Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA's June deadline - 51 dogs enrolled to date; ~49 more expected SAN FRANCISCO, CA / ACCESS Newswire / December 10, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) today announced that the U.S. Food and Drug Administration (FDA) has granted renewal of the conditional approval for Canalevia-CA1... Read more
Expands Amneal’s injectables portfolio with an essential medicine used in hospitals for emergency and perioperative care BRIDGEWATER, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose vials. This medicine is... Read more
In the MZL cohort of TRANSCEND FL, Breyanzi delivered deep and durable responses in 95.5% of patients while demonstrating a consistent safety profile
Breyanzi is now the only CAR T cell therapy approved by the FDA for five cancer types, the most of any CD19-directed CAR T cell therapy PRINCETON, N.J. / Dec 04, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Breyanzi® (... Read more
Approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL in which all patients were previously treated with a covalent BTK inhibitor
This expanded indication represents a substantial increase in the number of CLL/SLL patients who may benefit from Jaypirca and aligns with the patient population endorsed by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) INDIANAPOLIS, Dec. 3, 2025 /PRNewswire/ -- Eli... Read more
Represents second complex respiratory therapeutic product approval in Q4 2025 BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR® HFA (albuterol sulfate inhalation aerosol), a registered... Read more
Approval underscores Amneal’s advanced sterile manufacturing capabilities and expansion within complex ophthalmic therapies; Launch expected in Q1 2026 BRIDGEWATER, N.J., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied... Read more
Based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of progression, recurrence or death and a 22% reduction in the risk of death for the IMFINZI regimen vs. chemotherapy alone WILMINGTON, Del. / Nov 26, 2025 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients... Read more
PADCEV plus Keytruda is the first and only approved perioperative treatment regimen that can significantly improve survival over current standard of care (surgery alone) in cisplatin-ineligible patients with muscle-invasive bladder cancer
Approval is based on unprecedented data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression or death and a 50% reduction in the risk of death compared to surgery alone
Represents... Read more
Represents the first PD-1 inhibitor plus ADC regimens for this patient population RAHWAY, N.J. / Nov 21, 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® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued... Read more
Following Priority Review, the U.S. FDA granted HYRNUO® (sevabertinib) approval for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. WHIPPANY, N.J. / Nov 20, 2025 / Business Wire / Bayer announced today that the U.S. Food and Drug Administration... Read more
First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period
Monthly dosing option in all approved indications provides greater dosing flexibility for more personalized patient care TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD® (aflibercept) Injection 8 mg... Read more
Global Confirmatory Phase 3 DeLLphi-304 Trial Showed IMDELLTRA Reduced Risk of Death by 40% Compared to Chemotherapy
Underscores IMDELLTRA as a Recognized Standard of Care Treatment for Patients With Extensive Stage Small Cell Lung Cancer That Has Progressed THOUSAND OAKS, Calif., Nov. 19, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to IMDELLTRA® (tarlatamab-dlle) for the treatment... Read more
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapyIn the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2 with approximately 3 out of 4 patients achieving a complete r... Read more
REDEMPLO is the first and only FDA-approved medicine to be studied in patients with genetically confirmed and clinically diagnosed FCS
People living with FCS have extremely high triglyceride levels and a substantially higher risk of acute pancreatitis and related long-term complications, often resulting in a reduced quality of life
The FDA approval is based on positive results from the Phase 3 PALISADE study where REDEMPLO significantly reduced triglycerides from baseline... Read more
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is the first and only bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line setting
In the Phase 3 EPCORE® FL-1 trial, fixed duration EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2, with approximately three out of four patients achieving a complete response
This approval marks the third indication... Read more
First-to-market complex injectable with expected launch in Q1 2026 BRIDGEWATER, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque® (iohexol) injection. Amneal expects to launch the product in the first quarter of... Read more
NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients
Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse
FDA grants full approval of KOMZIFTI ahead of PDUFA target action date
Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily administration, and ease of co-administration... Read more
Phase 3 AQUILA study showed DARZALEX FASPRO® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring
Landmark approval supports earlier intervention and disease interception of multiple myeloma for the first time HORSHAM, Pa., Nov. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab... Read more
CAPLYTA®, in combination with an oral antidepressant, demonstrated superior efficacy with a favorable safety and tolerability profile consistent with established indications1,2
In pivotal trials, CAPLYTA® did not increase mean weight gain, metabolic changes, or reported sexual side effects1,2
In a six-month open-label extension safety study, safety profile was consistent with pivotal studies and 80% of MDD patients taking CAPLYTA® achieved response, with... Read more
Company’s first metered-dose inhalation (MDI) product and establishes a new growth vector for the Affordable Medicines segment BRIDGEWATER, N.J., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has tentatively approved the Company’s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol (40 mcg/actuation and... Read more
WARSAW, Ind., Oct. 28, 2025 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced the FDA approval of its 3P™ Pediatric Plating Platform™ Small-Mini System, the second of several systems in the 3P family. This represents the company’s 6th FDA approval in 2025.
The 3P Small-Mini System is a versatile plate and screw solution... Read more
Omvoh now offers patients a simplified maintenance experience with one monthly injection, replacing the previous two-injection regimen
Omvoh single-injection dosing will be available for U.S. patients in early 2026
This is the third FDA approval for Omvoh this year, following approvals for Crohn's disease and a citrate-free formulation INDIANAPOLIS, Oct. 27, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration... Read more
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
