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.,

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

The Pharma Data

NOVEMBER 2, 2020

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder.

FDA Approval 52

FDA Approval FDA Pharmaceutical Companies Therapies 52

Agency IQ

JANUARY 12, 2024

After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada. Fill out the form to read the full article.

FDA Approval 59

FDA Approval FDA Drugs Pharmaceuticals 59

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. It’s very exciting to see this treatment go from being an experimental therapy used at my daughter’s bedside to now being FDA approved. Related Articles: Danyelza (naxitamab-gqgk) FDA Approval History. NEW YORK, Nov. Source link.

FDA Approval 52

FDA Approval Treatment FDA Clinical Trials 52

The Pharma Data

DECEMBER 16, 2020

17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. We will now rapidly move to initiate our Phase 2 trial of Berubicin for adults with GBM and expect to begin enrolling patients in the first quarter of next year,” commented John Climaco , CEO of CNS Pharmaceuticals. About CNS Pharmaceuticals, Inc.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

The Pharma Data

NOVEMBER 27, 2020

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency. 27, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. With this approval, Imcivree becomes the first-ever FDA approved therapy for these rare genetic diseases of obesity.

FDA Approval 52

FDA Approval FDA Clinical Trials Therapies 52

Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceutical product.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies FDA Approval Production 52

The Pharma Data

DECEMBER 15, 2020

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp. Food and Drug Administration (FDA) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp. The FDA approval of Klisyri is a significant milestone for Athenex.

FDA Approval 52

FDA Approval Treatment FDA Therapies 52

FDA Law Blog: Biosimilars

OCTOBER 1, 2024

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. VANDA PHARMACEUTICALS, INC. VANDA PHARMACEUTICALS, INC. 24-270 VANDA PHARMACEUTICALS, INC. 23-5200 (D.C.

Government 59

Government FDA Pharmaceuticals FDA Approval 59

The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

FDA Approval 52

FDA Approval Therapies FDA Treatment 52

Advarra

JULY 27, 2022

As a pharmaceutical product makes its way through the lifecycle, there are often Food and Drug Administration (FDA) guidelines organizations should pay particular attention to. If your go-to-market strategy requires FDA approval, it may also require a prior approval supplement. Go-to-market Strategy.

Production 52

Production Pharmaceuticals FDA Approval FDA 52

The Pharma Data

DECEMBER 1, 2020

VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. ABOUT AURINIA.

Pharmaceuticals 52

Pharmaceuticals FDA Approval FDA Therapies 52

Drug Target Review

JANUARY 8, 2024

Jerry has over 30 years of experience in the biopharmaceutical industry and has been involved in the discovery, clinical development, and global commercialisation of more than a dozen FDA-approved drugs with multiple successful exits. a commercial stage pharmaceutical company. acquired by Teva Pharmaceuticals in 2014.

Science 145

Science Disease FDA Approval Clinical Trials 145

The Pharma Data

OCTOBER 21, 2020

Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation. Under an exclusive licensing agreement with Endo International’s (NASDAQ: ENDP) subsidiary, Endo Ventures Limited, Par Pharmaceuticals’ Sterile Products division will launch and distribute the product.

FDA Approval 40

FDA Approval FDA Pharmaceutical Companies Pharmaceuticals 40

The Pharma Data

APRIL 19, 2022

Food and Drug Administration (FDA) has approved commercial production at the company’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland. The site will produce Kite’s FDA approved CAR T-cell therapy used to treat blood cancer.

FDA Approval 52

FDA Approval Therapies FDA Hospitals 52

The Pharma Data

JANUARY 7, 2021

VICTORIA, British Columbia–( BUSINESS WIRE )– Aurinia Pharmaceuticals Inc. Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. ABOUT AURINIA.

Pharmaceuticals 52

Pharmaceuticals FDA Approval Clinical Trials FDA 52

New Drug Approvals

APRIL 25, 2025

3] Inavolisib was approved for medical use in the United States in October 2024. [3] 19] Society and culture Legal status In October 2024, the US Food and Drug Administration (FDA) approved inavolisib for the treatment of PIK3CA -mutant breast cancer based on the results from the INAVO120 trial. [3] 3 November 2006. PMC 8706051.

FDA 57

FDA FDA Approval Therapies Trials 57

The Pharma Data

AUGUST 31, 2020

Food and Drug Administration (FDA) approval for the cobas® HIV-1/HIV-2 Qualitative Test for use on the fully automated cobas® 6800/8800 Systems in the U.S. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Learn more now: www.cobas68008800.com.

FDA Approval 52

FDA Approval FDA Virus Disease 52

The Pharma Data

JULY 29, 2021

The FDA released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products. The FDA granted approval of Semglee (insulin glargine-yfgn) to Mylan Pharmaceuticals Inc. Source link: [link].

