Conditional Approval Marks Elanco's Third New World Screwworm Treatment Option for Companion Animals, Providing Multiple Treatment Solutions Prior to Fly Being Detected in the U.S. FDA's Conditional Approval of Credelio Quattro-CA1 (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is the first for companion animals against New World screwworm
Action follows previous Emergency Use Authorizations granted by the FDA for Credelio™ (lotilaner)... Read more
TRUFILL n-BCA is now indicated for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and Chronic Subdural Hematoma (cSDH) as an adjunct to surgery.
Approval builds on a trusted solution in neurovascular embolization for over 25 years. IRVINE, Calif., Dec. 18, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Today, Johnson & Johnson MedTech, a leader in neurovascular care, announced that the U.S. Food and... Read more
WARREN, N.J., Dec. 18, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that CEO Matthew B. Klein, M.D., will present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, Jan. 12, 2026, at 9 a.m. PST/12 p.m. EST.
The presentation will be webcast live on the Events and Presentations page of the Investors section of the PTC Therapeutics website at https://ir.ptcbio.com/events-presentations, and it will be archived for 30 days... Read more
MONTREAL, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved WYNZORA®, a white uniform cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12-17 years for up to 8 weeks.1
Knight obtained the Canadian... Read more
Receives U.S. Food and Drug Administration (FDA) Approval for Generic Version of Sandostatin® LAR Depot (Octreotide Acetate for Injectable Suspension)
U.S. FDA Accepts New Drug Application for Low Dose Estrogen Weekly Patch for Contraception
U.S. FDA Clears Investigational New Drug Application for MR-146 in Neurotrophic Keratopathy
Japan Pharmaceuticals and Medical Devices Agency Accepts Japanese New Drug Application Filing for Pitolisant in Obstructive Sleep Apnea... Read more
Data expected in Q2 2026 DUBLIN, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH).
REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal,... Read more
In ATTAIN-MAINTAIN, orforglipron achieved the primary and all key secondary endpoints for weight maintenance vs. placebo at 52 weeks following weight loss on Wegovy or Zepbound
Participants who switched to orforglipron from Wegovy maintained all but 0.9 kg of their previously achieved weight loss on average
Lilly has submitted orforglipron to the U.S. Food and Drug Administration for the treatment of obesity INDIANAPOLIS, Dec. 18, 2025 /PRNewswire/ -- Eli Lilly and... Read more
Pivotal Phase 3 studies of once-daily oral zasocitinib met all primary and ranked secondary endpoints in patients with moderate-to-severe plaque psoriasis
More than half of study participants treated with zasocitinib achieved clear or almost clear skin (PASI 90), and on average about 30 percent achieved completely clear skin (PASI 100) by week 16
Zasocitinib was generally well-tolerated with a safety profile consistent with previous clinical studies OSAKA, Japan &... Read more
Jack Bendheim to Assume the Role of Executive Chairman; Daniel Bendheim Named Chief Executive Officer and President TEANECK, N.J. / Dec 18, 2025 / Business Wire / Phibro Animal Health Corporation (Nasdaq: PAHC) (the “Company” or “Phibro”) today announced a leadership transition that will support the Company’s continued growth and long-term strategic direction. At the end of this fiscal year, effective July 1, 2026, Jack Bendheim, current Chairman, Chief Executive... Read more
FOSTER CITY, Calif. / Dec 18, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) announced today that Keeley Wettan will be appointed Executive Vice President, General Counsel, Legal & Compliance effective immediately. She will join the company’s senior leadership team and report to Chairman and Chief Executive Officer Daniel O’Day.
Ms. Wettan has held increasingly senior legal leadership roles within Gilead during her 14-year tenure, most recently as Senior... Read more
RYBREVANT FASPRO™, the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, reduces administration time from hours to minutes and significantly reduces administration-related reactions1-5
Approval builds on previously reported Phase 3 MARIPOSA data showing unmatched overall survival benefit of this chemotherapy-free regimen, projected to exceed four years6 HORSHAM, Pa., Dec. 17, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced... Read more
Both monthly maintenance doses (100 mg and 300 mg) improved opioid abstinence and were well-tolerated with no new safety signals identified.
