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

Chemical Biology and Drug Design

FEBRUARY 6, 2025

Analysis of prevalence of ring, nonring, sp 3 -, and sp 2 -hybridized oxygen in approved drugs. For the first time, analysis of distribution of different types of oxygen from center of mass of a molecule.

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

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

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

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 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

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

We note that the only Phase 3 study funded in the FY2024 announcement is the first-ever late-stage clinical trial for the indication of microcystic lymphatic malformations , a serious, rare genetic skin disease with no FDA-approved therapies. Relative to other areas of medicine (e.g.,

Clinical Development

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

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).

FDA Approval

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

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.

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

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

New Drug Approvals

MAY 17, 2025

Jump up to: a b c d e f g h i j k l “FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene” (Press release). Food and Drug Administration (FDA). “Biogen’s ALS Drug Gets Partial Backing From FDA Panel” Bloomberg News. 25 April 2023. 25 April 2023.

FDA Approval

Broad Institute

MAY 21, 2025

In 2012, the University of Pennsylvania team and Novartis launched a collaboration to further develop the technology, which led to the FDA approval for the first commercial CAR T-cell therapy in 2017. In some cases, patients treated with the new therapy remained cancer-free for years.

Therapies

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] Sunvozertinib CAS 2370013-12-8 DZD9008, 584.1

FDA

The Pharma Data

JUNE 25, 2025

The announcement is particularly relevant given the lack of FDA-approved treatment options for AMR, a complication that poses a critical threat to transplant success and long-term graft survival. This form of rejection can occur early or late after transplantation and is notoriously difficult to treat.

FDA

Broad Institute

JUNE 24, 2025

s specific mutation, creating a mouse model of the disease, determining the optimal base editor, performing extensive safety analyses, working with Danaher to manufacture the therapeutic, conducting toxicity studies, and securing FDA approval for the trial. This unprecedented feat required diagnosing K.J.’s

Treatment

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

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. cd-21-0072.

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

The Pharma Data

JULY 2, 2025

Continued approval will hinge on confirmatory data from a Phase 3 study that validates long-term clinical benefits. A New Class of Bispecific Antibody Therapy Lynozyfic is the first FDA-approved bispecific antibody that targets B-cell maturation antigen (BCMA) and CD3, enabling T-cell mediated killing of multiple myeloma cells.

FDA

The Pharma Data

JUNE 15, 2025

Food and Drug Administration (FDA)-approved gene therapy for the treatment of Duchenne muscular dystrophy (DMD). ELEVIDYS is currently the only U.S.

Immune Response

The Pharma Data

JUNE 11, 2025

The company was instrumental in the development of SPINRAZA® (nusinersen), the first FDA-approved treatment for spinal muscular atrophy (SMA), and QALSODY™ (tofersen), an investigational treatment for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).

Trials

New Drug Approvals

JULY 25, 2025

Syn EuropeanJournalofMedicinalChemistry265(2024)116124 Vamorolone (Agamree) On October 26, 2023, Vamorolone, developed jointly by Santhera Pharmaceuticals and ReveraGen BioPharma, has received FDA approval to treat DMD in patients aged 2 years and older [1]. 2] [3] Brand names Vamorolone is the international nonproprietary name. [23]

FDA

New Drug Approvals

JUNE 11, 2025

However, in 2012 it once again failed to convince the FDA of its qualities for treating anxiety and depression. [5] 5] In December 2015, the FDA once again gave gepirone a negative review for depression due to concerns of efficacy. [12] 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review. [13]

FDA

The Pharma Data

JULY 2, 2025

Despite its impact, there are currently no FDA-approved therapies for PMN , and treatment options are limited to non-specific and often toxic agents such as chemotherapy or general immunosuppressants.

Trials

Codon

NOVEMBER 3, 2024

Food and Drug Administration (FDA)-approved drug library, some of which inhibit E. Their algorithm works by discerning which chemical structures are likely to inhibit E. coli bacteria from growing. To train their model, they used a selection of over 2,000 compounds from a U.S.

Vaccine

The Pharma Data

JUNE 15, 2025

The study, which is the largest to date that focuses exclusively on this patient population, shows high overall response rates (ORR) alongside deep and durable responses, offering much-needed hope for individuals whose disease typically carries a poor prognosis.

Therapies

New Drug Approvals

MAY 8, 2025

Food and Drug Administration (FDA). FDA Approves Jaypirca (pirtobrutinib), the First and Only Non-Covalent (Reversible) BTK Inhibitor, for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTK Inhibitor” (Press release). 1 December 2023. August 2023).

FDA Approval

Codon

JUNE 5, 2025

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. Therapeutics There are no FDA-approved therapies built upon Cas12, but the enzyme is currently being used in multiple clinical trials.

DNA

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 Nov 1;6(11):e2344546.

Disease