approval Treatment FDA Drugs 130

Drugs.com

JULY 13, 2023

THURSDAY, July 13, 2023 -- The U.S. Food and Drug Administration on Thursday approved the nation's first over-the-counter birth control pill, a move that will likely pave the way for far greater access to contraception for Americans. Women will be.

FDA Approval 130

FDA Approval FDA Drugs 130

New Drug Approvals

MAY 17, 2025

3] Tofersen was approved for medical use in the United States in April 2023, [3] [6] and in the European Union in May 2024. [4] 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] 25 April 2023. Archived from the original on 8 May 2023. Retrieved 10 June 2023.

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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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Drugs.com

JUNE 7, 2023

TUESDAY, June 6, 2023 -- The U.S. Food and Drug Administration approved Lynparza (olaparib) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated, metastatic, castration-resistant.

FDA Approval 130

FDA Approval FDA Drugs 130

Drugs.com

JUNE 13, 2023

TUESDAY, June 13, 2023 -- Men with erectile dysfunction will now have the option of using a topical gel to treat the condition. Food and Drug Administration has approved over-the-counter marketing for the product, called Eroxon, as a.

FDA Approval 130

FDA Approval FDA Production Marketing 130

Drugs.com

JUNE 21, 2023

WEDNESDAY, June 21, 2023 -- The U.S. Food and Drug Administration on Tuesday approved two drugs that have been used in adults with type 2 diabetes for years for use in children aged 10 and up. The approvals of Jardiance (empagliflozin) and Synjardy.

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FDA Approval FDA Drugs 130

The Pharma Data

JUNE 16, 2025

FDA Approves ANDEMBRY (garadacimab-gxii) The First Once-Monthly Prophylactic HAE Therapy Targeting Factor XIIa CSL a leading biotechnology company with a strong track record of developing innovative medicines for patients with rare and serious disorders, today announced that the U.S. when directly comparing ANDEMBRY to placebo.

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FDA Approval Treatment FDA Therapies 40

Drugs.com

AUGUST 2, 2023

2, 2023 -- All eyes are on the U.S. Food and Drug Administration this week as the agency weighs approval of a new pill that may quickly treat and ease severe postpartum depression. Approval of the drug could help millions of women. WEDNESDAY, Aug.

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Drugs.com

AUGUST 2, 2023

2, 2023 -- All eyes are on the U.S. Food and Drug Administration this week as the agency weighs approval of a new pill that may quickly treat and ease severe postpartum depression. Approval of the drug could help millions of women. WEDNESDAY, Aug.

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FDA Approval Trials FDA Drugs 130

New Drug Approvals

JUNE 11, 2025

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] Retrieved 28 September 2023. Kirsch I (2014).

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Metabolite Tales Blog

APRIL 10, 2024

Table 1: Small molecule drugs approved by the FDA in 2023 with reported involvement of phase II mechanisms In vitro : In vivo differences Incubation of the SGLT2 (sodium-glucose co-transporter-2) inhibitor bexagliflozin in human liver microsomes points to metabolism through both oxidation and glucuronidation to 6 main metabolites.

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Small Molecule FDA Approval FDA Pharmacokinetics 59

Drugs.com

JUNE 30, 2023

FRIDAY, June 30, 2023 -- The U.S. 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.

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PLOS: DNA Science

MARCH 28, 2024

Results from the study that led to the FDA approval appeared in The Lancet Neurology in April 2024 with commentary. In 2023, two gene-based treatments became available. The post FDA Approves Duvystat, New Oral Treatment for Duchenne Muscular Dystrophy (DMD) appeared first on DNA Science.

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FDA Approval Treatment FDA DNA 96

Drugs.com

JULY 17, 2023

MONDAY, July 17, 2023 (HealthDay Now) -- Parents now have a new long-acting drug to protect their children against respiratory syncytial virus (RSV), a common germ that hospitalizes as many as 3% of children under the age of 1 in the United States.

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