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
Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz® over treatment area of 240 cm2
Completion of this study marks a key milestone towards a planned summer 2026 FDA submission for FDA approval for the use of Ameluz® on all non-face and scalp areas WOBURN, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing... Read more
MIAMI, FL, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced multiple presentations at The Society on Sarcopenia, Cachexia, and Wasting Disorders (SCWD) 18th International Conference, and the SCWD’s Regulatory and Clinical Trials Update Regulatory Workshop, both in Rome, Italy.
18th International... Read more
Investigational T-cell engager, surovatamig, and CAR T-cell therapy, AZD0120, will show potential with initial data across multiple blood cancers
New results will showcase benefit of CALQUENCE® in patients with mantle cell lymphoma and chronic lymphocytic leukemia
New data will further support clinical benefits of ULTOMIRIS® in paroxysmal nocturnal hemoglobinuria and its potential to improve outcomes for pediatric patients with hematopoietic stem cell transplant-associated... Read more
Newest assay expands TRUFORMA market opportunity by building on endocrinology foundation to address reproductive health in the equine segment ANN ARBOR, MI / ACCESS Newswire / December 4, 2025 / Zomedica Corp. (OTCQB:ZOMDF) ("Zomedica" or the "Company"), an animal health company offering innovative point-of-care diagnostic and therapeutic device products for equine and companion animals, today announced the expansion of its TRUFORMA platform with the launch of its... Read more
Phase 2 clinical trial initiated to evaluate SEMA3A mAb as potential treatment for Alport syndrome Milestone payment to Evotec expected upon first dosing of first study participant in early 2026 HAMBURG, DE / ACCESS Newswire / December 4, 2025 / Evotec SE (Frankfurt Stock Exchange:EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ:EVO) today announced that its partner Bayer AG has initiated a Phase 2 clinical study of a kidney disease... Read more
BAY 3401016 is an investigational monoclonal antibody with potential to block a protein called Semaphorin 3A (Sema3A), which is thought to be involved in the progression of kidney damage in Alport Syndrome (AS), a rare genetic disorder
Bayer explores opportunity to address high unmet medical need of patients suffering from AS and advances research efforts through close cooperation with AS patient organizations
Derived from the strategic research cooperation with Evotec,... Read more
Long-term LEQEMBI treatment suggests potential to delay disease progression from Mild Cognitive Impairment (MCI) to moderate Alzheimer's disease by up to 8.3 years in low-amyloid group who started treatment at an early stage
New safety and efficacy data presented at scientific symposium on subcutaneous formulation for LEQEMBI initiation treatment, which is under regulatory review in the United States TOKYO and CAMBRIDGE, Mass., Dec. 3, 2025 /PRNewswire/ -- Eisai... 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
MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IHL-42X, the Company’s oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea (OSA).
