Drugs.com

JUNE 20, 2025

FRIDAY, June 20, 2025 -- The U.S. 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). According to the Mayo.

FDA Approval

Drugs.com

JUNE 30, 2025

MONDAY, June 30, 2025 -- The U.S. 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. Benlysta.

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

Drugs.com

MAY 27, 2025

TUESDAY, May 27, 2025 -- The U.S. Food and Drug Administration has approved Zoryve (roflumilast) topical foam 0.3 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

MONDAY, May 5, 2025 -- The U.S. 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.

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

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

AUGUST 1, 2025

Genomics points to potential targeted treatment options for pediatric gliomas By Tom Ulrich August 1, 2025 Breadcrumb Home Genomics points to potential targeted treatment options for pediatric gliomas Findings suggest that previously-approved precision medicines may& benefit children with certain childhood brain tumors.

Treatment

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

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. CD-21-1615.

FDA

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]

Clinical Trials

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] gmol 1 References ^ “Register of Innovative Drugs” Health Canada. 3 November 2006.

FDA Approval

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. That is a decent hypothesis to explore and their early clinical data at ASCO 2025 looked interesting.

Therapies

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

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] ESI-MS m/z calc.475.0922,

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.

FDA

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]. 2025, 68, 2147−2182 Vamorolone (Agamree). Vamorolone: first approval.

FDA

New Drug Approvals

JUNE 29, 2025

Taletrectinib CAS 1505514-27-1 as salt: 1505515-69-4 , Taletrectinib adipate FDA 6/11/2025, Ibtrozi, To treat locally advanced or metastatic ROS1-positive non-small cell lung cancer AB-106, DS-6051a 405.5 1] Taletrectinib was approved for medical use in the United States in June 2025. [3] Food and Drug Administration.

International

Broad Institute

JULY 31, 2025

By Corie Lok July 31, 2025 Credit: National Cancer Institute \ Winship Cancer Institute of Emory University Lung cancer cells, tagged with fluorescent proteins (green and blue), seen under a microscope. Online July 31, 2025. & Paper cited: Satpathy S et al. Cancer Cell. DOI: 10.1016/j.ccell.2025.07.011

DNA

Broad Institute

JUNE 24, 2025

By Broad Communications June 24, 2025 Credit: Casey Atkins David Liu is a core member at the Broad Institute where he is the Richard Merkin Professor and director of the Merkin Institute for Transformative Technologies in Healthcare. To achieve that goal, we need a new framework for developing and approving drugs.

Treatment

New Drug Approvals

JULY 10, 2025

g/mol O5ZD2TU2B7 FDA 7/3/2025, Ekterly, To treat acute attacks of hereditary angioedema N -[(3-fluoro-4-methoxypyridin-2-yl)methyl]-3-(methoxymethyl)-1-[[4-[(2-oxopyridin-1-yl)methyl]phenyl]methyl]pyrazole-4-carboxamide Sebetralstat , sold under the brand name Ekterly , is a medication used for the treatment of hereditary angioedema. [1]

FDA

The Pharma Data

JULY 2, 2025

FDA Grants Accelerated Approval to Regeneron’s Lynozyfic™ (linvoseltamab-gcpt) for Relapsed or Refractory Multiple Myeloma Regeneron Pharmaceuticals has secured a critical milestone in oncology drug development with the U.S. alone, more than 36,000 new diagnoses and approximately 12,000 deaths are anticipated in 2025.

FDA

Drug Target Review

AUGUST 8, 2025

While monoclonal antibodies and antibody-drug conjugates continue to drive therapeutic pipelines, bispecific T-cell engagers (TCEs) are gaining momentum as a versatile and scalable class of immunotherapies. How many FDA-approved T-cell engagers (TCEs) are there? Global News Wire; 2025 Mar 17. References PatSnap Synapse.

Engineering

New Drug Approvals

AUGUST 7, 2025

5] Repotrectinib was approved for medical use in the United States in November 2023, [5] [6] and in the European Union in January 2025. [3] was granted FDA approval on November 15, 2023. These mutations restrict the ability of drugs to bind to their targets, ultimately resulting in the advancement of tumors.

FDA

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. Treasure Island (FL): StatPearls Publishing; 2025 Jan-.Available The therapeutic landscape for SCD has evolved significantly in recent years.

Disease

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] 16 April 2025. 29 March 2023.

FDA Approval

Codon

JULY 28, 2025

Casgevy , the first FDA-approved CRISPR-based therapy, is also an ex vivo gene therapy; it aims to cure sickle cell disease by editing a patient’s blood-producing stem cells so they generate functional fetal hemoglobin, then returning these corrected cells to the bloodstream.

Immune Response

The Pharma Data

JUNE 15, 2025

The new results were presented in a late-breaking oral presentation (Abstract #LB4001) at the 2025 European Hematology Association (EHA) Congress. were penta-drug refractory, having been exposed to additional lines of treatment. Among these: 84.4% had previously received a bispecific antibody.

Therapies

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] Retrieved 25 January 2025.

FDA

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

The Pharma Data

JULY 2, 2025

FDA Grants Priority Review to Merck’s WINREVAIR™ Based on Landmark ZENITH Trial Showing Dramatic Reduction in Morbidity and Mortality in PAH Patients Merck (NYSE: MRK), operating as MSD outside the U.S. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025.

Trials

The Pharma Data

JUNE 13, 2025

FDA Approves KEYTRUDA® (Pembrolizumab) for Perioperative Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma Merck known as MSD outside the United States and Canada, recently announced that the U.S. 0.89; p = 0.00140).

FDA Approval

New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Jump up to: a b “Novel Drug Approvals for 2024” U.S. January 2025.

FDA

BioPharma Drive: Drug Pricing

JULY 10, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., Kennedy Jr.

Vaccine

Drugs.com

MAY 21, 2025

WEDNESDAY, May 21, 2025 -- The U.S. Food and Drug Administration has approved the humanized monoclonal antibody, Zynyz, (retifanlimab-dlwr) as the first first-line treatment for advanced anal cancer.Zynyz is a programmed death receptor-1 inhibitor.

FDA Approval

BioPharma Drive: Drug Pricing

JULY 30, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from News roundup Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval The Hong Kong-based CSPC will receive $120 million from Madrigal under the deal.

Drugs