TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test
The U.S. Food and Drug Administration has granted Breakthrough Device Designation to TOBY’s urine‑based test for Alzheimer’s disease, targeting adults aged 50 and older with cognitive impairment. The test analyzes volatile organic compound patterns in urine using mass spectrometry and proprietary machine‑learning algorithms. This designation broadens TOBY’s portfolio beyond oncology into neurodegenerative diagnostics and paves the way for further clinical validation and future regulatory submissions. The company will continue collaborating with the FDA to advance the assay toward market clearance.
Sobi Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at EAS 2026
Sobi presented pooled Phase III data from its CORE and CORE2 trials, evaluating the antisense drug olezarsen (Tryngolza) in 455 patients with severe hypertriglyceridemia (TG ≥ 500 mg/dL). At six months, the 80 mg dose cut triglycerides by 66% and the 50 mg dose by 59%...
Merz Therapeutics and Kvvit Partner to Advance Inbrija in Mainland China, Hong Kong and Macao
Merz Therapeutics has licensed its inhaled levodopa product Inbrija to Chinese biotech Kvvit for exclusive commercialization in mainland China, Hong Kong and Macao. The agreement assigns Merz responsibility for drug supply, global quality oversight and holding the overseas registration certificate,...
Olympus to Acquire BioProtect for ~$270M
Olympus announced a definitive agreement to acquire BioProtect for approximately $270 million, targeting the company’s Balloon Spacer system that safeguards healthy tissue during prostate cancer radiotherapy. The transaction includes escrow provisions tied to uninterrupted business operations, with closing slated for the...
Oticon Medical Launches Ponto Instant Portfolio to Expand Non-Surgical Bone Conduction Hearing Options
Oticon Medical unveiled the Ponto Instant portfolio, a non‑surgical bone‑conduction hearing solution that adds two new wearables: the Instant HearBand and the Instant SoundConnector. The HearBand offers a lightweight, behind‑the‑head design with adjustable sizing, while the SoundConnector lets users attach...
AstraZeneca Receives the CHMP Positive Opinion for Camizestrant to Treat Advanced Breast Cancer
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be used with a CDK4/6 inhibitor for ER‑positive, HER2‑negative advanced breast cancer harboring ESR1 mutations....
Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia
The European Commission has granted approval for Agios' oral pyruvate kinase activator Pyrukynd (mitapivat) to treat anemia in adults with both non‑transfusion‑dependent and transfusion‑dependent alpha‑ or beta‑thalassemia. The decision follows positive results from the global Phase III ENERGIZE and ENERGIZE‑T trials,...
Pharming Reports the EC Approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)
The European Commission has granted marketing authorization for Pharming’s oral PI3Kδ inhibitor Joenja (leniolisib) to treat patients aged 12 and older with activated phosphoinositide 3‑kinase delta syndrome (APDS) across all 30 EEA states. Approval is based on a Phase II/III...
Gilead Reports the US FDA Accelerated Approval of Hepcludex to Treat Chronic Hepatitis Delta Virus (HDV) Infection
Gilead Sciences received accelerated approval from the U.S. Food and Drug Administration for Hepcludex (bulevirtide‑gmod), an 8.5 mg subcutaneous injection for adults with chronic hepatitis delta virus (HDV) infection. The decision is based on data from the Phase III MYR301 trial, which...
The NMPA Grants Conditional Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC
China's National Medical Products Administration granted conditional approval to Boehringer Ingelheim’s oral HER2‑mutant NSCLC drug Hernexeos (zongertinib). The decision is based on a Phase Ib trial of 74 treatment‑naïve patients that delivered a 75.7% overall response rate and a median...
Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Astellas’ Padcev (enfortumab vedotin) combined with Keytruda (pembrolizumab) for neoadjuvant and adjuvant treatment of cisplatin‑ineligible patients with resectable muscle‑invasive bladder cancer (MIBC). The...
Tempus AI Launches ArteraAI Prostate Test for Metastatic Prostate Cancer
Tempus AI announced the clinical launch of the ArteraAI Prostate Test, a CLIA‑certified and CAP‑accredited prognostic assay for metastatic hormone‑sensitive prostate cancer (mHSPC). The test combines a digital pathology AI algorithm with Tempus’ next‑generation sequencing data to generate personalized risk...
Allergan Aesthetics (AbbVie) Reports CHMP Positive Opinion for Boey to Temporarily Improve Glabellar Lines in Adults
Allergan Aesthetics, a unit of AbbVie, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending Boey (trenibotulinumtoxinE) for the temporary improvement of moderate-to-severe glabellar lines in adults. The recommendation covers all...
