BioPharma Drive: Drug Pricing

SEPTEMBER 11, 2023

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

FDA Approval 128

FDA Approval FDA Vaccine 128

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 116

FDA Approval Clinical Trials FDA Drugs 116

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 116

FDA Approval FDA Drugs 116

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 126

FDA Approval Vaccine FDA Disease 126

Drugs.com

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 119

FDA Approval FDA Drugs 119

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 126

FDA Approval Doctors FDA Treatment 126

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 112

FDA Approval FDA Drugs 112

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 116

FDA Approval FDA Therapies 116

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 116

FDA Approval FDA Drugs 116

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 116

FDA Approval FDA Drugs 116

Drugs.com

MARCH 8, 2024

FRIDAY, March 8, 2024 -- Wegovy (semaglutide), the weight-loss version of blockbuster diabetes drug Ozempic, was approved on Friday by the U.S. Food and Drug Administration to help prevent heart attack, stroke and heart death.“Wegovy Wegovy is now the.

FDA Approval 116

FDA Approval FDA Drugs 116

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 105

FDA Approval Clinical Trials FDA Drugs 105

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 119

FDA Approval Disease FDA Drugs 119

Drugs.com

MAY 17, 2024

Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer. FRIDAY, MAY 17, 2024 -- The U.S. Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other.

FDA Approval 112

FDA Approval FDA Drugs 112

Drugs.com

JULY 5, 2023

WEDNESDAY, July 5, 2023 -- A new blood test approved by the U.S. Food and Drug Administration can predict imminent preeclampsia, helping pregnant women who are at risk for this severe and sometimes deadly form of high blood pressure. The test can.

FDA Approval 134

FDA Approval FDA Drugs 134

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. BINGHAMTON, N.Y.

FDA Approval 83

FDA Approval FDA Disease Pharmacy 83

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 111

FDA Approval FDA Doctors Drugs 111

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 116

FDA Approval Vaccine Pharmacy Doctors 116

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 124

FDA Approval Therapies FDA Treatment 124

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 95

FDA Approval FDA Drugs 95

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 119

FDA Approval FDA Pharmaceuticals Marketing 119

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 119

FDA Approval FDA Treatment Drugs 119

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 122

FDA Approval Disease FDA Drugs 122

Drug Patent Watch

JULY 24, 2024

In the high-stakes world of pharmaceuticals, generic drugs have become the unsung heroes of healthcare accessibility. These cost-effective alternatives to […] Source

FDA Approval 105

FDA Approval FDA Drugs Pharmaceuticals 105

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 98

FDA Approval FDA Drugs 98

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 111

FDA Approval Vaccine Pharmacy Doctors 111

Drugs.com

MAY 17, 2024

Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer. FRIDAY, MAY 17, 2024 -- The U.S. Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all other.

FDA Approval 98

FDA Approval FDA Drugs 98

Drugs.com

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.

FDA Approval 98

FDA Approval FDA 98

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 105

FDA Approval FDA Drugs 105

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 111

FDA Approval FDA Production Drugs 111

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 111

FDA Approval FDA Marketing Drugs 111

Drugs.com

SEPTEMBER 7, 2023

Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News. THURSDAY, Sept. 7, 2023 -- New COVID-19 booster shots could soon pass the needed hurdles for vaccinations to begin next week. Sources familiar with U.S.

FDA Approval 116

FDA Approval FDA Vaccine Drugs 116

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.

Virus 105

Virus FDA Approval Vaccine FDA 105

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 113

FDA Approval Therapies FDA Treatment 113

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 119

FDA Approval Disease FDA Marketing 119

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 128

FDA Approval Laboratories FDA Drugs 128

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. TUESDAY, March 19, 2024 -- The U.S.

FDA Approval 111

FDA Approval FDA Drugs 111