Shionogi's S-337395 achieves primary endpoint in Phase II trial for RSV treatment.
European Commission approves Ahzantivebaiama (aflibercept biosimilar) by Formycon, Klinge Biopharma, and Teva.
Lundbeck's Bexicaserin shows positive results in 12-month extension of Pacific trial for DEEs.
Merck's Phase III Hyperion study on Winrevair (sotatercept) for PAH stopped early.
ATH434 Phase II trial shows positive results in early-stage multiple system atrophy patients.
FDA approves update to Qelbree label with new pharmacodynamic data.
FDA approves Ozempic to reduce kidney disease risk in type 2 diabetes patients.
EMA accepts Shingrix prefilled syringe presentation for review.
Neurocrine Biosciences initiates Phase III study of Osavampator for major depressive disorder
EMA accepts Depemokimab for review in asthma with type 2 inflammation.
GSK and Oxford University announce new collaboration for cancer prevention research.
Enhertu approved in the U.S. as the first HER2-directed therapy for HER2-low metastatic breast cancer.
Alkerio Therapeutics reports positive results for Efruxifermin in patients with compensated cirrhosis due to MASH.
Roche's Phase III study shows positive results for PIK3CA-mutated HR+/HER2- breast cancer treatment.
FDA approves Leqembi (lecanemab) IV maintenance dosing for early Alzheimer's disease treatment.
Roche's Elevidys demonstrates significant sustained benefits in Duchenne muscular dystrophy (DMD).
Veru Inc. announces positive topline results from the Phase IIb QUALITY clinical study.
FDA approves Welireg (belzutifan) for advanced unresectable or metastatic pheochromocytoma and paraganglioma.
FDA accepts BLA for RP1 and Opdivo to treat advanced melanoma, submitted by Replimune.
Initiation of Phase III trial of ASP-1929 photoimmunotherapy with Keytruda for head and neck cancer.
Braftovi combination regimen shows improved response in BRAF V600E mutant metastatic colorectal cancer.
Subgroup analysis shows promising outcomes for extra-pancreatic neuroendocrine tumors in GI tract.
Keytruda + Lenvima combo shows improved PFS and ORR but not OS in HER2-negative gastroesophageal cancer trial.
Zanzalintinib alone and with atezolizumab shows positive outcomes in RAS wild-type colorectal cancer trial.
Opdivo + Yervoy combo improves PFS in MSI-H/dMMR metastatic colorectal cancer, outperforming monotherapy.
Amycretin shows significant weight loss in obese patients with weekly subcutaneous administration.
Akero completes enrollment for EFX study in MASH/MASLD patients. Results expected in 2026.
AIM ImmunoTech comments on study linking COVID-19 to increased risk of ME/CFS, highlighting significant findings.
Phase III LEAP-015 trial results show Keytruda and Lenvima effective for HER2-negative gastroesophageal adenocarcinoma.
Valneva’s single-shot Chikungunya vaccine demonstrates positive Phase III results in adolescents.
NICE UK recommends Vafseo for treating symptomatic anemia in CKD dialysis patients.
Results from Nipocalimab Phase III study in generalized myasthenia gravis published.
Study on classic congenital adrenal hyperplasia published in Clinical Endocrinology.
FDA and EMA accept applications for higher dose regimen of nusinersen in SMA.
FDA approves Grafapex for allogeneic stem cell transplantation in AML/MDS patients.
European Commission approves Lazcluze and Rybrevant for first-line treatment of EGFR-mutated NSCLC.
Sarclisa approved in the EU as first anti-CD38 therapy with standard care for multiple myeloma.
European Commission approves Gohibic to treat ARDS patients receiving systemic corticosteroids.
FDA approves Calquence for untreated mantle cell lymphoma patients ineligible for stem cell transplant.
Moderna announces updates on its pandemic influenza program, advancing vaccine development.
Roche receives FDA clearance and CLIA waiver for Cobas Liat tests to diagnose STIs at point of care.
FDA grants supplemental approval for Spravato nasal spray to treat major depressive disorder in adults.
Cytokinetics announces start of AMBER-HFPEF Phase II trial of CK-586 in patients with heart failure
Simcere, Zaiming, and AbbVie partner to develop a novel trispecific antibody candidate for multiple myeloma.
FDA places hold on EBVallo for Epstein-Barr virus and ATA3219 for non-Hodgkin's lymphoma treatment.