The Fast Track designation was supported by promising... Read more
Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee
BMS Remains Blinded to Study Data PRINCETON, N.J. / Dec 03, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY, “BMS”) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, the company identified... Read more
Bayer revealed first results of the pediatric study from the pivotal clinical development program QUANTI for its low-dose MRI contrast agent
QUANTI Pediatric evaluated the pharmacokinetics and safety of gadoquatrane in children (birth to <18) at a gadolinium dose of 0.04 mmol Gd/kg body weight, representing a dose reduction of 60 percent compared to the macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight
Data are part of submissions to health authorities worldwide... Read more
TOKYO and CAMBRIDGE, Mass., Dec. 2, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name: LEQEMBI®), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in cerebrospinal fluid (CSF) was... Read more
Submission based on positive BaxHTN Phase III trial results which demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension
If approved, baxdrostat could be the first aldosterone synthase inhibitor to receive regulatory authorization WILMINGTON, Del. / Dec 02, 2025 / Business Wire / AstraZeneca’s New Drug Application (NDA) for baxdrostat has been accepted for Priority... Read more
Development plan positions OcuRing™-K for advancement in the fast-growing, multi-billion-dollar global cataract surgery market TEL AVIV, Israel, Dec. 02, 2025 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) today announced, through its pharmaceutical division, the commencement of its development plan for OcuRing™-K, LayerBio’s patented, drop-less, intraoperatively administered sustained-release ocular therapy designed to deliver controlled, site-specific... Read more
sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025
First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA
Primary and key secondary endpoints met with high statistical significance (p <0.0001)
Favorable recurrence outcomes at one-year follow-up
BCC is the most common skin cancer in the US with more than 3 million cases diagnosed annually1 WOBURN, Mass., Dec. 02,... Read more
Data being presented showcases AbbVie's breadth and depth of research across a range of therapeutic modalities such as T-Cell Engagers, BCL-2 Inhibitors and Antibody-Drug Conjugates for a spectrum of difficult-to-treat blood cancers NORTH CHICAGO, Ill., Dec. 2, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it will unveil new data at the 2025 American Society of Hematology (ASH) Congress, showcasing continued advances in research across multiple blood cancers... Read more
Study further expands clinical development program of Bayer’s long-acting reversible intrauterine system Mirena® (levonorgestrel-releasing intrauterine system) 52 mg.
Approximately 121 out of every 100,000 women develop nonatypical endometrial hyperplasia (NAEH), a benign form of endometrial thickening, each year.1 Currently, there are no approved medical treatment options for NAEH in the U.S.
Mirena is globally available in more than 120 countries, and approved in... Read more
BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced that Chirag Patel, Co-Chief Executive and President, and Tasos Konidaris, Chief Financial Officer, will participate in following upcoming investor conferences:
Piper Sandler 2025 Healthcare ConferenceDate: December 3, 2025Fireside Chat: Wednesday, December 3, 2025, at 9:30AM ESTLocation: New York, NY
J.P. Morgan 2026 Healthcare ConferenceDate: January 12-15,... Read more
BANGALORE, India / Dec 02, 2025 / Business Wire / Aurigene Oncology Limited, a clinical-stage biopharmaceutical company developing novel therapies in oncology, today announced initial clinical results from 1st two cohorts of its ongoing Phase 1 clinical trial evaluating AUR112 in patients with relapsed or refractory lymphoid malignancies. Early findings show that AUR112 is safe, well tolerated, demonstrating meaningful clinical activity, with objective responses observed... 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
New data published in Pain Physician shows significant improvement in functional outcomes with iovera°
Fewer iovera° patients required additional spine injections after 180 days
No treatment-related adverse events were reported BRISBANE, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced... 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
Centargo compatible with Ultravist® (iopromide), Isovue® (iopamidol), Optiray® (ioversol), Omnipaque™ (iohexol) and now, Visipaque™ (iodixanol)
Follows recent FDA clearance to expand the use of compatible contrast agent presentations, adding single-dose vials in addition to Imaging Bulk Package presentations
Radiology suites now have the ability to further manage contrast consumption and waste, while providing greater flexibility for those transitioning to bulk... Read more
