KHINDIVI is the first and only FDA-approved hydrocortisone oral solution
Commercial launch expected the week of June 2nd
Eton expects combined peak sales of KHINDIVI and ALKINDI SPRINKLE® (hydrocortisone) oral granules to exceed $50 million DEER PARK, Ill., May 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare... Read more
In pivotal Phase 3 trials, TRYPTYR demonstrated rapid natural tear production as early as Day 11-2
TRYPTYR is a first-in-class TRPM8 receptor agonist that rapidly stimulates natural tear production in patients with Dry Eye Disease (DED)3
Approximately 38 million individuals in the U.S. are living with DED, yet less than 10% of diagnosed patients are being treated with a prescription product4 GENEVA / May 28, 2025 / Business Wire / Alcon (SIX/NYSE: ALC), the global... Read more
The Tendyne system replaces mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves, known as severe mitral annular calcification (MAC)
Tendyne offers a new treatment option for patients who are not candidates for open-heart surgery or mitral repair
This approval expands Abbott's portfolio of minimally invasive structural heart therapies in the U.S. ABBOTT PARK, Ill., May 27, 2025 /PRNewswire/ -- Abbott (NYSE: ABT)... Read more
FDA’s approval of YUTREPIA paves the way for prescribers to add a new treatment option for patients with PAH and PH-ILD
YUTREPIA is designed to enhance deep-lung delivery with an easy-to-use device requiring low inspiratory effort
Demonstrated tolerability and titratability in the pivotal INSPIRE study
Liquidia will host a webcast Tuesday, May 27, 2025 at 8:30 a.m. ET to provide an update on commercial launch preparations MORRISVILLE, N.C., May 23, 2025 (GLOBE... Read more
Nucala is the only approved biologic studied in a wide COPD population with an eosinophilic phenotype characterized by blood eosinophil count (BEC) starting at 150 cells/μL
Approval based on the positive MATINEE and METREX phase III trials
MATINEE data included reduction of exacerbations leading to hospitalization and/or emergency department visits
Nearly 70% of patients in the US who are inadequately controlled on inhaled triple therapy have a BEC ≥150 cells/μL... Read more
Once-daily ZORYVE foam provides powerful clearance and rapid itch relief from head to toe with no limitation on duration of use
More than half of the nearly 9 million people in the United States with plaque psoriasis experience scalp involvement
Healthcare providers and individuals with plaque psoriasis can now choose ZORYVE foam or cream to treat plaque psoriasis anywhere it appears on the body
Fifth FDA approval for ZORYVE in less than three years
Management will... Read more
Susvimo can help people with diabetic retinopathy (DR) maintain their vision and prevent progression to blindness with only one treatment every nine months
Susvimo’s innovative technology via the Port Delivery Platform may offer an alternative to regular eye injections in the US
Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating wet, or neovascular, age-related macular... Read more
Stryker's first basivertebral nerve ablation system targets the basivertebral nerve to provide relief from chronic* vertebrogenic low back pain. PORTAGE, Mich., May 19, 2025 /PRNewswire/ -- Stryker (NYSE:SYK), a global leader in medical technologies, announced that its OptaBlate basivertebral nerve ablation system (OptaBlate BVN) received 510(k) clearance from the U.S. Food and Drug Administration. OptaBlate BVNA is used in a targeted minimally invasive procedure providing... Read more
Zynyz® (retifanlimab-dlwr), a PD-1 inhibitor, is now approved for the treatment of advanced squamous cell carcinoma of the anal canal (SCAC) in combination with chemotherapy and as a monotherapy
Patients with SCAC treated with Zynyz achieved a statistically significant improvement in progression-free survival and improvement in overall survival WILMINGTON, Del. / May 15, 2025 / Business Wire / Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration... Read more
Brekiya® becomes the first and only DHE autoinjector that allows patients to self-administer the same medication used in hospitals in a ready-to-use form Product will be available for appropriate patients in the second half of 2025 BRIDGEWATER, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine... Read more
NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for Ryoncil® (remestemcel-L) for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older.
This period of statutory exclusivity... Read more
EMRELIS is the first and only treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression who often face poor prognosis and have limited treatment options
Lung cancer remains the leading cause of cancer-related deaths throughout the world1 NORTH CHICAGO, Ill., May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that EMRELIS™ (telisotuzumab vedotin-tllv) has been granted accelerated approval by the U.S.... Read more
WELIREG becomes the only approved and available treatment in the U.S. for eligible patients with advanced PPGL RAHWAY, N.J. / May 14, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally... Read more
AVMAPKI plus FAKZYNJA to be commercially available by prescription as a convenient oral combination co-packaged together and will be known as “AVMAPKI FAKZYNJA CO-PACK”
Accelerated approval, well ahead of the June 30, 2025 PDUFA action date, was based on the Phase 2 RAMP 201 study that demonstrated a 44% overall response rate in patients with KRAS mutant recurrent LGSOC
Verastem to host investor conference call and webcast today at 2:30 pm ET BOSTON / May 08, 2025... Read more
The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025
SELARSDI is approved for all indications matching the reference product
SELARSDI is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years and older, and the treatment of adult... Read more
Transforming Care for Severe AS Patients IRVINE, Calif. / May 01, 2025 / Business Wire / Edwards Lifesciences (NYSE: EW) announced today that the U.S. Food and Drug Administration (FDA) has approved its transcatheter aortic valve replacement (TAVR) therapy, the SAPIEN 3 platform, for severe aortic stenosis (AS) patients without symptoms, marking the first FDA approval for TAVR in asymptomatic patients.