Polpharma Partners with Tuteur to Commercialize a Biosimilar Candidate Across LATAM for Autoimmune Diseases
Polpharma Biologics has signed a licensing deal with Tuteur to bring a biosimilar candidate for autoimmune diseases to Latin America, excluding Brazil. Polpharma will handle development and manufacturing, while Tuteur will manage commercialization, marketing and distribution across the licensed territories....
Merck Reports the P-III (TroFuse-005) Trial Data on Sacituzumab Tirumotecan for Advanced or Recurrent Endometrial Cancer
Merck disclosed Phase III TroFuse‑005 data for sacituzumab tirumotecan (sac‑TMT) in 776 patients with advanced or recurrent endometrial carcinoma or carcinosarcoma who had prior platinum‑based chemotherapy and PD‑1/PD‑L1 immunotherapy. The trial met its primary overall‑survival and progression‑free‑survival endpoints and also achieved...
Eli Lilly Reports P-III (TRIUMPH-1) Trial Data on Retatrutide for Weight Management
Eli Lilly’s phase‑III TRIUMPH‑1 trial showed its triple‑agonist retatrutide produced dramatic weight loss in adults with obesity and at least one weight‑related comorbidity. Across 80‑week endpoints, the 12 mg dose cut mean body weight by 28.3% and waist circumference by 24.1 cm, with...
Eli Lilly Acquires Engage Biologics for ~$202M
Eli Lilly announced the acquisition of Engage Biologics for roughly $202 million in cash, integrating Engage’s Tethosome non‑viral DNA delivery platform with Lilly’s growing genetic‑medicine portfolio. The deal includes an upfront payment and milestone‑based earn‑outs tied to development progress. Tethosome combines engineered DNA...
Sensome Reports the INSPECT Study Results of Its In Situ Tumor Detection Technology for Lung Cancer
Sensome disclosed first‑in‑human data from its INSPECT study, evaluating a microsensor‑enabled smart stylet for bronchoscopic lung biopsies in 27 patients across Australia and France. The device records tissue electrical signatures immediately before sampling, allowing real‑time differentiation of healthy, necrotic and...
Sunrise Group Wins the US FDA Clearance for Sunrise Air Home Sleep Apnea Test
Sunrise Group announced that its Sunrise Air at‑home sleep apnea test received U.S. FDA clearance, following a recent $29 million financing round. The lightweight, rechargeable device leverages mandibular jaw movement (MJM) technology combined with AI algorithms to produce clinician‑ready sleep reports....
UCB Reports P-III (BE BOLD) Trial Data on Bimzelx in Active Psoriatic Arthritis
UCB disclosed Phase III BE BOLD trial results comparing its Bimzelx (bimekizumab) to AbbVie’s Skyrizi (risankizumab) in 553 adults with active psoriatic arthritis. The primary endpoint was met, with 49.1% of patients achieving an ACR50 response at week 16 versus 38.4%...
EMA Marketing Authorization of New Drugs in April 2026
In April 2026 the European Medicines Agency granted marketing authorizations and CHMP positive opinions for a slate of new therapies spanning infectious disease, neurology, immunology, endocrinology and rare disorders. Merck’s Enflonsia monoclonal antibody reduced RSV‑related hospitalizations by 84% in infants,...
Vincentage Pharma Reports Topline P-III Trial Data on VCT220 for Weight Management
Vincentage Pharma announced topline results from its pivotal Phase III trial of VCT220, a GLP‑1 agonist, in 840 Chinese adults with obesity or overweight plus a comorbidity. Over 52 weeks, the 120 mg and 160 mg doses produced mean weight losses of 12.2%...
Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC
Bayer’s Hyrnuo (sevabertinib) received FDA priority review for first‑line treatment of adults with locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring HER2 kinase‑domain activating mutations and no prior systemic therapy. The review follows promising interim data from Cohort F...
Regeneron Inks a ~$2.3B Deal with Parabilis Medicines to Advance Antibody-Helicon Conjugates Across Multiple Therapeutic Areas
Regeneron has struck a strategic research collaboration with Parabilis Medicines to develop antibody‑Helicon conjugates (AHCs) across several therapeutic areas. The agreement provides Parabilis with $125 million, including $50 million upfront and a $75 million equity‑financing commitment, and makes it eligible for roughly $2.2 billion...
Sandoz Reports the EC Approval of Bysumlog and Dazparda (Biosimilars, Humalog and NovoRapid)
The European Commission has granted approval for Sandoz's biosimilar insulin pens Bysumlog (insulin lispro) and Dazparda (insulin aspart). Both products are authorized as prefilled pens for diabetes treatment in adults, children and patients as young as one year, demonstrating efficacy...
AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension
AstraZeneca’s Baxfendy (baxdrostat) received U.S. FDA approval for use with other antihypertensives in patients with uncontrolled or treatment‑resistant hypertension. The approval is based on the Phase III BaxHTN trial, which enrolled 796 participants and showed significant blood‑pressure reductions versus placebo. In...
Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment
Genentech’s Tecentriq and Tecentriq Hybreza received FDA approval as adjuvant therapies for adults with muscle‑invasive bladder cancer (MIBC) who show circulating tumor DNA (ctDNA) minimal residual disease after cystectomy. The approval is linked to Natera’s Signatera CDx assay, which was...
AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Approval in Early Breast Cancer for Two Indications
The U.S. FDA approved AstraZeneca and Daiichi Sankyo’s antibody‑drug conjugate Enhertu (trastuzumab deruxtecan) for two early‑stage HER2‑positive breast‑cancer indications. In the neoadjuvant setting, Enhertu combined with trastuzumab‑pertuzumab (THP) earned approval after the DESTINY‑Breast11 trial showed a 67.3% pathologic complete response...
Protara Therapeutics Reports P-II (ADVANCED-2) Trial on TARA-002 in BCG-Naïve Non-Muscle Invasive Bladder Cancer (NMIBC)
Protara Therapeutics presented 12‑month data from Cohort A of its Phase II ADVANCED‑2 trial evaluating TARA‑002 in patients with carcinoma in situ or CIS‑plus‑Ta/T1 non‑muscle‑invasive bladder cancer (NMIBC) who are BCG‑naïve. Of the 31 enrolled, 29 were efficacy‑evaluable, yielding an overall...
Resurge Therapeutics Presents Clinical Results on Its Intraprostatic Drug Elution (IPDE) Platform for Benign Prostatic Hyperplasia (BPH) at AUA 2026
Resurge Therapeutics presented data from two early‑phase studies of its intraprostatic drug elution (IPDE) platform for benign prostatic hyperplasia (BPH) at the AUA 2026 meeting. In the transperineal cohort of 20 patients, IPSS dropped 15 points and peak urinary flow...
Glooko Secures FDA Clearance for Cloud-Based EndoTool IV Insulin Dosing Platform
Glooko announced FDA 510(k) clearance for EndoTool IV Cloud, a cloud‑based insulin dosing platform for hospitalized patients receiving IV insulin. The solution uses the same algorithm as the existing EndoTool IV but moves dosing calculations to a secure cloud, reducing on‑premise infrastructure needs....
Biogen Reports P-II (CELIA) Trial Results on Diranersen in Early Alzheimer’s Disease
Biogen disclosed phase‑II (CELIA) results for intrathecal diranersen in 416 patients with early Alzheimer’s disease. The trial did not meet its primary dose‑response endpoint on CDR‑SB at week 76, but all dosing arms, especially 60 mg every‑four‑weeks, showed a slowing of clinical...
AstraZeneca’s Fasenra Receives the US FDA Approval for Hypereosinophilic Syndrome
The U.S. FDA has granted approval for AstraZeneca’s biologic Fasenra (benralizumab) to treat patients aged 12 and older with hypereosinophilic syndrome (HES) lacking a non‑hematologic secondary cause. Approval follows the Phase III NATRON trial, which enrolled 133 patients and compared 30 mg...
AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer
AstraZeneca presented Phase III VOLGA data showing that the combination of Imfinzi (durvalumab) and Enfortumab Vedotin improves event‑free survival and overall survival in muscle‑invasive bladder cancer patients who cannot receive cisplatin. The trial enrolled 695 patients undergoing radical cystectomy and compared two...
Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML
The U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) in combination with venetoclax for newly diagnosed acute myeloid leukemia patients who are 75 years or older or otherwise ineligible for intensive induction chemotherapy. The decision is based on...
BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma
BeOne Medicines received FDA accelerated approval for its BCL‑2 inhibitor Beqalzi (sonrotoclax) to treat adults with relapsed or refractory mantle‑cell lymphoma after at least two prior lines, including a BTK inhibitor. The decision was based on a global Phase I/II...
The US FDA New Drug Approvals in April 2026
In April 2026 the U.S. FDA approved two high‑impact drugs: Eli Lilly’s Foundayo (orforglipron) for weight loss in obese or overweight adults, and Merck’s Idvynso (doravirine + islatravir) as a switch option for virologically suppressed HIV‑1 patients. Foundayo demonstrated a 12.4% average weight...
Rigel Signs ~$445M Licensing Pact with Arvinas and Pfizer for Veppanu
Rigel has signed an exclusive, global licensing agreement with Arvinas and Pfizer to develop, manufacture and commercialize the FDA‑approved oral PROTAC drug Veppanu (vepdegestrant) for ER+/HER2‑, ESR1‑mutated advanced or metastatic breast cancer. The deal includes a $70 million upfront payment, a...