Phase II ARCHER trial showed a significant reduction in left ventricular (LV) mass (p=0.0117) and improvements in multiple key cardiac MRI (CMR) measures of structural heart recovery in patients with acute myocarditis. Results provide clinical evidence that CardiolRx™ reduces inflammation-driven structural damage in the heart, an important cause of heart failure progression. The ARCHER data strengthen the scientific and clinical rationale for Cardiol's lead... Read more
Transaction boosts Solta Medical's position to meet rising demand in China's growing aesthetics market LAVAL, QC / ACCESS Newswire / December 1, 2025 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC), a global, diversified pharmaceutical company, along with its global aesthetic business, Solta Medical, today announced the successful completion of the acquisition of Wuhan Shibo Zhenmei Technology Co., Ltd., consisting of the Shibo group's aesthetics distribution business.... Read more
Iberdomide shows deep and sustained responses in newly diagnosed multiple myeloma
First-in-class lymphoma CELMoD™ agent, golcadomide, delivers durable responses in combinations across aggressive and indolent lymphomas
First-in-class BCL6 ligand-directed degrader demonstrates promising efficacy and tolerability in relapsed/refractory NHL
Long-term Breyanzi data confirm durable benefit and high survival rates in LBCL and FL PRINCETON, N.J. / Dec 01, 2025 / Business... Read more
Merck granted Fast Track Designation by the U.S. FDA for MK-2214 for the treatment of Alzheimer's disease RAHWAY, N.J. / Dec 01, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer’s Disease (CTAD) 2025 in San Diego, California from Dec. 1-4. In addition, the company announced that MK-2214, a novel candidate targeting... Read more
Patrick D. Walsh steps down as Chairman and will complete his current term as Board member
Thomas J. Haughey has been unanimously elected to serve as the next Chairman of the Board PRINCETON, N.J., Dec. 01, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced that its Chairman, Patrick D. Walsh, will retire from the Company's Board of Directors after a distinguished tenure of service. His retirement will... Read more
SKYRIZI® (risankizumab), an IL-23 inhibitor, received two consecutive positive reimbursement recommendations by Canada’s Drug Agency (CDA-AMC) for inflammatory bowel diseases, initially for Crohn’s disease (CD) and now for ulcerative colitis (UC), supported by evidence from pivotal phase 3 clinical trials including MOTIVATE, ADVANCE, FORTIFY (for CD), and INSPIRE, COMMAND (for UC).1,2
AbbVie concludes letter of intent (LOI) with the pan-Canadian Pharmaceutical Alliance... Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 27, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology (“ESMO”) Asia Congress 2025, taking place on December 5-7, 2025 in Singapore, and the American Society of Hematology (“ASH”) Annual Meeting taking place... Read more
PARSIPPANY, N.J. / Nov 26, 2025 / Business Wire / Zoetis Inc. today announced that the European Commission has granted the company marketing authorization for Lenivia® (izenivetmab) for the reduction of pain associated with osteoarthritis (OA) in dogs.
Lenivia is a new antibody therapy that reduces OA pain in dogs for three months with one injection through its novel binding properties to nerve growth factor (NGF), recognized as an important mediator of pain and inflammation.... 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
The Company continues working with the third-party manufacturer to address recent FDA follow-up information requests which are required to lift the clinical hold concerning the nebulizer device used in the Phase 2b trial
An independent Data Monitoring Committee (DMC) completed a safety review following adverse events identified in the BX004 Phase 2b trial and recommended that the study continue with revised dosing
Following the DMC review, the study protocol will be... Read more
Following the positive opinions of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorizations for Teva’s biosimilars PONLIMSI and DEGEVMA expanding access to important bone health treatments across Europe
These approvals mark another significant milestone in Teva’s strong biosimilars portfolio, in line with Teva's Pivot to Growth Strategy
The approvals underscore Teva’s commitment to broadening access... Read more
LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start of therapy to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Nov. 25, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher,... Read more
JERSEY CITY, N.J. / Nov 25, 2025 / Business Wire / Organon (NYSE: OGN), announced today that Joe Morrissey, Interim Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3rd, 2025 at 10:00 a.m. ET.
Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at h... Read more
PRINCETON, N.J., Nov. 25, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that Nikhil Lalwani, Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, at 2:00 p.m. ET.
The live and archived fireside chat will be accessible from the Company’s website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations.... Read more
PARSIPPANY, N.J., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Embecta Corp. (“embecta” or the "Company") (Nasdaq: EMBC), a global diabetes care company, today reported financial results for the three- and twelve-month periods ended September 30, 2025.