Post-hoc analyses indicated the 300-mg monthly maintenance dose performed significantly better than the 100-mg monthly dose in participants reporting high-frequency fentanyl use. RICHMOND, Va., Dec. 17, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) today announced results from a randomized, double-blin... Read more
Agreement Calls for Development Services and Tech Transfer in Preparation for Commercial Manufacturing of Injectable Pharmaceutical Product
Partner’s Program Size Positions it to Become a Top Five Commercial Customer for Lifecore CHASKA, Minn., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore”), a fully integrated contract development and manufacturing organization (“CDMO”), today announced that it has signed a CDMO master... Read more
PITTSBURGH, Dec. 17, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the Company will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, Jan. 13, 2026. The Company's presentation and fireside chat will begin at 9 a.m. PT / 12 p.m. ET.
A live webcast of the event can be found at investor.viatris.com. An archived version of the presentation will be available following the... Read more
PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients with muscle-invasive bladder cancer
Positive EV-304 data, combined with the recent unprecedented results from the EV-303 trial, highlight the potential of this combination to become a new platinum-free standard of care in an earlier stage of bladder cancer
Results from the... Read more
First and only immunotherapy plus ADC regimen, used perioperatively, to extend survival for cisplatin-eligible patients with MIBC RAHWAY, N.J. / Dec 17, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial showed KEYTRUDA®... Read more
Following positive efficacy and safety results from Phase 2b QUALITY study, company received FDA regulatory clarity for enobosarm in combination with GLP-1 RA
Incremental weight loss is an acceptable approvable primary endpoint with key secondary endpoints on physical function and body composition improvements
Company plans to initiate Phase 2 PLATEAU clinical study in calendar Q1 2026
Post fiscal year end, company completed public offering for net... Read more
Exdensur is the first and only ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype
Approval based on SWIFT trials showing significantly lower rate of annualized asthma exacerbations in patients receiving depemokimab versus placebo
SWIFT data included reduction in exacerbations requiring hospitalization and/or emergency department visits with depemokimab
An estimated 2 million Americans live with... Read more
First-in-human trial of candidate from the next-generation ATTC platform
Simultaneous China and global clinical development strategy to expedite development process HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 17, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the initiation of its global Phase I clinical development program for HMPL-A251, a first-in-class PI3K/PIKK-HER2 Antibody-Targeted Therapy... Read more
The new cobas® 6800/8800 Systems version 2.0 and software version 2.0.1 enhances throughput, run flexibility, enables sample prioritization and is available as an upgrade to existing systems.
Laboratories can now perform a greater variety of tests per run, simplifying laboratory logistics and helping to optimize the use of resources.
The update addresses critical industry challenges, such as staffing shortages, rising costs and menu fragmentation, while optimizing... Read more
TORONTO, Dec. 16, 2025 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that FRUZAQLATM (fruquintinib capsules) will now be reimbursed by BC Cancer as a treatment option for adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates, for available standard therapies.[1] This treatment is available to patients under certain criteria.
"Colorectal cancer remains the second leading cause... Read more
Continued Investment in Pipeline and Acquired Assets in 2026 to Fuel Long-Term Growth
Reaffirms Full-Year 2025 Adjusted(1) Diluted EPS Guidance(2) and Revises Full-Year 2025 Revenue Guidance(2) to Approximately $62.0 Billion
Full-Year 2026 Revenue Guidance(2) Range of $59.5 to $62.5 Billion
Full-Year 2026 Adjusted(1) Diluted EPS Guidance(2) Range of $2.80 to $3.00 NEW YORK / Dec 16, 2025 / Business Wire / Pfizer Inc. (NYSE:PFE) today provided its full-year 2026 guidance(2)... Read more
Based on DESTINY-Breast09 Phase III trial results that showed AstraZeneca and Daiichi Sankyo’s ENHERTU in combination with pertuzumab reduced the risk of disease progression or death by 44% vs. THP with a median progression-free survival of more than three years WILMINGTON, Del. / Dec 15, 2025 / Business Wire / AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been approved in the US for the 1st-line treatment... Read more
Clinical Development Program Appropriate for Rolling BLA
Submission Expected by the End of 2025 CANTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the successful completion of a planned Type-B meeting with the Food... Read more
Investigational Treatment Regimen Could Expand Options for Virologically Suppressed Adults
Positive Phase 3 Results from Both ARTISTRY-2 and ARTISTRY-1 Trials will Form the Basis of Regulatory Submissions FOSTER CITY, Calif. / Dec 15, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ARTISTRY-2 trial. The double-blind trial evaluated the treatment responses of adults with HIV who are vi... Read more
RANCHO CUCAMONGA, CA / ACCESS Newswire / December 15, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen. The FDA determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO®.
