BioPharma Drive: Drug Pricing

AUGUST 13, 2024

Nemluvio is now cleared for adults with the chronic itching condition prurigo nodularis, making it a competitor to Sanofi and Regeneron’s Dupixent.

FDA Approval 286

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JULY 29, 2024

Food and Drug Administration on Monday approved a new blood test that can spot colon cancer.In late May, an FDA advisory panel had voted 7-2 that the benefits outweigh the risks when using the Guardant Health's. MONDAY, July 29, 2024 -- The U.S.

FDA Approval 299

FDA Approval FDA Drugs 299

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

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 321

FDA Approval FDA Drugs Disease 321

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 306

FDA Approval Vaccine FDA Disease 306

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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 291

FDA Approval FDA Drugs 291

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 278

FDA Approval FDA Drugs 278

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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.

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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.

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FDA Approval Vaccine FDA Disease 276

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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 262

FDA Approval FDA Treatment Drugs 262

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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. FRIDAY, Jan. 31, 2025 -- The U.S. The new pill, developed by Vertex.

FDA Approval 307

FDA Approval FDA Drugs 307

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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 279

FDA Approval Treatment FDA Drugs 279

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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 291

FDA Approval Vaccine Pharmacy Doctors 291

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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 267

FDA Approval FDA Treatment Drugs 267

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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 278

FDA Approval Disease FDA Treatment 278

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 278

FDA Approval FDA Therapies 278

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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.

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FDA Approval Therapies FDA Treatment 313

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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 299

FDA Approval FDA Treatment Drugs 299

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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 281

FDA Approval FDA Drugs 281

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 286

FDA Approval FDA Pharmaceuticals Marketing 286

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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 280

FDA Approval Vaccine Pharmacy Doctors 280

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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

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 306

FDA Approval Doctors FDA Treatment 306

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AUGUST 30, 2023

August 28, 2023 -- FDA has approved several first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/hyperactivity disorder (ADHD) in patients six years and older and moderate to severe binge-eating.

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FDA Approval FDA 246

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 294

FDA Approval Disease FDA Drugs 294

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 265

FDA Approval FDA Drugs 265

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 280

FDA Approval FDA Marketing Drugs 280

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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 279

FDA Approval Doctors FDA Drugs 279

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 278

FDA Approval FDA Drugs 278

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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 265

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FEBRUARY 5, 2025

Food and Drug Administration has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. The approval was based on the results of three phase 3 trials of. WEDNESDAY, Feb. 5, 2025 -- The U.S.

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FDA Approval Treatment FDA Trials 261

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 285

FDA Approval Disease FDA Drugs 285

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

FDA Approval 246

FDA Approval Therapies FDA Treatment 246

BioPharma Drive: Drug Pricing

NOVEMBER 16, 2023

Acquired via a $4 billion biotech buyout, Augtyro is one of an array of new products the pharma hopes will offset patent expirations for current top sellers.

FDA Approval 267

FDA Approval FDA Production Drugs 267

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 312

FDA Approval Laboratories FDA Drugs 312

BioPharma Drive: Drug Pricing

AUGUST 29, 2023

A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.

FDA Approval 286

FDA Approval Disease FDA Marketing 286