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.

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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.

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FDA Approval Clinical Trials FDA Drugs 116

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.

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FDA Approval FDA Drugs 119

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.

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FDA Approval FDA Drugs 105

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.

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FDA Approval FDA 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.

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Drugs.com

SEPTEMBER 11, 2023

MONDAY, Sept. 11, 2023 -- The U.S. Food and Drug Administration on Monday gave the green light to new COVID boosters for Americans, setting the stage for the updated vaccines to become available within days. The COVID-19 shots from Pfizer and.

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FDA Approval FDA Vaccine Drugs 119

Metabolite Tales Blog

APRIL 10, 2024

link] The post Metabolism of 2023 FDA Approved Small Molecules – PART 2 appeared first on Hypha Discovery. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023; 62(12):1765-1779.

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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.

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FDA Approval FDA Drugs 95

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.

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FDA Approval FDA Drugs Disease 128

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.

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FDA Approval FDA Drugs 116

BioPharma Drive: Drug Pricing

OCTOBER 16, 2024

Alongside immunotherapy or chemo, the wearable device helped patients live longer in a trial, though the results are somewhat controversial.

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FDA Approval FDA Trials 101

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.

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FDA Approval FDA Drugs 112

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.

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FDA Approval FDA Drugs 98

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.

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FDA Approval FDA Drugs 116

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

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FDA Approval FDA Drugs Pharmaceuticals 94

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.

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FDA Approval FDA 98

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.

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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.

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FDA Approval FDA Vaccine 124

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.

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FDA Approval FDA Drugs 112

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.

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FDA Approval Vaccine FDA Disease 122

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.

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FDA Approval FDA Doctors Drugs 111

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.

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FDA Approval FDA Drugs 111

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 105

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.

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FDA Approval Doctors FDA Treatment 122

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.

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FDA Approval Therapies FDA Treatment 124

BioPharma Drive: Drug Pricing

JUNE 29, 2023

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

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FDA Approval Therapies FDA 133

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.

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FDA Approval Disease FDA Drugs 114

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. That requirement would only be fulfilled if FDA agreed to such a change. But we digress. And indeed, after Pliva v.

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FDA Approval FDA Production Drugs 40

Drugs.com

MARCH 15, 2024

FRIDAY, March 15, 2024 -- Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday.The condition is.

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FDA Approval Disease FDA Drugs 98

Drugs.com

AUGUST 9, 2024

Food and Drug Administration on Friday announced that it has approved neffy, the first. FRIDAY, Aug. 9, 2024 -- People who are nervous about administering a rescue shot for anaphylaxis finally have a new alternative in a nasal spray.The U.S.

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FDA Approval FDA Drugs 98

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.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. We hope it was a useful two-parter! We’re looking forward to the next crop!

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done.

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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.

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FDA Approval Treatment FDA 67

Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. References Iversen et al., Front Pharmacol.,

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Small Molecule FDA Approval FDA Drugs 52

Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. link] [19] FDA prescribing information for zilucoplan.

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