"We are proud to announce... Read more
Expanded indication for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone marks the first FDA-approved precision medicine combination treatment for patients with BRCA2-mutated mCSPC HORSHAM, Pa., Dec. 12, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for AKEEGA® (niraparib and abiraterone acetate dual-action... Read more
As monotherapy, imlunestrant demonstrated an 11.4-month numeric improvement in median OS versus endocrine therapy in patients with ESR1-mutated disease
In all patients, the imlunestrant plus abemaciclib combination achieved a median PFS of 10.9 months, demonstrated a favorable OS trend, and extended time to chemotherapy by more than a year
These data were published simultaneously in Annals of Oncology and will be presented today at the 2025 San Antonio Breast Cancer... Read more
RAHWAY, N.J. / Dec 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of an expanded indication for WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV... Read more
GAITHERSBURG, Md., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for its Winnipeg, Canada facility to be added as the drug product manufacturing and testing site for raxibacumab, a monoclonal antibody for the treatment and prophylaxis of inhalational anthrax.
“We are pleased with the U.S. FDA approval of our sBLA for... Read more
UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing*
First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and anti-MuSK Ab+ gMG THOUSAND OAKS, Calif., Dec. 11, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and... Read more
The U.S. FDA assigned a target action date of April 8, 2026 PRINCETON, N.J. / Dec 11, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and older) patients with previously untreated... Read more
In TRIUMPH-4, participants with obesity and knee osteoarthritis taking retatrutide 12 mg lost an average of 28.7% of their body weight at 68 weeks
Retatrutide reduced WOMAC pain scores by up to an average of 4.5 points (75.8%) and significantly improved measures of physical function, with more than 1 out of 8 retatrutide-treated patients completely free from knee pain at the end of the trial
Seven additional Phase 3 trials evaluating the investigational... Read more
Clinical trial achieved all three primary objectives with no significant safety issues being reported
Results indicate that Emrosi can be safely used for up to 16 weeks with no detectable impact on skin, GI tract or vaginal microbiota
FDA-approved Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) is available in the United States for the treatment of inflammatory lesions of rosacea in adults SCOTTSDALE,... Read more
R&D assessment shows the platform can incorporate different drug entities onto its sustained-release matrix, supporting long-term potential to reduce or eliminate reliance on medicated eye drops TEL AVIV, Israel, Dec. 10, 2025 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) today announced that its pharmaceutical division has completed an R&D assessment of LayerBio’s proprietary drop-less, sustained-release ocular drug-delivery platform. The assessment... Read more
Giredestrant is the only oral SERD to show superior invasive disease-free survival in the adjuvant setting, marking the first significant endocrine therapy advance in over 20 years
Transformational results support the potential of giredestrant to become a new standard-of-care for early-stage disease
ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and up to a third experience recurrence on or after adjuvant endocrine therapy... Read more
TUKYSA, trastuzumab, and pertuzumab reduced the risk of disease progression or death by 36% compared to trastuzumab and pertuzumab alone in Phase 3 HER2CLIMB-05 study
The combination demonstrated a manageable safety profile as a first-line maintenance therapy NEW YORK / Dec 10, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced detailed results from the Phase 3 HER2CLIMB-05 trial of the tyrosine kinase inhibitor TUKYSA® (tucatinib) as part of an investigational... Read more
U.S. Losartan market totals $245M annually with 71M prescriptions COMMACK, NY, Dec. 10, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, and Blink Rx LLC (“BlinkRx”),... Read more
Broad label includes all age groups and full range of PKU subtypes TORONTO, Dec. 10, 2025 /CNW/ - PTC Therapeutics Canada ULC announced that Health Canada has approved Sephience™ (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). The approval includes broad labeling for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month old and older with sepiapterin-responsive PKU.
