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Food and Drug Administration has approved Widaplik (telmisartan, amlodipine, and indapamide) for the treatment of hypertension in adults.The combination pill is the first and only FDA-approved triple combination. WEDNESDAY, June 11, 2025 -- The U.S.
FRIDAY, June 20, 2025 — A new shot to prevent HIV infection has just been approved — and it only needs to be taken twice a year. Food and Drug Administration (FDA) approved lenacapavir, a long-acting injection. On Wednesday, the U.S.
Food and Drug Administration has approved a prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster). MONDAY, July 21, 2025 -- The U.S. The existing vaccine consists of two.
Food and Drug Administration (FDA) has signed off on the first-ever cream specifically approved for treating chronic hand eczema (CHE). THURSDAY, July 24, 2025 — The U.S. CHE is common condition marked by redness, itching and cracking on the.
The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.
FRIDAY, June 20, 2025 — A new shot to prevent HIV infection has just been approved — and it only needs to be taken twice a year.On Food and Drug Administration (FDA) approved lenacapavir, a long-acting injection that was shown to. Wednesday, the U.S.
A drug repurposing strategy was applied against M. abscessus, through a virtual screening of FDAapproveddrugs on salicylate synthase. There are currently no specific drugs, and the recommended regimens are usually ineffective.
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.
Analysis of prevalence of ring, nonring, sp 3 -, and sp 2 -hybridized oxygen in approveddrugs. This work presents a comprehensive analysis of oxygen atoms in approveddrugs, aiming to streamline drug design and discovery efforts.
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.
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.
The presence of thienopyrimidine derivatives in several FDA-approveddrugs 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.
Oncology drugapprovals 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.
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.
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.
FDAApproves 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.
FDAApproves 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.
FDAApproves 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).
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.
FDAApproves 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.
Currently, more than 20% of FDA-approved monoclonal antibodies (mAbs) fall into this category, reflecting a growing industry trend. Moreover, these factors may affect drug safety and efficacy by increasing the likelihood of immunogenic responses. WuXiHigh™ 2.0: Pushing the Boundaries With WuXiHigh™ 2.0, Source link
Xywav: A Low-Sodium Alternative with FDAApproval 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 Orphan Drug Designation for Antibody-Mediated Rejection in Solid Organ Transplantation The U.S. 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.
FDAApproves 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.
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.
Biogen emphasized that no dose-limiting toxicities were observed, and there were no reports of serious adverse events directly attributable to the study drug. The most common AEs included pyrexia (fever) and upper respiratory tract infections.
In the race to generic drugapproval, timing is everything. Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities, especially in competitive therapeutic areas.
FDAApproves 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.
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] 2] [4] Sunvozertinib was approved for medical use in the United States in July 2025. [1]
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.
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 FDAapproval, in May 2024, of tarlatamab for refractory ES-SCLC. Now to antibody-drug conjugates (ADC) where we saw some early programs with difficult toxicities.
Syn EuropeanJournalofMedicinalChemistry265(2024)116124 Vamorolone (Agamree) On October 26, 2023, Vamorolone, developed jointly by Santhera Pharmaceuticals and ReveraGen BioPharma, has received FDAapproval to treat DMD in patients aged 2 years and older [1]. Vamorolone: first approval. Drugs 2024, 84, 111− 117. (71)
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] Food and Drug Administration.
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 FDAapproval for the trial. This unprecedented feat required diagnosing K.J.’s
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. The study’s primary endpoint focuses on expressive communication, one of the most impaired and distressing symptoms of Angelman syndrome. Source link
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.
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.
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.
7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] 14] Pirtobrutinib was approved for medical use in the European Union in November 2023. [2] Jump up to: a b c “Drug Trials Snapshots: Jaypirca” U.S. 2] PATENTS Guisot, N.
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] Suzetrigine is taken by mouth. [1]
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] Jump up to: a b c d e f g “FDAapproves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer” U.S. 1] [4] It is taken by mouth. [1]
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.
were penta-drug refractory, having been exposed to additional lines of treatment. 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.
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