Biosimilars 52

Biosimilars Production FDA Approval FDA 52

DrugBank

DECEMBER 18, 2024

A new shift is occurring in the pharmaceutical industry, leading to a rapidly expanding field known as digital therapeutics (DTx). DTx interventions include sensor-equipped wearable devices, remote patient monitoring tools, and virtual reality platforms integrated with conventional pharmaceutical treatments.

Pharmaceuticals 52

Pharmaceuticals Pharmaceutical Companies Treatment Therapies 52

The Pharma Data

DECEMBER 3, 2020

BioCryst Pharmaceuticals, Inc. Food and Drug Administration (FDA) has approved ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and young patients 12 years and older. announced on Thursday that the U.S.

FDA Approval 52

FDA Approval Therapies FDA Trials 52

Drug Target Review

MARCH 12, 2024

Scientists from the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California San Diego have discovered thousands of bile acids. The study’s findings offer new insights into the biochemical language microbes use to influence distant organ systems, which could revolutionise the way researchers approach disease.

Disease 111

Disease Biochemical Pharmacology FDA Approval Pharmacy 111

New Drug Approvals

APRIL 18, 2025

2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2] Food and Drug Administration (FDA) (Press release).

FDA 62

FDA FDA Approval Drugs Trials 62

New Drug Approvals

APRIL 2, 2025

1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Food and Drug Administration (FDA).

FDA 62

FDA Therapies Trials Treatment 62

Pharmaceutical Development Group

DECEMBER 19, 2021

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products that improve the quality of life for their patients. In a FDA Pre-Submission that leads to FDA Approval, more does not equal better and more does not equal relevance to a specific Pharmaceutical Drug or Biologic Product.

FDA Approval 52

FDA Approval FDA Clinical Trials Drug Development 52

Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. Dr. Spanogle has taken scores of Regulated Life Science Products from discovery to approval and launch; and audited, identified, and remediated QMS deficiencies.

FDA 52

FDA FDA Approval Biosimilars Science 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

Amongst his accomplishments, Law360 considered the role James has played in leveraging little-used pathways to FDA approval for often first-ever drugs to treat rare diseases (e.g., James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list.

Science 81

Science FDA Approval FDA Drug Development 81

The Pharma Data

NOVEMBER 2, 2020

GW Pharmaceuticals hopes to bring its cannabis-based treatment for multiple sclerosis spasticity to the United States. Sativex is approved for use in parts of Europe for this indication. Justin Gover, chief executive officer of GW Pharmaceuticals, proclaimed his excitement about launching the Phase III study in the United States.

FDA Approval 52

FDA Approval Marketing FDA Drugs 52

The Pharma Data

JULY 8, 2021

is a leading global pharmaceutical company headquartered in Japan. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media – Twitter , LinkedIn , Facebook , YouTube. About Eisai Co.,

Clinical Trials 52

Clinical Trials FDA Approval Trials FDA 52

The Pharma Data

JANUARY 6, 2021

SK Chemicals’ life sciences business is dominated by pharmaceuticals and biologics and is aimed at providing comprehensive healthcare solutions that cover patient care from diagnosis to treatment and prevention.

FDA Approval 52

FDA Approval FDA Drugs Science 52

The Pharma Data

MAY 31, 2022

In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

DECEMBER 16, 2020

–( BUSINESS WIRE )– ANI Pharmaceuticals, Inc. , (“ANI” or the “Company”) (Nasdaq: ANIP) today announced U.S. Food and Drug Administration (FDA) approval and the launch of Aminocaproic Acid Tablets USP, 500mg. ANI Pharmaceuticals, Inc. BAUDETTE, Minn.–( The current annual U.S. earlier this year.

Pharmaceuticals 40

Pharmaceuticals FDA Approval Production Pharmaceutical Companies 40

New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] Rigel Pharmaceuticals. Hz, 1 H), 4.62−4.75

FDA Approval 52

FDA Approval FDA Treatment Pharmaceuticals 52

The Pharma Data

JANUARY 6, 2021

UNION therapeutics A/S is a privately held, clinical stage, pharmaceutical company dedicated to the development of novel treatments for inflammatory and infectious diseases. About UNION therapeutics A/S.

FDA Approval 52

FDA Approval FDA Clinical Development Treatment 52

The Pharma Data

DECEMBER 16, 2020

16, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

FDA Approval 52

FDA Approval Laboratories Disease Pharmaceuticals 52

KIF1A

JULY 1, 2023

Taking a drug that shelved during development or didn’t receive FDA approval, and assessing its application for another disease, is called drug repositioning. It requires a deep look at former products that ended at various stages of research and development.

Small Molecule 98

Small Molecule FDA Approval Disease Pharmaceutical Companies 98

DrugBank

FEBRUARY 1, 2024

There’s a lot to dig into so we’ve highlighted a few improvements we think are really going to change the game: 300% Increase in Drug-Drug Interaction Data Navigating the complex world of pharmaceuticals can be daunting. DrugBank 6.0 simplifies this with a significant expansion in our drug-drug interaction data.

Research 52

Research Clinical Trials FDA Approval Trials 52