Drugs.com

JULY 2, 2024

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday. In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.

FDA Approval 290

FDA Approval Clinical Trials FDA Drugs 290

Drugs.com

MARCH 25, 2025

Food and Drug Administration has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women (weighing 40 kg or more) and children (12 years and older. TUESDAY, March 25, 2025 -- The U.S.

FDA Approval 253

FDA Approval FDA Treatment Drugs 253

BioPharma Drive: Drug Pricing

OCTOBER 23, 2023

The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.

FDA Approval 313

FDA Approval Vaccine FDA Disease 313

BioPharma Drive: Drug Pricing

AUGUST 12, 2024

The clearance of Yorvipath for hypoparathyroidism was some time coming for Ascendis, which had resubmitted after receiving a rejection last year.

FDA Approval 284

FDA Approval FDA Drugs 284

BioPharma Drive: Drug Pricing

JANUARY 30, 2025

Despite high demand for an option like Journavx, doctors fear the drug’s price could be a major hangup for insurers, potentially limiting patients’ ability to access it.

FDA Approval 359

FDA Approval Doctors Research FDA 359

Drugs.com

JANUARY 31, 2025

Food and Drug Administration (FDA) has approved Journavx, a new pain reliever without the risks of addiction or overdose linked to drugs like Vicodin and OxyContin.The new pill, developed by Vertex Pharmaceuticals. FRIDAY, Jan. 31, 2025 -- The U.S.

FDA Approval 246

FDA Approval FDA Pharmaceuticals Drugs 246

BioPharma Drive: Drug Pricing

MARCH 14, 2024

Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.

FDA Approval 326

FDA Approval FDA Drugs Disease 326

Drugs.com

FEBRUARY 4, 2025

Food and Drug Administration (FDA) has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step forward in cross-species transplantation.Two. TUESDAY, Feb. 4, 2025 -- The U.S.

Clinical Trials 244

Clinical Trials FDA Approval FDA Trials 244

Drugs.com

APRIL 25, 2024

Food and Drug Administration on Wednesday approved Pivya (pivmecillinam) to. THURSDAY, April 25, 2024 -- As many patients already know, urinary tract infections (UTIs) can recur despite the use of antibiotics. So, it's welcome news that the U.S.

FDA Approval 280

FDA Approval FDA Drugs 280

Drugs.com

MAY 15, 2024

Food and Drug Administration has approved a kit that will allow women to collect their own vaginal sample for HPV screening, a move that could increase early detection in those at risk for cervical cancer. WEDNESDAY, May 15, 2024 -- The U.S.

FDA Approval 290

FDA Approval FDA Drugs 290

Drugs.com

JULY 2, 2024

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday.In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.

FDA Approval 264

FDA Approval Clinical Trials FDA Drugs 264

Drugs.com

FEBRUARY 18, 2025

Food and Drug Administration has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for active immunization against invasive meningococcal disease (IMD), according to a press release from. TUESDAY, Feb. 18, 2025 -- The U.S.

FDA Approval 274

FDA Approval Vaccine FDA Disease 274

Drugs.com

MARCH 6, 2025

Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.TNKase is delivered as a single five-second. THURSDAY, March 6, 2025 -- The U.S.

FDA Approval 261

FDA Approval FDA Treatment Drugs 261

Drugs.com

MARCH 19, 2024

Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs. DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval.

FDA Approval 279

FDA Approval FDA Drugs 279

BioPharma Drive: Drug Pricing

NOVEMBER 11, 2024

Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the brand name Aucatzyl.

FDA Approval 285

FDA Approval FDA Therapies 285

Chemical Biology and Drug Design

FEBRUARY 6, 2025

This work presents a comprehensive analysis of oxygen atoms in approved drugs, aiming to streamline drug design and discovery efforts. The study examines the frequency, distribution, prevalence, and diversity of oxygen atoms in a dataset of 2049 small molecules approved by the FDA and other agencies.

FDA Approval 100

FDA Approval FDA Small Molecule Pharmacokinetics 100

Drugs.com

MARCH 19, 2024

Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs.DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval.

FDA Approval 264

FDA Approval FDA Drugs 264

Drugs.com

JANUARY 22, 2025

Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants. WEDNESDAY, Jan. 22, 2025 -- The U.S.

FDA Approval 278

FDA Approval Treatment FDA Drugs 278

Drugs.com

SEPTEMBER 20, 2024

Food and Drug Administration on Friday approved FluMist nasal spray as the first influenza vaccine that can be. FRIDAY, Sept. 20, 2024 -- The days of waiting for a flu shot at your doctor's office or local pharmacy may be over: The U.S.

