Drugs.com

AUGUST 7, 2025

Food and Drug Administration has approved the SetPoint System, a neuroimmune modulation device for the treatment of adults living with moderate-to-severe rheumatoid arthritis (RA).The THURSDAY, Aug. 7, 2025 -- The U.S. The SetPoint System is indicated.

FDA Approval

Drugs.com

JUNE 20, 2025

Food and Drug Administration has approved Andembry (garadacimab-gxii) as the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE). FRIDAY, June 20, 2025 -- The U.S. According to the Mayo.

FDA Approval

Science Daily: Pharmacology News

JULY 31, 2025

By analyzing gene expression in brain cells, they discovered that some FDA-approved cancer medications could reverse damage caused by Alzheimer's. In an exciting breakthrough, researchers have identified cancer drugs that might reverse the effects of Alzheimer's disease in the brain.

FDA Approval

Chemical Biology and Drug Design

JULY 29, 2025

abscessus, through a virtual screening of FDA approved drugs on salicylate synthase. A drug repurposing strategy was applied against M. Eleven potential ligands were found; among these, three were confirmed as potent inhibitors of the enzyme.

FDA Approval

Chemical Biology and Drug Design

FEBRUARY 6, 2025

This work presents a comprehensive analysis of oxygen atoms in approved drugs, aiming to streamline drug design and discovery efforts. The study examines the frequency, distribution, prevalence, and diversity of oxygen atoms in a dataset of 2049 small molecules approved by the FDA and other agencies.

FDA Approval

Drugs.com

JUNE 30, 2025

Food and Drug Administration has approved an autoinjector of Benlysta (belimumab) for subcutaneous injection in patients ≥5 years of age with active lupus nephritis who are receiving standard therapy. MONDAY, June 30, 2025 -- The U.S. Benlysta.

FDA Approval

Drugs.com

AUGUST 11, 2025

Food and Drug Administration has approved the single-dose Ajovy (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents. MONDAY, Aug. 11, 2025 -- The U.S. In the United States, one in 10 children.

FDA Approval

Covalent Modifiers

JULY 23, 2025

Recent drug discovery efforts culminating from work during the past decade have resulted in two FDA-approved inhibitors, sotorasib and adagrasib, which target the KRASG12C mutant allele. Ongoing medicinal chemistry efforts across academia and industry have continued developing more potent and efficacious KRASG12C inhibitors.

FDA Approval

Drugs.com

MAY 27, 2025

Food and Drug Administration has approved Zoryve (roflumilast) topical foam 0.3 TUESDAY, May 27, 2025 -- The U.S. percent for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.Through.

FDA Approval

Drugs.com

MAY 5, 2025

Food and Drug Administration has approved the SAPIEN 3 platform, a transcatheter aortic valve replacement (TAVR) therapy, for patients with severe aortic stenosis without symptoms. The approval is the first for TAVR. MONDAY, May 5, 2025 -- The U.S.

FDA Approval

The Pharma Data

JUNE 26, 2025

FDA Approves Streamlined Monitoring Requirements and REMS Program Removal for Bristol Myers Squibb’s CAR T Cell Therapies Breyanzi and Abecma, Marking Milestone Toward Expanding Access to Cancer Treatment In a significant regulatory development, Bristol Myers Squibb announced that the U.S.

FDA Approval

Crown Bioscience

JULY 17, 2025

Oncology drug approvals in H1 2025 In the first half of 2025, the FDA’s Center for Drug Evaluation and Research (CDER) approved a total of 16 novel drugs , with half of these drugs related to the treatment of cancer.

FDA Approval

Chemical Biology and Drug Design

JUNE 19, 2025

The presence of thienopyrimidine derivatives in several FDA-approved drugs and clinical trial candidates underscores their therapeutic potential and safety profile. The review elaborates on the primary approach for synthesis of thienopyrimidines, using thiophene derivatives or pyrimidine analogues.

FDA Approval

The Pharma Data

JUNE 11, 2025

FDA Approves Tablet Formulation of BeOne’s BRUKINSA® for All Approved Indications, Offering Greater Convenience for Patients with B-cell Cancers BeOne Medicines Ltd. Food and Drug Administration (FDA). a global oncology-focused biopharmaceutical company, has received a significant regulatory milestone from the U.S.

FDA Approval

The Pharma Data

JUNE 9, 2025

FDA Approves Merck’s ENFLONSIA™ to Protect Infants from Severe RSV Illness Merck operating as MSD outside the United States and Canada, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for ENFLONSIA™ (clesrovimab-cfor).

FDA Approval

The Pharma Data

JUNE 25, 2025

FDA Approves Label Update for Lilly’s Amyvid, Expanding Its Role in Alzheimer’s Disease Diagnosis and Therapy Guidance In a major development for Alzheimer’s diagnostics, Eli Lilly and Company (NYSE: LLY) announced that the U.S. At the time, its use was primarily restricted to supporting the diagnostic process.