EC expands Jemperli (dostarlimab) approval for all adult patients with advanced or recurrent endometrial cancer.
Junshi Biosciences announces commercialization partnership with LEO Pharma for Toripalimab in Europe.
Positive topline results announced for Tivdak (tisotumab vedotin) in the China subpopulation of the Phase III INNOVATV-301 trial.
NMPA China accepts new drug application for KarXT (xanomeline-trospium) for the treatment of schizophrenia.
MHRA UK approves Jeragyo (aprocitentan) to treat resistant hypertension, developed by Idorsia.
NICE updates guidance on Ondexxya (andexanet alfa) for reversing anticoagulation from apixaban or rivaroxaban.
Phase III CONNEX trial in cognitive impairment in schizophrenia fails to meet primary and key secondary endpoints.
Datroway gains U.S. approval for treating metastatic HR-positive, HER2-negative breast cancer in previously treated patients.
FDA approves Lumakras with Vectibix for KRAS G12C-mutated metastatic colorectal cancer.
Novo Nordisk announces positive results from STEP UP trial on subcutaneous semaglutide 7.2 mg for obesity.
FDA approves 9mg and 22mg vials of Niktimvo (axatilimab) for chronic graft-versus-host disease treatment.
FDA approves Calquence with chemoimmunotherapy for untreated mantle cell lymphoma, offering new treatment option.
New data from AF Symposium 2025 highlights Boston Scientific therapies for managing atrial fibrillation patients.
NICE UK approves Agamree (vamorolone) for treating Duchenne muscular dystrophy in patients aged 4 and over.
MHRA UK approves Seladelpar (Livdelzi) for treating primary biliary cholangitis, offering new hope for patients.
Complete analysis of NORSE Eight trial shows promising results for ONS-5010 in treating wet AMD patients.
Submissions to EMA and MHRA completed for Anktiva plus BCG to treat BCG-unresponsive non-muscle invasive bladder cancer.
FDA issues complete response letter for Ebvallo (tabelecleucel) to treat Epstein-Barr virus-positive post-transplant lymphoproliferative disease.
Voluntary halt to all dosing in TROPOS trial of Cibotercept (KER-012) for pulmonary arterial hypertension by Keros Therapeutics.
FDA approves Omvoh (mirikizumab) for Crohn's disease, expanding its use to another major type of IBD by Eli Lilly.
CE Mark approval in EU/UK for BrainSense adaptive deep brain stimulation for Parkinson's by Medtronic.
HyBryte™ treatment for early-stage cutaneous T-cell lymphoma continues to demonstrate positive outcomes.
GSK acquires IDRx Inc. and its potential treatment for first and second-line GIST.
Positive results from Phase III trial of Libtayo in cutaneous squamous cell carcinoma after surgery. Regeneron.
Favorable DSMB review of COVID-19 Phase IIb trial of oral vaccine VXA-CoV2-1 by Vaxart.
First participants randomized in AskBio Phase II gene therapy trial for Parkinson's disease. Bayer.
NMPA China approves Padcev and Keytruda for advanced urothelial cancer. Astellas Pharma.
Johnson & Johnson acquires Intra-Cellular Therapies, expanding its portfolio in innovative therapies.
FDA accepts BLA for Leqembi SC subcutaneous autoinjector for weekly dosing in early Alzheimer's treatment.
BlueRock Therapeutics' Bemdaneprocel advances to Phase III trial for treating Parkinson's disease.
Adaptimmune's Letetresgene Autoleucel receives FDA breakthrough therapy designation for myxoid/round cell liposarcoma.
FDA grants priority review to Datopotamab Deruxtecan for advanced EGFR-mutated NSCLC after prior treatments.
LEO Pharma and Gilead Sciences collaborate to accelerate the development of oral STAT6 programs for treating inflammatory diseases.
FDA mandates new safety warnings for Pfizer’s Abrysvo and GSK’s Arexvy RSV vaccines, highlighting Guillain-Barré syndrome risk.
Johnson & Johnson MedTech’s Dual Energy ThermoCool SmartTouch SF Catheter receives European CE Mark for treating cardiac arrhythmias.
Innate Pharma announces a transformative strategy focused on innovation, ADC development, and partnerships to accelerate growth and deliver new therapies.
Bayer submits applications to FDA and China’s CDE for finerenone, targeting heart failure patients with high unmet medical need.
