PARSIPPANY, N.J. / Sep 12, 2025 / Business Wire / Zoetis Inc. today announced that the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of marketing authorization for Portela® (relfovetmab), a new monoclonal antibody (mAb) therapy intended for the alleviation of pain associated with osteoarthritis (OA) in cats.
Portela Will Be First Long-Acting Anti-NGF mAb Therapy for Cats,... Read more
MONTREAL, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, is pleased to announce that its shareholders have approved the previously announced plan of arrangement (the “Arrangement”) under Chapter XVI – Division II of the Business Corporations Act (Québec) involving CB Biotechnology, LLC (the “Purchaser”),... Read more
SKNY transaction strengthens MIRA pipeline with SKNY-1, a differentiated oral candidate that has demonstrated up to 30% weight loss and nicotine craving reversal in preclinical studies. MIAMI, FL / ACCESS Newswire / September 12, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that its... Read more
The transaction adds larsucosterol, an FDA Breakthrough Therapy for alcohol-associated hepatitis with a registrational Phase 3 clinical trial in development, to Bausch Health's hepatology pipeline LAVAL, QC, AND CUPERTINO, CA / ACCESS Newswire / September 11, 2025 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) ("Bausch Health"), a global, diversified pharmaceutical company, today announced the successful completion of its previously announced tender offer to acquire... 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
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Cosmos Health Inc. (“Cosmos Health” or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today announced that its wholly owned subsidiary, Sky Pharm SA, signed a distribution agreement (the “Agreement”) with Scientific Pharmacy LLC (“Scientific Pharmacy”) for its Sky Premium Life food supplement products in Oman.
Scientific Pharmacy, the retail and wholesale... Read more
Results from the Phase 3 STRIDE-13 trial presented at the 6th ESCMID Conference on Vaccines
Merck to share STRIDE-13 results with global regulatory authorities RAHWAY, N.J. / Sep 11, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th European Society of Clinical Microbiology and Infectious... Read more
Rhonda Pacheco to Succeed Julie Kim, Who Was Appointed to Be Takeda’s Next CEO CAMBRIDGE, Mass. / Sep 11, 2025 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that Rhonda Pacheco, most recently group vice president of U.S. Cardiometabolic Health at Eli Lilly, will join Takeda, effective September 29, as president of Takeda’s U.S. Business Unit and will be a member of the Takeda Executive Team. Pacheco will succeed Julie Kim, who was appointed by the... Read more
BEIJING, Sept. 10, 2025 /PRNewswire/ -- Shineco Inc. (NASDAQ: SISI) ("Shineco" or the "Company"), a leading developer of induced pluripotent stem cell (iPSC) technology platforms, today announced that its subsidiary, Fuzhou Meidashan Biotechnology Co., Ltd., has successfully achieved large-scale production of high-purity, highly active free-form soybean phospholipids. This breakthrough was made possible through its proprietary APCC-UF pure physical extraction... Read more
Transformation to increase speed and redirect resources to growth opportunities within diabetes and obesity, aiming at reaching millions of untreated patients
Intention to reduce ~9,000 roles globally with the expectation to deliver DKK 8bn of annualised savings by the end of 2026
One-off restructuring costs of DKK 8bn leading to an updated full-year 2025 operating profit growth outlook of 4–10% at CER Bagsværd, Denmark, 10 September 2025 – Novo Nordisk today... Read more
Poster presentation will feature new data for SYMPAZAN, the only FDA-approved oral film formulation of clobazam for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older
Abstract is now available on ANA2025 website LAKE FOREST, Ill., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities... Read more
Agreement strengthens Canadian veterinarians' access to Zomedica's advanced therapeutic and monitoring solutions ANN ARBOR, MI / ACCESS Newswire / September 10, 2025 / Zomedica Corp. (OTCQB:ZOMDF), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, announced today that it has expanded its distribution agreement with UXR Inc., a leading Canadian animal health company focused on supporting the needs... Read more
VANCOUVER, B.C. / ACCESS Newswire / September 9, 2025 / Lobe Sciences Ltd. ("Lobe" or the "Company") (CSE:LOBE)(OTCQB:LOBEF)(FWB:LOBE.F) a clinical stage biopharmaceutical company focused on developing products to treat diseases with significant unmet medical needs is pleased to announce its participation in the upcoming Clusterbusters 20th Annual U.S. Patient Conference taking place September 11-14, 2025, in Grapevine, Texas (near Dallas/Ft. Worth).
