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WEDNESDAY, June 11, 2025 -- The U.S. 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.
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.
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.
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.
5, 2025 -- The U.S. Food and Drug Administration has approved Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular edema.Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with diabetic. WEDNESDAY, Feb.
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.
FRIDAY, April 25, 2025 Novavaxs COVID-19 vaccine could soon receive full approval from the U.S. Food and Drug Administration (FDA), the company said Wednesday.The update sent Novavaxs stock up more than 21% in early trading. It also helped ease.
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.
31, 2025 -- The U.S. 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. FRIDAY, Jan. The new pill, developed by Vertex.
18, 2025 -- The U.S. Food and Drug Administration has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for active immunization against invasive meningococcal disease (IMD), according to a press release from. TUESDAY, Feb.
22, 2025 -- The U.S. Food and Drug Administration has approved Spravato (esketamine) CIII nasal spray for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants. WEDNESDAY, Jan.
6, 2025 -- The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in patients with. THURSDAY, Feb.
THURSDAY, March 6, 2025 -- The U.S. Food and Drug Administration has approved TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.TNKase is delivered as a single five-second.
TUESDAY, June 10, 2025 -- The U.S. Food and Drug Administration has approved the Sonu Band, an artificial intelligence-enabled, wearable medical device for at-home treatment of moderate-to-severe nasal congestion in pediatric patients aged 12 and.
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.
TUESDAY, March 25, 2025 -- The U.S. Food and Drug Administration has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women (weighing 40 kg or more) and children (12 years and older.
WEDNESDAY, April 23, 2025 -- The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with chronic spontaneous urticaria.The approval is for patients 12 years and older who remain.
5, 2025 -- The U.S. Food and Drug Administration has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. The approval was based on the results of three phase 3 trials of. WEDNESDAY, Feb.
WEDNESDAY, April 2, 2025 -- The U.S. Food and Drug Administration has approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with.
31, 2025 -- The U.S. 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.
4, 2025 -- The U.S. Food and Drug Administration (FDA) has approved the first-ever clinical trials testing pig kidney transplants in people with kidney failure, marking a major step forward in cross-species transplantation.Two. TUESDAY, Feb.
MONDAY, March 24, 2025 -- The U.S. Food and Drug Administration has approved Tremfya (guselkumab) for adult patients with moderately to severely active Crohn disease.This approval is the fourth indication for this dual-acting interleukin-23.
TUESDAY, April 1, 2025 -- The U.S. Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic test for chlamydia, gonorrhea, and trichomoniasis in women, the agency announced Friday.Women with.
TUESDAY, April 15, 2025 -- The U.S. Food and Drug Administration has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC).The The CheckMate-9DW.
TUESDAY, April 29, 2025 -- The U.S. Food and Drug Administration has approved Zevaskyn (prademagene zamikeracel) for patients with the rare, genetic skin disorder recessive dystrophic epidermolysis bullosa.Zevaskyn is the first and only autologous.
16, 2025 -- The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn disease in adults, according to a press release from Eli Lilly and Company.Omvoh targets. THURSDAY, Jan.
WEDNESDAY, April 16, 2025 -- The U.S. Food and Drug Administration has approved a self-injection version of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who.
18, 2025 -- The U.S. Food and Drug Administration has approved Penmenvy (Meningococcal Groups A, B, C, W, and Y Vaccine) for active immunization against invasive meningococcal disease (IMD), according to a press release from. TUESDAY, Feb.
MONDAY, March 31, 2025 -- The U.S. Food and Drug Administration has approved cabozantinib (Cabometyx), an oral tyrosine kinase inhibitor, for patients with previously treated advanced neuroendocrine tumors, offering a new standard of care for this.
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]
17, 2025 -- Following an extensive scientific review, the U.S. Food and Drug Administration has authorized the marketing of 20 ZYN nicotine pouch products. FRIDAY, Jan. Nicotine pouches -- small synthetic fiber pouches containing nicotine -- are.
19, 2025 -- The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus. WEDNESDAY, Feb. Merilog is a rapid-acting human.
19, 2025 -- The U.S. Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.Merilog is a rapid-acting human. WEDNESDAY, Feb.
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.
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).
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.
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).
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.
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,
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. That is a decent hypothesis to explore and their early clinical data at ASCO 2025 looked interesting.
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.
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.
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