Pfizer’s sasanlimab, combined with BCG, improves event-free survival in BCG-naïve, high-risk non-muscle invasive bladder cancer patients.
Bayer’s investigational MRI contrast agent, gadoquatrane, meets primary and secondary endpoints in pivotal Phase III studies, showing promising results.
Phase 2a trial supports monthly dosing
NICE UK gives positive guidance for Kimmtrak (tebentafusp) by Immunocore, treating advanced uveal melanoma in HLA-A*02:01-positive adults.
Lilly and Rigel collaborate to develop RIPK1 inhibitors for treating immunological and neurodegenerative diseases, aiming for innovative therapies.
GSK’s Shingrix prefilled syringe presentation accepted for FDA review, offering a convenient option for shingles vaccination. Decision expected by June 2025.
FDA accepts Astellas’ revised sNDA for Izervay, aiming to add positive 2-year clinical trial data to the drug’s label for geographic atrophy treatment.
GSK's B7-H3-targeted ADC, GSK5764227, received FDA Breakthrough Therapy Designation for treating relapsed or refractory osteosarcoma
The European Commission approved Palforzia for toddlers with peanut allergies, making it the first EMA-approved oral immunotherapy for this age group
Verona Pharma's Ohtuvayre (ensifentrine) received FDA approval for COPD maintenance treatment, marking a significant advancement in inhaled therapies
Boston Scientific has acquired Bolt Medical, expanding its cardiovascular treatment portfolio with an advanced intravascular lithotripsy laser-based platform
Galapagos announced plans to split into two publicly traded companies, with one focusing on innovative medicines and the other on cell therapy in oncology
Bayer announced that their Phase III OASIS 4 study showed positive results for a non-hormonal treatment addressing vasomotor symptoms in women undergoing breast cancer therapy
Calico Life Sciences announced that their ALS platform trial with fosigotifator did not meet its primary endpoint of slowing disease progression
The FDA has accepted Agios Pharma's application for a new treatment for adult patients with both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
Bayer has applied for approval in China to use darolutamide, in combination with androgen deprivation therapy, for treating metastatic hormone-sensitive prostate cancer based on positive Phase III trial results
Cassava Sciences announced a 33% workforce reduction and plans to release Phase 3 REFOCUS-ALZ study results for simufilam in early 2025
Acelyrin announced new Phase II data and the Phase III program design for lonigutamab, showing promising efficacy and safety in treating Thyroid Eye Disease
Researchers have identified part of the mechanism by which lecanemab slows Alzheimer's progression, linking it to amyloid-β protofibrils in cerebrospinal fluid
The NMPA has approved Vyloy (zolbetuximab) combined with chemotherapy for treating HER2-negative gastric or GEJ adenocarcinoma with CLDN18.2-positive tumors
The MHRA has granted conditional marketing authorization to Imdylltra (tarlatamab) for treating extensive-stage small cell lung cancer
Santhera Pharmaceuticals and Clinigen Group have signed an agreement to manage the supply and distribution of AGAMREE® (vamorolone) to extend access for patients with Duchenne muscular dystrophy in countries where it is not commercially available
China’s NMPA approves GSK’s Nucala (mepolizumab) for treating adults with chronic rhinosinusitis with nasal polyps, offering a new non-surgical option.
The FDA has accepted Verastem Oncology’s NDA for avutometinib and defactinib to treat recurrent low-grade serous ovarian cancer with KRAS mutation. This combination therapy could become the first FDA-approved treatment specifically for this rare and challenging cancer.
The Phase III KOASTAL-1 study of navacaprant for major depressive disorder did not show statistically significant improvement in depressive symptoms compared to placebo. Despite the setback, Neumora Therapeutics remains committed to further analyzing the data and continuing their research.
Altamira Therapeutics successfully tested its nanoparticle-based delivery platform for circular RNA, showing higher protein expression than linear mRNA
Veru has sold its FC2 Female Condom business for $18 million to focus on developing its biopharmaceutical pipeline, particularly enobosarm
The FDA has accepted Nuvation Bio's NDA for taletrectinib to treat advanced ROS1-positive NSCLC, with a PDUFA date set for June 23, 2025
The European Commission has approved Yselty (linzagolix) for the symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment
Chenodal has received FDA approval for medical necessity in treating cerebrotendinous xanthomatosis (CTX), a rare cholesterol metabolism disorder. This approval by Mirum Therapeutics marks a significant step in providing effective treatment for CTX patients.