FDA

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Clinical Development

The Pharma Data

JUNE 16, 2025

FDA Approves ANDEMBRY (garadacimab-gxii) The First Once-Monthly Prophylactic HAE Therapy Targeting Factor XIIa CSL a leading biotechnology company with a strong track record of developing innovative medicines for patients with rare and serious disorders, today announced that the U.S.

FDA Approval

BioPharma Drive: Drug Pricing

AUGUST 8, 2025

Elsewhere, Jazz won FDA approval of a brain cancer drug and Novo decided to advance a Prothena medicine into Phase 3. Sarepta reported a quarter-on-quarter dip in sales for its Duchenne gene therapy.

FDA Approval

thought leadership

JULY 8, 2025

Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities, especially in competitive therapeutic areas.

FDA

Broad Institute

AUGUST 1, 2025

Food and Drug Administration (FDA)-approved inhibitors that broadly block FGFR. Currently there are no FDA-approved therapies or clinical trials specifically for FGFR-altered pediatric gliomas.

Treatment

New Drug Approvals

MAY 17, 2025

3] Tofersen was approved for medical use in the United States in April 2023, [3] [6] and in the European Union in May 2024. [4] 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] Food and Drug Administration (FDA). Jump up to: a b New Drug Therapy Approvals 2023 (PDF).

FDA Approval

The Pharma Data

JUNE 20, 2025

FDA Approves Dupixent as the First and Only Targeted Therapy for Adults with Bullous Pemphigoid In a groundbreaking development for patients suffering from a rare and debilitating autoimmune skin disease, the U.S. If approved in those regions, the therapy could become a global standard of care for this devastating disease.

FDA Approval

The Pharma Data

JUNE 25, 2025

FDA Orphan Drug Designation for Antibody-Mediated Rejection in Solid Organ Transplantation The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to riliprubart , an investigational immunology therapy developed by Sanofi, for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.

FDA

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). Twenty-four patients were enrolled in this higher-dosage analysis.

FDA Approval

New Drug Approvals

JULY 9, 2025

2] [4] Sunvozertinib was approved for medical use in the United States in July 2025. [1] 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] Food and Drug Administration (FDA). 2 July 2025. Retrieved 7 July 2025.

FDA

The Pharma Data

JULY 2, 2025

Currently, more than 20% of FDA-approved monoclonal antibodies (mAbs) fall into this category, reflecting a growing industry trend. Despite these benefits, the development and commercialization of high-concentration biologics come with formidable challenges. WuXiHigh™ 2.0: Pushing the Boundaries With WuXiHigh™ 2.0,

FDA Approval

The Pharma Data

AUGUST 1, 2025

Food and Drug Administration (FDA). The approval authorizes AUCATZYL® for the treatment of adult patients aged 26 and older diagnosed with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) in all 27 European Union member states. FDA approval in November 2024, and a U.K.

Therapies

New Drug Approvals

JUNE 11, 2025

4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] The FDA rejected approval for gepirone in 2002 and 2004. [5]

FDA

The Pharma Data

JUNE 25, 2025

Ionis originally discovered the compound as part of its antisense technology platform , which has led to multiple FDA-approved therapies across neurological and rare disease indications. Under the terms of the agreement, Biogen holds the exclusive worldwide rights to develop, manufacture, and commercialize salanersen.

Therapies

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. .

FDA

Broad Institute

JULY 21, 2025

The scientists delivered the prime editors to cells in mice using clinically validated viruses called AAVs, which are already used in FDA-approved gene therapies targeting brain cells. Moreover, the function of their Atp1a3 protein was restored in the brain, and their motor and cognitive deficits were ameliorated.

Disease

New Drug Approvals

JULY 25, 2025

Vamorolone was approved by the FDA in October 2023 for the management of DMD in patients ≥2 years of age. In December 2023, it was approved in the EU for the treatment of patients ≥4 years of age. 2] Vamorolone was approved for medical use in the European Union in December 2023. [2] Food and Drug Administration (FDA).

FDA

New Drug Approvals

APRIL 11, 2025

2] Fitusiran was approved for medical use in the United States in March 2025. [2] 2] The fixed dose of fitusiran is not approved because it led to excessive clotting in some participants. [2] 2] The US Food and Drug Administration (FDA) granted the application for fitusiran orphan drug and fast track designations. 26 March 2025.

Clinical Trials

New Drug Approvals

MAY 9, 2025

2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3] 2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Food and Drug Administration (FDA). 1] [4] It is taken by mouth. [1]

FDA

SugarCone Biotech

JUNE 19, 2025

The results were remarkable for this very sick patient population, with a median OS of 14 months at the dose of 10 mg given every 2 weeks: The data supported FDA approval, in May 2024, of tarlatamab for refractory ES-SCLC.

Therapies

Broad Institute

MAY 21, 2025

A similar CAR from another company, Kite Pharmaceuticals (now a Gilead company), was approved by the FDA in 2017 as the second commercial CAR T-cell therapy. After their clinical results, their technology was licensed to Juno Therapeutics (later acquired by Bristol Myers Squibb.)

Therapies