Adding WINREVAIR to background PAH therapy improved exercise capacity and WHO functional class (FC), and reduced the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death
ZENITH data add to growing body of evidence supporting a positive benefit risk profile of WINREVAIR in a broad range of adult patients with PAH RAHWAY, N.J. / Oct 27, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and... Read more
First and only therapy FDA approved in both R/R acute myeloid leukemia (AML) with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation
Second approved indication for Revuforj in less than one year further solidifies Syndax’s leadership in menin inhibition
Included in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for R/R NPM1 mutated AML
Syndax to host conference call today at 2:30 p.m. ET NEW YORK, Oct. 24, 2025 (GLOBE NEWSWIRE)... Read more
This approval is supported by data from the Phase III OASIS clinical trial program evaluating Lynkuet for the treatment of moderate to severe hot flashes due to menopause1
In OASIS 1 and OASIS 2, Lynkuet met the co-primary endpoints of reduction in number and severity of moderate to severe hot flashes day and night at weeks 4 and 12 from baseline1
Hot flashes are a common symptom of menopause2 and one of the main reasons women seek treatment;3 hot flashes may impact women... Read more
Significant unmet need for patients requires new and novel treatments1
DREAMM-7 showed a 51% reduction in the risk of death and tripled median progression-free survival in 3L+ indicated population versus a daratumumab-based triplet2
Blenrep is the only anti-BCMA accessible in the community setting where 70% of patients receive care, and with a new streamlined REMS program3
Robust clinical development is ongoing to advance Blenrep in earlier lines of treatment, including... Read more
FDA approval based on superiority of Gazyva over standard therapy alone, as shown in Phase II NOBILITY and Phase III REGENCY data
Gazyva is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomized Phase III study
Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of color and childbearing age, with up to one third of patients progressing to end-stage kidney... Read more
Updated indication allows the use of RINVOQ® (upadacitinib) prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) that updates the indication... Read more
FDA approves UZEDY® (risperidone) extended-release injectable suspension for subcutaneous use as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.1
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults.1
This approval marks a significant step towards addressing the unmet needs of... Read more
Second-generation delivery device offers cost-effective alternative to hospital care benefiting patients, providers, and payors
Lasix ONYU is the 17th Captisol-enabled™ approved product JUPITER, Fla., Oct. 09, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner SQ Innovation Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Lasix® ONYU (furosemide injection), a novel drug-device... Read more
Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared to placebo (hazard ratio: 0.32; 95% confidence interval: 0.20-0.51; p<0.0001), the primary endpoint of the trial
Libtayo is the current standard of care in advanced CSCC; approval has the potential to change the treatment paradigm for patients in an earlier setting TARRYTOWN, N.Y., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron... Read more
ZORYVE cream 0.05% provides rapid and effective relief of mild to moderate atopic dermatitis in children ages 2 to 5 and is safe and well tolerated
Once-daily, steroid-free cream can be used anywhere on the body for any duration
About 1.8 million children ages 2 to 5 with atopic dermatitis are topically treated in the U.S.
Sixth FDA approval for ZORYVE in just over three years
Commercial product expected to be available by the end of October 2025 WESTLAKE VILLAGE,... Read more
Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal Phase 3 IMforte trial
Zepzelca and atezolizumab combination added to National Comprehensive Cancer Network® Guidelines for SCLC
For U.S. media and investors only DUBLIN, Oct. 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zepzelca® (lurbinectedin) in combination... Read more
Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal Phase III IMforte study
First and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLC
Regimen recommended in National Comprehensive Cancer Network® Guidelines for SCLC* SOUTH SAN FRANCISCO, Calif. / Oct 02, 2025 / Business Wire / Genentech, a member of the Roche Group... Read more
Rhapsido helps to inhibit release of histamine and proinflammatory mediators by targeting BTK, offering unique approach to CSU treatment1
Well-controlled disease observed as fast as two weeks, with demonstrated safety profile that requires no lab monitoring1
1.7 million people in US live with CSU; more than half remain symptomatic despite increasing doses of antihistamines2,3
Remibrutinib also in clinical development for chronic inducible urticaria, food allergy,... Read more
With new label, Dectomax®-CA1 Injectable is the first and only parasite control product with conditional approval to help control economically devastating pest Cochliomyia hominivorax (New World screwworm) PARSIPPANY, N.J. / Sep 30, 2025 / Business Wire / Zoetis Inc. today announced that Dectomax®-CA1 Injectable is the first and only parasite control product to receive conditional approval from the U.S. Food and Drug Administration for the prevention and treatment... Read more