This conference is... Read more
MELBOURNE, Australia and INDIANAPOLIS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis.
BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study1) is the first regi... Read more
First and only drug releasing system to provide extended local delivery of a cancer medication into the bladder, with 82 percent of patients achieving complete response without the need for reinduction1
Potential practice-changing treatment for certain patients with BCG-unresponsive non-muscle invasive bladder cancer who have limited options before possible bladder removal RARITAN, N.J., Sept. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today... Read more
Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development.
New therapeutic options for people living with MSA, a rare and devastating neurodegenerative disorder, are urgently needed as there are no treatments available that impact disease progression.
Emrusolmin is a small molecule that targets the alpha synuclein protein, which is... Read more
Program provides access to Lilly-trained artificial intelligence to help accelerate breakthrough medicines
New offering expands Lilly Catalyze360's support for early-stage drug development INDIANAPOLIS, Sept. 9, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the launch of Lilly TuneLab, an artificial intelligence and machine learning (AI/ML) platform that provides biotech companies access to drug discovery models trained on years of Lilly's... Read more
VANCOUVER, BC / ACCESS Newswire / September 8, 2025 / Lobe Sciences Ltd. ("Lobe Sciences" or the "Company") (CSE:LOBE) (OTCQB:LOBEF) (FWB:LOBE.F) a clinical stage biopharmaceutical company focused on developing products to treat diseases with significant unmet medical needs is pleased to announce the appointment of Mr. Marco Mastrodonato to the Company's Board of Directors.
Mr. Mastrodonato brings extensive leadership and international business development experience in... Read more
THOUSAND OAKS, Calif. and TOKYO, Sept. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD).
The ongoing ASCEND study, which includes approximately 2,600 patients, is designed to evaluate... Read more
NEW BRUNSWICK, N.J. / Sep 08, 2025 / Business Wire / Johnson & Johnson (NYSE: JNJ) announced today that John Morikis, retired Chairman, President and Chief Executive Officer of The Sherwin-Williams Company, has been elected to its Board of Directors.
“We are pleased to welcome John to our Company’s Board of Directors,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “He is a proven leader of a large multinational organization... Read more
Announces Commitment for New $40 Million Revolving Credit Facility
Issues Conditional Notice of Redemption of 11.875% Senior Notes due 2027 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that it has commenced a private offering (the “Offering”) of $250.0 million aggregate principal amount of senior unsecured notes due 2030... Read more
In the Phase 3 BRUIN CLL-313 study, treatment with pirtobrutinib demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival versus bendamustine plus rituximab, indicating one of the most compelling effect sizes ever observed for a single agent BTK inhibitor in a front-line CLL study
BRUIN CLL-313 is the third positive Phase 3 study from the pirtobrutinib development program in CLL
Results from BRUIN CLL-313... Read more
Phase 3 clinical trial cohort of adults 65+ and 18-64 with at least one underlying risk condition shows at least a 4-fold increase in LP.8.1-neutralizing antibody titers after receiving the LP.8.1-adapted COVID-19 vaccine 2025-2026 Formula
First LP.8.1 sublineage clinical findings reinforce pre-clinical data supporting recent FDA approval of 2025-2026 Formula of Pfizer-BioNTech COVID-19 Vaccine
Companies have submitted these data to the FDA NEW YORK & MAINZ, Germany... Read more
Takeda is the Leader in Orexin Science and is on Track to Submit Global Regulatory Applications Starting in Fiscal Year 2025
Four Orexin Oral Presentations from Phase 3 Pivotal Studies Highlight Statistically Significant and Clinically Meaningful Improvement in Narcolepsy Type 1 Symptoms Demonstrating the Potential for a New Era of Care
Oveporexton was Generally Well-Tolerated with Safety Profile Consistent with Previous Clinical Studies SINGAPORE & OSAKA, Japan... Read more
CorMedix is making a strategic investment in Talphera as the lead investor, supported by existing stockholders Nantahala, Rosalind and Rock Springs with several new institutional investors
$17 million in proceeds at first closing with the potential to receive an additional $12 million across one additional tranche upon the achievement of the primary endpoint in the NEPHRO clinical study
The completion of this financing is expected to provide the company with sufficient... Read more
Vancouver, British Columbia--(Newsfile Corp. - September 8, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company") a Canadian drug manufacturer of MDMA and naturally-derived psilocybin announces that it has publicly filed a registration statement with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed initial public offering of its common shares in the United States.