Tolion Health AI Launches AI-Powered Tolion Brain Coach App for Brain Health, Longevity, and Prevention of Alzheimer’s Disease
Tolion Health AI unveiled the Tolion Brain Coach, an AI‑driven mobile app that extends its Brain Health Platform with personalized, preventive insights for cognitive wellness. The app pulls data from Apple Health and Google Health Connect, analyzing more than 15...
Novo Nordisk Reports New STEP UP Trial Analyses on Wegovy 7.2mg for Weight Loss
Novo Nordisk presented new sub‑analyses from the STEP UP trial comparing its higher‑dose Wegovy 7.2 mg weekly injection with the approved 2.4 mg dose and placebo in over 1,400 obese adults without diabetes. Over 72 weeks, the 7.2 mg regimen produced an average 20.7%...
BMS Partners with Hengrui Pharma in a Potential ~$15.2B Deal to Advance 13 Early-Stage Programs Across Oncology, Hematology, and Immunology
Bristol‑Myers Squibb (BMS) has struck a strategic partnership with China’s Hengrui Pharma to advance 13 early‑stage programs covering oncology, hematology and immunology. Hengrui will lead early clinical development while BMS receives exclusive ex‑China rights to the assets, and Hengrui secures...
PulseSight Therapeutics Reports P-I (PST-611-CT1) Trial Data on PST-611 in Dry AMD/Geographic Atrophy
PulseSight Therapeutics presented Phase I (PST-611-CT1) trial data for PST-611 in dry age‑related macular degeneration (geographic atrophy) at ARVO 2026. The study enrolled six patients across two dose cohorts and demonstrated favorable safety, tolerability, stable best‑corrected visual acuity, and no...
Henlius Receives US FDA IND Clearance for HLX05-N (Biosimilar, Erbitux)
Henlius announced that the U.S. Food and Drug Administration granted Investigational New Drug (IND) clearance for HLX05‑N, its biosimilar version of Erbitux (cetuximab), aimed at treating metastatic colorectal cancer. The IND follows extensive analytical and non‑clinical studies that demonstrated high...
BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)
The European Commission has approved Bristol‑Myers‑Squibb’s oral drug Sotyktu (deucravacitinib) for adults with active psoriatic arthritis, either alone or with methotrexate. The decision follows positive Phase III data from the POETYK PsA‑1 and POETYK PsA‑2 trials, which enrolled over 1,200 patients and met...
CEAS Collective: Bridging Biotech Innovation and Consumer Wellness Through Direct-to-Patient Delivery
CEAS Collective is positioning itself at the intersection of biotech and consumer wellness by offering science‑driven products through a direct‑to‑patient delivery model. The company emphasizes rigorous quality control, sourcing botanicals with verified purity, and a digital logistics platform that bypasses...
The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors
The U.S. Food and Drug Administration has granted IND clearance for Harbour BioMed’s bispecific antibody HBM7004, allowing a Phase I trial in patients with advanced solid tumors. HBM7004 links the tumor‑associated antigen B7H4 to CD3, redirecting T‑cells to the tumor...
Bausch + Lomb Launches Bi-Blade+ Vitrectomy Cutter in the EU on Stellaris Elite Platform
Bausch + Lomb has introduced the Bi‑Blade+ dual‑port vitrectomy cutter on its Stellaris Elite Vision Enhancement System across the European Union. The new cutter delivers a 25% higher vitreous flow rate than the original Bi‑Blade, while cutting cutter vibration by 62%, which...
ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26
ALX Oncology reported exploratory Phase Ib/II data on evorpacept combined with Ziihera in 24 heavily pre‑treated HER2‑positive metastatic breast cancer patients, all of whom had previously received Enhertu. Overall, the regimen achieved a 33% confirmed overall response rate (cORR) with...
Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-Zova in X-Linked Retinitis Pigmentosa (XLRP)
Beacon Therapeutics presented 12‑month data from its Phase‑2 DAWN trial of laruparetigene zovaparvovec (laru‑zova) in patients with X‑linked retinitis pigmentosa (XLRP) who previously received an AAV‑RPGR gene therapy. The study showed sustained gains in low‑luminance visual acuity (LLVA) and microperimetry mean...
Bayer Reports P-III (REVEAL) Trial Data on Iodine 124 Evuzamitide to Diagnose Cardiac Amyloidosis
Bayer announced that its investigational PET/CT radiotracer I‑124 evuzamitide met the primary sensitivity and specificity endpoints in the Phase III REVEAL trial of 170 adults with suspected cardiac amyloidosis. The study compared the tracer to standard clinical diagnosis and achieved the...