Pfizer wins FDA approval for its $7B colitis drug
BioPharma Drive: Drug Pricing
OCTOBER 13, 2023
Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.
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BioPharma Drive: Drug Pricing
OCTOBER 13, 2023
Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.
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.
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Chemical Biology and Drug Design
JUNE 19, 2025
ABSTRACT Fused pyrimidine scaffolds serve as a flexible and versatile foundational heterocycle in the field of pharmaceutical development. The presence of thienopyrimidine derivatives in several FDA-approved drugs and clinical trial candidates underscores their therapeutic potential and safety profile.
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
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.
New Drug Approvals
APRIL 11, 2025
2] Fitusiran was approved for medical use in the United States in March 2025. [2] 1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] 26 March 2025.
Drug Patent Watch
APRIL 8, 2025
Patient Safety in the Era of Generic Drugs: A Call to Action As the pharmaceutical industry continues to evolve, one thing remains constant: the need for patient safety. With the rise of generic drugs, it's more important than ever to ensure that these alternatives meet the same high standards as their brand-name counterparts.
The Pharma Data
JULY 2, 2025
Meeting the Growing Demand for High-Concentration Biologics High-concentration biologics—generally defined as injectable formulations with protein concentrations exceeding 100 mg/mL—have become a strategic priority for many pharmaceutical developers. WuXiHigh™ 2.0: Pushing the Boundaries With WuXiHigh™ 2.0, Source link
Drug Patent Watch
APRIL 29, 2025
"Market Access: The Hidden Hurdle in Generic Drug Commercialization As a seasoned pharmaceutical professional, I've seen it time and time again: a generic drug finally receives FDA approval, only to stall in the market due to a seemingly insurmountable obstacle - market access.
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.
New Drug Approvals
JULY 9, 2025
2] [4] Sunvozertinib was approved for medical use in the United States in July 2025. [1] 1] History Sunvozertinib is being developed by Dizal Pharmaceutical. [5] 5] In China, it was conditionally approved in 2023 for the treatment of NSCLC and full approval is contingent on results of phase 3 clinical trials. [6]
New Drug Approvals
JUNE 11, 2025
2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review.
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.
The Pharma Data
JUNE 9, 2025
Xywav: A Low-Sodium Alternative with FDA Approval Xywav is a uniquely formulated, low-sodium oxybate therapy, and remains the only product of its kind approved by the U.S. It is also approved for adult patients with idiopathic hypersomnia (IH).
New Drug Approvals
MAY 15, 2025
5] Leniolisib was approved for medical use in the United States in March 2023. [5] 5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] 5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] New Drug Therapy Approvals 2023 (PDF).
The Pharma Data
DECEMBER 16, 2020
17, 2020 /PRNewswire/ — CNS Pharmaceuticals, Inc. Recent correspondence between the Company and the FDA resulted in modifications to the previously disclosed trial design, including designating overall survival (OS) as the primary endpoint of the study. About CNS Pharmaceuticals, Inc.
Drug Patent Watch
JANUARY 7, 2025
Generic drugs play a crucial role in providing affordable medication options to patients. As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options. What Are Generic Drugs?
The Pharma Data
AUGUST 27, 2020
Food and Drug Administration (FDA) has approved FoundationOne®Liquid CDx, Foundation Medicine’s comprehensive pan-tumour liquid biopsy test for patients with solid tumours. The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes.
SugarCone Biotech
JUNE 19, 2025
Finally, while there are clear front runners among the pharmaceutical companies developing targeted therapeutics for these antigens there are also emerging biotechs aggressively pursuing these targets. Now to antibody-drug conjugates (ADC) where we saw some early programs with difficult toxicities. An awesome space to watch.
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. 2) because the FDA employees who approved the application were not “Officers of the United States.” II, § 2, cl.
Drug Target Review
JANUARY 8, 2024
We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. What evidence is there that we can reverse aging with drugs?
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.
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.
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.
The Pharma Data
JUNE 25, 2025
Biogen emphasized that no dose-limiting toxicities were observed, and there were no reports of serious adverse events directly attributable to the study drug. Strategic Collaboration with Ionis Pharmaceuticals Salanersen originated from Biogen’s longstanding collaboration with Ionis Pharmaceuticals, Inc. ,
The Pharma Data
NOVEMBER 27, 2020
FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. Food and Drug Administration (“FDA”) has approved Danyelza (naxitamab-gqgk) 40mg/10ml. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA.
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.
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.
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.
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] Crinecerfont was approved for medical use in the United States in December 2024. [2] 321839-75-2 Molecular Weight 519.50
New Drug Approvals
JULY 8, 2025
1428321-10-1 Pritelivir mesylate is an antiviral drug currently under development, specifically targeting herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). Pritelivir (development codes AIC316 or BAY 57-1293 ) is a direct-acting antiviral drug in development for the treatment of herpes simplex virus infections (HSV).
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] under nitrogen.
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.
The Pharma Data
OCTOBER 21, 2020
a biopharmaceutical company developing multiple assets in the ophthalmic and injectable areas, announced today it received approval from the U.S. Food and Drug Administration (FDA) to market Ephedrine Sulfate Injection in a ready-to-use 50mg/10 ml single use vial presentation. BRIDGEWATER, N.J., and Canada.
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. Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S.
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.
The Pharma Data
JANUARY 6, 2021
The research collaboration is aimed at identifying novel lead compounds and repurposing existing drugs for rheumatoid arthritis and nonalcoholic steatohepatitis, leveraging Standigm’s AI-powered drug discovery platforms : Standigm BEST , Standigm Insight , and Standigm ASK. Standigm is an AI-driven drug discovery company.
The Premier Consulting Blog
JANUARY 14, 2025
The FDAs Oncology Center of Excellence (OCE) plays a pivotal role in fostering innovation, collaboration, and efficiency in the development and evaluation of oncology products. These include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and the Accelerated Approval Pathway (AAP).
The Pharma Data
JULY 29, 2021
Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
FDA Law Blog: Biosimilars
JUNE 27, 2023
Valentine Named Top Lawyer Under 40; Only Food and Drug Lawyer Selected Hyman, Phelps & McNamara, P.C. (HP&M) James was only one of five life sciences attorneys selected and the only food and drug lawyer to make the list. HP&M’s James E. Valentine , as a 2023 Rising Star.
Drug Target Review
JUNE 5, 2025
Currently, three FDA-approved disease-modifying drug therapies are available: hydroxyurea, crizanlizumab and L-glutamine, though each has limitations that affect patient compliance. The use of FDA-approved medications for preventing vaso-occlusive events in sickle cell disease. JAMA Netw Open. 2023.44546.
The Pharma Data
JUNE 11, 2025
Ionis Begins Pivotal Phase 3 REVEAL Study of ION582 in Angelman Syndrome, Dosing First Patient in Global Trial Ionis Pharmaceuticals , Inc. This open-label extension aims to provide further insights into the long-term safety and efficacy of the drug while allowing continued access to therapy for trial participants. Source link
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.
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.
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