The number of common shares to be sold... Read more
An objective response rate of 48.2% was observed with ifinatamab deruxtecan in these previously treated patients
Discussions with global regulatory authorities underway BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 07, 2025 / Business Wire / Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). These... Read more
FLAURA2 final overall survival analysis reinforces the favorable benefit-risk profile of this combination
Results underscore TAGRISSO as 1st-line standard of care and backbone therapy in EGFRm lung cancer across stages WILMINGTON, Del. / Sep 07, 2025 / Business Wire / Positive results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy... Read more
Chemotherapy-free combination regimen ushers in new era for first-line treatment, with overall survival projected to exceed four years, surpassing monotherapy TKI osimertinib by more than one year RARITAN, N.J., Sept. 7, 2025 /PR Newswire/ – Johnson & Johnson (NYSE: JNJ) today announced The New England Journal of Medicine (NEJM) published results from the Phase 3 MARIPOSA study, which showed RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) demonstrated... Read more
RYBREVANT® combination extends survival and significantly reduces common EGFR and MET resistance mutations seen with osimertinib-based treatment BARCELONA, Spain, Sept. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new analyses from the Phase 3 MARIPOSA study showing that first-line treatment with RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE® (lazertinib) significantly reduces the development of epidermal growth factor receptor (EGFR)-... 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
17 abstracts accepted, including one oral presentation
Data from the REFRESH real-world study highlight efficacy of once-nightly sodium oxybate when switching from twice-nightly oxybates
REFRESH study also highlights efficacy in those who were new to oxybate or returning to oxybate after discontinuing twice-nightly oxybate DUBLIN, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines... Read more
EGRIFTA WR™ offers convenience of weekly reconstitution and reduced daily injection volume, compared to EGRIFTA SV®
Specialty pharmacies are now ordering EGRIFTA WR™ to fill prescriptions MONTREAL, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today announced the availability of EGRIFTA WR™ (tesamorelin) for injection for the reduction... Read more
The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in the assessment of HER2-ultralow status to identify metastatic breast cancer patients who may be eligible for treatment with ENHERTU.
The VENTANA HER2 (4B5) test is also now approved to help identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA.