"We're pleased with... Read more
MELBOURNE, Australia and PALO ALTO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces a strategic clinical collaboration with Varian, a Siemens Healthineers company and global leader in radiation oncology, to develop novel clinical applications that combine Telix’s theranostic products and external beam radiation therapy (EBRT).
EBRT is a widely used and validated treatment suitable for most solid... 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
Huntsville site will focus on domestic production of small molecule synthetic and peptide medicines, including Lilly's oral GLP-1, orforglipron
Company plans to create 3,450 manufacturing and construction jobs at Lilly's ninth U.S. manufacturing site announced since 2020 INDIANAPOLIS, Dec. 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced plans to invest more than $6 billion in a new manufacturing facility in Huntsville, Alabama. This... Read more
Olanzapine long-acting injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation, for a broad patient population1
Olanzapine LAI is designed to help support real-world adherence and improved stability, with the goal of addressing a critical treatment gap for people living with schizophrenia1
Teva is committed to advancing this innovative treatment option and further build on its differentiated LAI franchise... Read more
TECVAYLI® and DARZALEX FASPRO® combination led to a statistically significant progression-free survival and overall survival advantage compared to standard treatment after three years of follow-up
Combination regimen granted Breakthrough Therapy Designation by U.S. FDA ORLANDO, Fla., Dec. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma, today announced new data from the investigational Phase 3 MajesTEC-3 study... Read more
The risk reduction observed in BRUIN CLL-313 is among the most compelling observed for a single agent BTK inhibitor in a front-line CLL study
These data will be simultaneously published in the Journal of Clinical Oncology and highlighted in a late-breaking oral presentation at the 2025 American Society of Hematology Annual Meeting and Exposition, and were featured as part of the meeting's press program INDIANAPOLIS, Dec. 9, 2025... Read more
Augments Pfizer’s efforts to advance investigational medicines for cardiometabolic diseases NEW YORK / Dec 09, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced it has entered into an exclusive global collaboration and license agreement with YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Limited (02196.HK and 600106.SH), a leading innovation-driven global healthcare company, for the development, manufacturing and commercialization... Read more
Lunsumio in combination with lenalidomide may offer an effective treatment in relapsed or refractory follicular lymphoma based on first data from single-arm cohort of Phase III CELESTIMO study
Data from subcutaneous Lunsumio plus Polivy reinforce its outpatient, chemotherapy-free potential in people with R/R large B-cell lymphoma
Results highlight the potential of innovative Lunsumio combination regimens to offer improved outcomes for more people with lymphoma... Read more
PRINCETON, N.J. / Dec 08, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) reinforces its hematology leadership through new research across multiple therapies for patients with lymphoma at the 67th American Society of Hematology (ASH) Annual Meeting.
Highlights include updates from the company’s targeted protein degradation pipeline, including data on first-in-class investigational lymphoma CELMoD™ agent golcadomide and first-in-class BCL6 ligand-directed degrader... Read more
INDIANAPOLIS, Dec. 8, 2025 /PRNewswire/ -- The board of directors of Eli Lilly and Company (NYSE: LLY) elected Carolyn R. Bertozzi, Ph.D., as a returning member, effective Dec. 8, 2025. She will serve on the board's Science and Technology and Ethics and Compliance committees.
"On behalf of Lilly and the entire board, I would like to welcome Carolyn back to Lilly," said David A. Ricks, Lilly chair and CEO. "Carolyn is a Nobel Prize-winning chemist whose work has fundamentally... Read more
NASHVILLE, Tenn., Dec. 8, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), today announced an important update regarding its Caldolor® (ibuprofen) Injection. The product's permanent J-code, J1741, is now officially associated with a reimbursement price, providing healthcare providers with a CMS-covered, non-opioid option for managing pain and fever.
As the nation continues to face an opioid crisis, non-opioid alternatives, like Caldolor, play a critical... Read more