Approval of the SAPIEN 3 platform (SAPIEN 3, SAPIEN 3 Ultra and... Read more
First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older
IMAAVY delivered rapid and substantial reduction in immunoglobulin G (IgG) levels, one of the root causes of gMG, in both the adult and pediatric pivotal studies
gMG patients taking IMAAVY demonstrated 20 months of lasting disease control and symptom relief in the pivotal... Read more
RINVOQ (upadacitinib) is now the first and only oral Janus Kinase (JAK) inhibitor approved for the treatment of GCA in adults
Also known as temporal arteritis, GCA is the most common vasculitis affecting adults in Western countries2
This marks the ninth approved indication for RINVOQ in the U.S., across rheumatology, gastroenterology, and dermatology1 NORTH CHICAGO, Ill., April 29, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug A... Read more
ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure
Approval based on the pivotal Phase 3 VIITAL™ study, showing ZEVASKYN resulted in significant wound healing and pain reduction after a single treatment with a favorable safety profile
ZEVASKYN to be available through Qualified Treatment Centers beginning in 3Q 2025
Abeona Assist™ patient services program offers personalized support... Read more
Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle
Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success GALWAY, Ireland and SAN DIEGO, April 25, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare... Read more
Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo
In the U.S., there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatment
CSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:... Read more
LIVMARLI Tablet formulation approved for patients with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) FOSTER CITY, Calif. / Apr 14, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of LIVMARLI® (maralixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and Progressive Familial... Read more
Based on the Phase 3 CheckMate-9DW trial, Opdivo plus Yervoy demonstrated a statistically significant overall survival benefit compared to investigator’s choice of lenvatinib or sorafenib1
In the trial, 38% of patients were still alive at 3 years with this dual immunotherapy vs. 24% with the comparator arm1 PRINCETON, N.J. / Apr 11, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®... Read more
VYVGART, the first-in-class FcRn blocker, now offers three administration options, including self-injection with a prefilled syringe
Self-injection provides gMG and CIDP patients with flexibility for when and where to receive treatment – at home, while ‘on the go’ or in a healthcare setting
Approval reflects commitment to innovating the patient experience with individualized, safe and effective therapies Amsterdam, the Netherlands – argenx SE (Euronext &... Read more
Based on the Phase 3 CheckMate-8HW trial, Opdivo plus Yervoy demonstrated reduction in the risk of disease progression or death by 79% vs. chemotherapy in the first-line setting and by 38% vs. Opdivo monotherapy across all lines of therapy 1
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date PRINCETON, N.J. / Apr 08, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug A... Read more
Breakthrough CD19+ B-Cell Targeted Therapy Delivered an 87% Reduction in the Risk of Flares Versus Placebo
UPLIZNA Shown to Deliver Corticosteroid-Free, Flare-Free, Complete Remission for Patients in the MITIGATE Trial
Advances Amgen's Leadership in CD19 Directed, B-Cell Depletion Therapies for Serious Autoimmune Diseases Including NMOSD, IgG4-RD and gMG THOUSAND OAKS, Calif., April 3, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that the U.S.... Read more
Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy with no requirement for a REMS (Risk Evaluation Mitigation Strategy) program1
Phase III data showed Vanrafia achieved proteinuria reduction of 36.1% (P<0.0001) vs. placebo with improvements seen at Week 6 and sustained through Week 36 and favorable safety1,2
IgAN is a progressive, rare kidney disease; up to 50% of patients with persistent proteinuria progress to kidney... Read more
FDA approves leading solution for latent tuberculosis diagnostics, advancing global effort to fight infectious diseases WALTHAM, Mass. / Apr 02, 2025 / Business Wire / Revvity, Inc. (NYSE: RVTY), today announced that the U.S. Food and Drug Administration (FDA) has approved the Auto-Pure 2400 liquid handling platform with the T-SPOT™.TB test. Initially launched outside the U.S. in 2024, this powerful combination allows laboratories to improve productivity while maintaining... Read more
Based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death vs. neoadjuvant chemotherapy alone WILMINGTON, Del. / Mar 31, 2025 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the US for the treatment... Read more
Qfitlia Becomes the Sixth Alnylam-Discovered RNAi Therapeutic Approved by U.S. FDA and First and Only to Treat Hemophilia A or B With or Without Inhibitors CAMBRIDGE, Mass. / Mar 28, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today highlighted the significance of the U.S. Food and Drug Administration’s (FDA) approval of Qfitlia™ (fitusiran), the sixth Alnylam-discovered RNAi therapeutic approved in... Read more