FDA Approval 290

FDA Approval Vaccine Pharmacy Doctors 290

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

APRIL 25, 2024

Food and Drug Administration on Wednesday approved Pivya (pivmecillinam) to. THURSDAY, April 25, 2024 -- As many patients already know, urinary tract infections (UTIs) can recur despite the use of antibiotics.So, it's welcome news that the U.S.

FDA Approval 237

FDA Approval FDA Drugs 237

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

Drugs.com

APRIL 2, 2025

Food and Drug Administration has approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with. WEDNESDAY, April 2, 2025 -- The U.S.

FDA Approval 257

FDA Approval FDA Drugs 257

BioPharma Drive: Drug Pricing

OCTOBER 13, 2023

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

FDA Approval 293

FDA Approval FDA Pharmaceuticals Marketing 293

Drugs.com

JULY 6, 2023

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. THURSDAY, July 6, 2023 -- The U.S.

FDA 278

FDA FDA Approval Drugs 278

BioPharma Drive: Drug Pricing

DECEMBER 6, 2023

The pharma is developing Fabhalta, now cleared for paroxysmal nocturnal hemoglobinuria, for several other rare, complement-driven diseases.

FDA Approval 301

FDA Approval Disease FDA Drugs 301

BioPharma Drive: Drug Pricing

MARCH 15, 2024

The company expects initial uptake of Rezdiffra, which costs $47,400 per year, to be slow as doctors and insurers establish the protocols needed to find patients eligible for treatment.

FDA Approval 313

FDA Approval Doctors FDA Treatment 313

BioPharma Drive: Drug Pricing

MARCH 28, 2024

The agency gave Akebia’s drug an OK after receiving more safety data, but imposed a strict boxed warning for its use that may limit uptake.

FDA Approval 284

FDA Approval FDA Drugs 284

Drugs.com

MARCH 24, 2025

Food and Drug Administration has approved Tremfya (guselkumab) for adult patients with moderately to severely active Crohn disease.This approval is the fourth indication for this dual-acting interleukin-23. MONDAY, March 24, 2025 -- The U.S.

FDA Approval 227

FDA Approval Disease FDA Drugs 227

Drugs.com

SEPTEMBER 27, 2024

27, 2024 -- The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. FRIDAY, Sept. Food and Drug Administration.Cobenfy (xanomeline/trospium chloride) could bring patients what they've.

FDA Approval 246

FDA Approval FDA Drugs 246

Drugs.com

SEPTEMBER 20, 2024

Food and Drug Administration on Friday approved FluMist nasal spray as the first influenza vaccine that can be. FRIDAY, Sept. 20, 2024 -- The days of waiting for a flu shot at your doctor's office or local pharmacy may be over: The U.S.

FDA Approval 279

FDA Approval Vaccine Pharmacy Doctors 279

BioPharma Drive: Drug Pricing

MARCH 26, 2024

Merck is couting on Winrevair, which it acquired by buying Acceleron Pharma, to help soften the blow when Keytruda loses patent protection later this decade.

FDA Approval 292

FDA Approval Disease FDA Drugs 292

Drugs.com

SEPTEMBER 27, 2024

27, 2024 -- The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. FRIDAY, Sept. Food and Drug Administration. Cobenfy (xanomeline/trospium chloride) could bring patients what they've.

FDA Approval 264

FDA Approval FDA Drugs 264

Drugs.com

NOVEMBER 17, 2023

16, 2023 -- The first home test for chlamydia and gonorrhea will soon hit the market, following its approval Wednesday by the U.S. THURSDAY, Nov. Food and Drug Administration. People will be able to buy the Simple 2 Test over-the-counter at a.

FDA Approval 279

FDA Approval FDA Marketing Drugs 279

Drugs.com

JANUARY 18, 2024

18, 2024 (HealthDay news) -- The first medical device powered by artificial intelligence and designed to help doctors catch skin cancer has been approved by the U.S. THURSDAY, Jan. Food and Drug Administration.Although not meant to be used as a.

FDA Approval 278

FDA Approval Doctors FDA Drugs 278

Drugs.com

NOVEMBER 10, 2023

10, 2023 (Healthday News) -- The first vaccine to prevent infection with the chikungunya virus was approved by the U.S. The single-dose shot, known as Ixchiq, is approved for adults who are at. FRIDAY, Nov. Food and Drug Administration on Thursday.

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Virus FDA Approval Vaccine FDA 264