Roche continues to break ground as the leader in breast cancer... Read more
In AVONELLE-X, the largest long-term extension trial in wet AMD, disease control and durability were maintained over 4 years, with nearly 80% of patients on extended dosing by study end
Over 60% of people with a difficult-to-treat form of wet AMD showed no signs of damaging lesions in the SALWEEN study, and clinically meaningful vision improvements were observed
Vabysmo was well tolerated with a consistent long-term safety profile in wet AMD in both studies SOUTH SAN... Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 05, 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 2025 World Conference on Lung Cancer (“WCLC”) taking place on September 6-9, 2025 in Barcelona, Spain, and the Chinese Society of Clinical Oncology (“CSCO”) Annual Meeting 2025, taking place... Read more
THOUSAND OAKS, Calif., Sept. 4, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Morgan Stanley 23rd Annual Global Healthcare Conference at 9:15 a.m. ET on September 9, 2025. Peter Griffith, executive vice president and chief financial officer at Amgen, and Kave Niksefat, senior vice president of Global Marketing and Access at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously... 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
PALO ALTO, Calif, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Semnur Pharmaceuticals, Inc. (“Semnur”), a majority-owned subsidiary of Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and neurodegenerative and cardiometabolic disease, today announced that the shareholders of Denali... Read more
Oral presentation will feature data demonstrating SCY-247 in vitro activity against C. auris strains, including isolates with mutations commonly associated with echinocandin-resistance
Additional poster presentations highlight SCY-247’s broad spectrum of antifungal activity, against Candida species, including multidrug- and pandrug-resistant C. auris and Aspergillus species
Company anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)... Read more
The Breakthrough Therapy designation for olomorasib is based on data from the Phase 1/2 LOXO-RAS-20001 trial and Phase 3 SUNRAY-01 trial
Updated efficacy and safety data for olomorasib will be presented at the IASLC 2025 World Conference on Lung Cancer INDIANAPOLIS, Sept. 4, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combination... Read more
Expands Avadel’s pipeline with salt-free, artificial sweetener-free, once-at-bedtime oxybate for treatment of narcolepsy and idiopathic hypersomnia
Initial pharmacokinetic (PK) and comparative bioavailability study to initiate in fourth quarter 2025 with pivotal PK trial planned for second half 2026
XWPharma to receive $20 million upfront; potential for development, regulatory and sales milestone payments in addition to royalties on future net sales&n... Read more
New Bay Area Building Marks Significant Progress as Part of $32 Billion U.S. Investment Projected to Create $43 Billion in Economic Value FOSTER CITY, Calif. / Sep 03, 2025 / Business Wire / Gilead Sciences (Nasdaq: GILD) today celebrates the groundbreaking of its new Pharmaceutical Development and Manufacturing (PDM) Technical Development Center (NTDC) at the company’s Foster City headquarters. This milestone marks continued momentum in Gilead’s multi-year strategy... Read more
Data presented at 13th Society of Hematologic Oncology (SOHO) Annual Meeting NORTH CHICAGO, Ill., Sept. 3, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 2 EPCORE® NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with relapse... Read more
LAKE FOREST, Ill., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT) announced that members of its management team will host investor meetings at two investor conferences in New York City during September 2025.
Company management will host investor meetings at the HC Wainwright Conference on Wednesday, September 10, 2025, taking place at the Lotte New York Palace Hotel. Investors can register and request meetings... Read more
Export of 1,000 natural psilocybin capsules for prescription use under Australia's Authorised Prescriber Scheme follows the Company's successful launch of MDMA sales in 2024 Vancouver, British Columbia--(Newsfile Corp. - September 3, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian manufacturer of GMP psychedelic medicines, is pleased to announce the commercial launch of its natural psilocybin capsules in Australia,... Read more
Agreement to explore Argo's Phase 2 ANGPTL3 in a combination trial in dyslipidemia with an option to license second-generation molecules in the pipeline
License to an additional Argo siRNA candidate currently in IND-enabling studies
Argo will receive an upfront payment of $160 million, an option for Profit & Loss split across multiple geographies and potential near-term equity; Argo is also eligible to receive option payment, development, sales milestones and royalties... Read more
Strategic partnership with Pioneer Veterinary Products Limited expands Zomedica's presence in the UK veterinary market through distribution of its leading point-of-care solutions ANN ARBOR, MI / ACCESS Newswire / September 3, 2025 / Zomedica Corp. (OTCQB:ZOMDF) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostic and therapeutic products for equine and companion animals, today announced a new distribution partnership in the United... Read more