"Our fourth quarter results were largely in line with our expectations, with revenue lower year over year due to several items we had previously anticipated, including the impact of advanced distributor ordering in the fourth... Read more
In the TRANSCEND MCL trial, 82.7% of patients responded to Breyanzi, with 71.6% of patients achieving complete response
Breyanzi demonstrated sustained clinical benefit, with 50.8% of patients still in response at 24 months based on TRANSCEND MCL trial results PRINCETON, N.J. / Nov 24, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to Breyanzi® (lisocabtagene maraleucel; liso-cel), a C... Read more
Updated results from the Phase 3 EMBER-3 trial for Inluriyo™ (imlunestrant) alone and in combination with Verzenio® (abemaciclib) in ER+, HER2– metastatic breast cancer to be presented as a late-breaking oral presentation
Updated safety and efficacy data to be presented from PIKALO-1, the Phase 1/2 trial of Lilly's pan-mutant-selective PI3Kα inhibitor, which will be advanced into the Phase 3 PIKALO-2 study
New subgroup analysis from the Phase 3 monarchE trial... Read more
THOUSAND OAKS, Calif., Nov. 24, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at Citi's 2025 Global Healthcare Conference at 1:45 p.m. ET on December 3, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to... Read more
THOUSAND OAKS, Calif., Nov. 24, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 8th annual Evercore ISI HealthCONx Conference at 10:00 a.m. ET on December 3, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available... Read more
Results from the BRUIN CLL-314 study comparing Jaypirca (pirtobrutinib) to Imbruvica (ibrutinib) – the first-ever head-to-head Phase 3 study versus a covalent BTK inhibitor to include treatment-naïve CLL/SLL patients – will be presented as an oral presentation
Results from the Phase 3 BRUIN CLL-313 study of pirtobrutinib in patients with treatment-naïve CLL/SLL will be featured as a late-breaking oral presentation
Both BRUIN CLL-314 and BRUIN CLL-313 were selected... Read more
NORTH CHICAGO, Ill., Nov. 24, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3, 2025. Management will participate in a fireside chat at 7:30 a.m. Central time.
A live audio webcast of the presentation will be accessible through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.
About AbbVie
AbbVie's mission... Read more
Oral macrocyclic peptides have the potential to offer biologic-like efficacy and safety in a convenient oral format
Collaboration further advances Biogen’s immunology strategy by broadening its early-stage pipeline and incorporating an additional clinically validated modality into its expanding immunology capabilities CAMBRIDGE, Mass. and TORONTO, Nov. 24, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Dayra Therapeutics today announced a research collaboration... Read more
NASHVILLE, Tenn., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that management will participate in the following two investor conferences in December:
BTIG 5th Annual Ophthalmology Day (Virtual)
Format: Fireside chatDate/Time: Monday, December 1, 2025, at 8:30 AM EST
Piper Sandler 37th Annual Healthcare Conference (New York, NY)
Format: Fireside chatDate/Time:... Read more
PRINCETON, N.J. / Nov 24, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that, following the conclusion of the American Society of Hematology (ASH) Annual Meeting and Exposition, the company will hold a virtual investor event on Thursday, December 11, 2025, to highlight key Hematology programs.
The company will host a webcast beginning at 9:00 a.m. ET, which is accessible here. Company representatives will provide investors and analysts an overview... Read more
First presentation for MK-1045, a novel CD19xCD3 T-cell engager in patients with certain types of leukemia and lymphoma, and for bomedemstat, an LSD1 inhibitor, in patients with polycythemia vera
New data demonstrate continued progress with nemtabrutinib, an investigational non-covalent BTK inhibitor RAHWAY, N.J. / Nov 24, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new data across multiple hematologic... Read more
RANCHO CUCAMONGA, CA / ACCESS Newswire / November 24, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO, and Tony Marrs, EVP of Regulatory Affairs and Clinical Operations, will be participating in an Analyst-Moderated fireside chat at the 37th Annual Piper Sandler Healthcare Conference on Wednesday, December 3rd, 2025, at 2:00 pm ET. For access, visit Amphastar's Pharmaceuticals website at http://ir.amphastar.com. This webcast will... Read more