This marks the second FDA-approved indication for Guardant360 CDx as a companion diagnostic in breast cancer treatment
ESR1 mutations are present in 40% of HR+, HER2- advanced breast cancers PALO ALTO, Calif. / Sep 29, 2025 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Guardant360® CDx as a companion diagnostic to identify advanced breast... Read more
TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children six years and older, weighing at least 40 kg
Approval was based on PROTOSTAR study, which showed pediatric patients receiving TREMFYA® achieved high levels of skin clearance vs. placebo at Week 16 HORSHAM, Pa., Sept. 29, 2025 /PRNewswire/ -- Johnson &... Read more
FDA approval extends the indication of Evkeeza to treat younger patients with homozygous hypercholesterolemia (HoFH)
HoFH is an inherited condition characterized by extremely high levels of low-density lipoprotein cholesterol (LDL-C)
Initial Evkeeza approval based on placebo-controlled trial showing Evkeeza, when added to standard lipid-lowering therapies, could lower LDL-C by about 50% compared to placebo in this high unmet need population TARRYTOWN, N.Y., Sept.... Read more
Novel nonpeptide SST2 agonist PALSONIFY advances the treatment paradigm as the first once-daily, oral therapy approved by the FDA to treat acromegaly
Approval based on data from two pivotal Phase 3 trials where PALSONIFY was well tolerated and resulted in rapid, durable, and consistent biochemical control and reduced symptom burden
Launch of lead product PALSONIFY marks a pivotal milestone for Crinetics as the premier endocrine-focused global pharmaceutical company
Investor... Read more
An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor
In the Phase 3 EMBER-3 trial, Inluriyo monotherapy reduced the risk of progression or death by 38% versus endocrine therapy among patients with ESR1-mutated MBC INDIANAPOLIS, Sept. 25, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved... Read more
FDA now concludes "the totality of evidence supports removal of the risk of fatal vaccine-induced disease from modified live virus vaccines from the labeling"i
Further evaluation of supplemental scientific data drove this FDA update; data now peer-reviewed and published
Real-world success and experiences from dermatologists and general practice veterinarians around the U.S. and the world further demonstrate Zenrelia's efficacy INDIANAPOLIS, Sept. 23, 2025 /PRNewswire/... Read more
TREMFYA® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn's disease
TREMFYA® achieved significant rates of clinical remission and endoscopic improvement versus placebo at Week 12 with a subcutaneous induction regimen, consistent with IV induction
Johnson & Johnson is initiating a head-to-head study seeking to demonstrate the superiority of TREMFYA® vs. Skyrizi® (risankizumab)... Read more
The Implantable Tibial Neuromodulation (ITNM) device will expand treatment options for the 16 million people living with urinary urges and involuntary leaks GALWAY, Ireland, Sept. 19, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the Altaviva™ device. The minimally invasive implantable tibial neuromodulation (ITNM) therapy is... Read more
KEYTRUDA QLEX is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute RAHWAY, N.J. / Sep 19, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults... Read more
Opzelura is the first topical JAK inhibitor approved in the U.S. for pediatric atopic dermatitis (AD)
Phase 3 data supporting the approval show that treatment with Opzelura resulted in significant efficacy, with no new safety concerns identified
This milestone marks the third U.S. approval for Opzelura, which is now indicated to treat mild to moderate AD in non-immunocompromised patients 2+ years of age and nonsegmental vitiligo in patients 12+ years of age WILMINGTON,... Read more
Revised label allows treatment of DEB patients from birth
VYJUVEK can now be applied by patients and caregivers PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK® (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic epidermolysis bullosa (DEB) patients... Read more
Expands Amneal’s Affordable Medicines portfolio and broadens patient access BRIDGEWATER, N.J, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem®. Amneal had previously been distributing an authorized generic... Read more
Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand Disease (VWD) and On-Demand and Perioperative Management of Bleeding in Pediatric Patients with VWD1
VONVENDI is the Only Recombinant Von Willebrand Factor Replacement Therapy with Approved Indications in Adults and Children with VWD1
VWD, the Most Common Bleeding Disorder, Impacts More Than 3 Million People in the U.... Read more
Another addition to Amneal’s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references... Read more
SHANGHAI & JERSEY CITY, N.J. / Sep 02, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2
“The FDA approvals of BILDYOS and BILPREVDA mark... Read more
LEQEMBI IQLIK is the first and only anti-amyloid treatment to offer an at-home injection to help patients and care partners continue to treat this progressive, relentless disease after initial treatment of 18 months
LEQEMBI IQLIK will be launched on October 6, 2025, in the U.S. TOKYO and CAMBRIDGE, Mass., Aug. 29, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Headquarters: Cambridge,... Read more
