Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection
Merck’s Idvynso, a once‑daily tablet combining 100 mg doravirine with 0.25 mg islatravir, received FDA approval as a switch regimen for virologically suppressed HIV‑1 adults. The approval rests on two Phase III trials—Trial 052 (n=513) and Trial 051 (n=551)—which demonstrated comparable viral suppression to existing therapies. In both studies, only about 1% of participants on Idvynso experienced HIV‑1 RNA ≥ 50 copies/mL at week 48, matching or outperforming the control arms. The drug targets patients on stable regimens without prior treatment failure or doravirine resistance.
Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)
Biocon has secured a Notice of Compliance from Health Canada for its denosumab biosimilars, Bosaya and Vevzuo, which mirror Amgen’s Prolia and Xgeva. The approval follows a comprehensive data package demonstrating comparable quality, safety and efficacy to the reference products....
Monopar Therapeutics Reports P-III (FoCus) Trial Data on ALXN1840 in Wilson Disease
Monopar Therapeutics reported Phase III FoCus trial results for ALXN1840, an oral copper‑binding agent, in Wilson disease patients with neurologic involvement. The study enrolled 77 patients on ALXN1840 and 35 on standard of care, showing neurologic worsening in only 9% versus...
Akeso Announces P-II (COMPASSION-26) Trial Results on Cadonilimab + CT in 1L PDAC
Akeso reported Phase II COMPASSION‑26 data showing its bispecific antibody cadonilimab combined with chemotherapy as a first‑line option for advanced pancreatic ductal adenocarcinoma. With a median progression‑free survival of 11.1 months and median overall survival exceeding 23 months, the regimen delivered 12‑month and...
Eli Lilly to Acquire Kelonia Therapeutics for ~$7B
Eli Lilly announced a definitive agreement to acquire Kelonia Therapeutics for roughly $7 billion in cash, including an upfront payment of $3.25 billion. The deal brings Kelonia’s in‑vivo gene placement system (iGPS0) and its lead candidate, KLN‑1010, a one‑time IV gene therapy that...
Pheast Therapeutics Reports Early P-Ia Data for PHST001 at AACR 2026
Pheast Therapeutics presented initial Phase Ia data for its anti‑CD24 macrophage checkpoint inhibitor PHST001 at the AACR 2026 meeting. The study showed clear target engagement, activation of innate immunity and a favorable safety profile across dose‑escalation cohorts. Early clinical signals...
Novo Nordisk Reports Positive P-III (HIBISCUS) Study Data for Etavopivat in Sickle Cell Disease
Novo Nordisk announced that its oral pyruvate kinase activator etavopivat met both primary endpoints in the Phase III HIBISCUS trial for sickle cell disease. In 385 patients aged 12 and older, the drug reduced vaso‑occlusive crisis (VOC) rates by 27% and...
AstraZeneca Reports Positive P-III (MIRANDA) Data for Tozorakimab in COPD
AstraZeneca announced that its anti‑IL‑33 antibody tozorakimab achieved its primary endpoint in the Phase III MIRANDA trial, delivering a statistically significant reduction in the annualised rate of moderate‑to‑severe COPD exacerbations. The double‑blind study enrolled 1,454 patients receiving standard inhaled therapy and...
Innate Pharma to Present P-II (MATISSE) Interim Data of IPH5201 in NSCLC at AACR 2026
Innate Pharma will present interim Phase‑II (MATISSE) data for its anti‑CD39 antibody IPH5201 in resectable non‑small cell lung cancer (NSCLC) at the AACR 2026 meeting. The analysis of 40 patients shows a pathological complete response (pCR) of 35.7% in tumors...
Pulnovo Raises $100M Led by Medtronic to Advance PADN System for Pulmonary Hypertension
Pulnovo Medical announced an oversubscribed $100 million financing round led by Medtronic, bringing together existing backers such as EQT, Qiming Venture Partners, Gaorong Ventures, OrbiMed and Lilly Asia Ventures. The capital will accelerate clinical development, regulatory work and commercialization of Pulnovo’s...
EpiBiologics Reports First Patient Dosed in P-I Study of EPI-326 for EGFR-Driven Solid Tumors
EpiBiologics has dosed the first patient in a global Phase‑1 trial of EPI‑326, a tissue‑selective bispecific antibody that targets EGFR in advanced solid tumors. The study will assess safety, tolerability, pharmacokinetics and early anti‑tumor activity in non‑small cell lung cancer...
LEO Pharma’s Enstilar Receives the NMPA Approval for Plaque Psoriasis
LEO Pharma’s topical aerosol foam Enstilar, combining calcipotriene and betamethasone dipropionate, received approval from China’s National Medical Products Administration for adult plaque psoriasis. The approval follows a Phase III trial of 604 Chinese patients that demonstrated superior efficacy and safety versus...
Piramal Pharma Solutions Partners with Ajinomoto Bio-Pharma Services to Advance ADC Development and Manufacturing
Piramal Pharma Solutions and Ajinomoto Bio‑Pharma Services have signed a strategic collaboration to accelerate antibody‑drug conjugate (ADC) development and manufacturing. Piramal will refer its customers to Ajinomoto’s AJICAP platform for site‑specific ADC conjugation, while Ajinomoto will direct clients to Piramal...
Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya
Swissmedic has granted approval to Bavarian Nordic’s Vimkunya, a single‑dose, virus‑like particle vaccine for chikungunya, targeting individuals 12 years and older. The vaccine is designed to elicit protective immunity as early as one week after injection. Bavarian Nordic has also...
Radiopharm Completes Final Patient Dosing of RAD 101 for Diagnosis of Brain Metastases in the US
Radiopharm Theranostics announced the final patient dosing in its U.S. Phase IIb trial of the 18F‑RAD101 PET imaging agent for recurrent brain metastases. The study enrolled 30 patients and interim results demonstrated 90% concordance with MRI, meeting the predefined efficacy...
Philips Receives US FDA 510(k) Clearance for AI-Powered Spectral CT Verida System
Philips has obtained FDA 510(k) clearance for its Verida spectral CT system, the world’s first AI‑powered detector‑based spectral CT platform. The system combines always‑on spectral imaging with deep‑learning reconstruction, delivering higher image quality, lower noise, and enhanced tissue characterization. It...
Aligos Therapeutics Licenses Pevifoscorvir Sodium to Xiamen Amoytop Biotech for Greater China
Aligos Therapeutics signed an exclusive license with Xiamen Amoytop Biotech to develop and commercialize its hepatitis B candidate pevifoscorvir sodium in Greater China. The agreement provides Aligos with a $25 million upfront payment and up to $420 million in milestone fees, plus...
Interna Therapeutics Collaborates with Daiichi Sankyo to Develop MNM-Based Targeted Delivery Technologies
Interna Therapeutics announced a research collaboration with Daiichi Sankyo’s Boston Research Institute to evaluate its MNM (Molecular Nanoparticle Matrix) technology as a delivery enhancer for targeted therapeutics. The partnership will integrate MNM molecules with Daiichi Sankyo’s targeting approaches, beginning with...
LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema
LEO Pharma announced that the U.S. Food and Drug Administration has accepted a supplemental New Drug Application for Anzupgo (delgocitinib) cream targeting adolescents aged 12 to 17 with moderate‑to‑severe chronic hand eczema. The acceptance follows the Phase III DELTA TEEN trial, which...
CareDx to Divest Lab Products Unit to EuroBio Scientific for $170M
CareDx announced a definitive agreement to sell its Lab Products business, which includes PCR and next‑generation sequencing transplant diagnostics, to EuroBio Scientific for $170 million in cash. The divestiture allows CareDx to streamline operations and concentrate on its core Precision Medicine...
AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia
The U.S. Food and Drug Administration has granted approval for Rapiblyk (landiolol) for pediatric patients from birth through 17 years old suffering from supraventricular tachycardia (SVT). The decision follows the LANDI‑PED trial, which enrolled 60 children and demonstrated a greater...
ARS Pharmaceuticals Reports Health Canada Approval of Neffy 2mg to Treat Type I Allergic Reactions
Health Canada has approved ARS Pharma’s neffy 2 mg adrenaline nasal spray for adults and children weighing over 30 kg, marking the first needle‑free emergency treatment for anaphylaxis in the country. In November 2024, ARS granted ALK exclusive rights to commercialize neffy...
TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test
TOBY has received FDA Breakthrough Device Designation for its urine‑based Multi‑Cancer Early Detection (MCED) test. The non‑invasive platform analyzes volatile organic compounds in a single urine sample using spectroscopy and machine‑learning algorithms to identify multiple cancer types. The designation positions...
QIAGEN Launches QIAstat-Dx BCID GPF Plus AMR Panel for Bloodstream Infection Syndromic Testing
QIAGEN has launched the CE‑IVDR‑certified QIAstat‑Dx BCID GPF Plus AMR Panel for rapid bloodstream‑infection syndromic testing. The assay detects 20 gram‑positive bacterial and fungal targets and ten antimicrobial‑resistance markers, delivering results in approximately one hour. Announced at the ESCMID Global...
Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma
Partner Therapeutics has filed a supplemental Biologics License Application (sBLA) with the U.S. FDA for Bizengri (zenocutuzumab‑zbco), a monoclonal antibody designed for adults with advanced unresectable or metastatic cholangiocarcinoma that carry an NRG1 gene fusion. The filing is supported by...
The US FDA New Drug Approvals in March 2026
In March 2026 the U.S. FDA approved five new therapies spanning hepatology, dermatology, rare genetics, oncology, and endocrinology. GSK’s Lynavoy treats cholestatic pruritus in primary biliary cholangitis, while Johnson & Johnson’s Icotyde targets moderate‑to‑severe plaque psoriasis. Denali Therapeutics earned accelerated...
American Industrial Partners to Acquire Avanos Medical for ~$1.272B
American Industrial Partners (AIP) has agreed to acquire Avanos Medical in an all‑cash deal valued at approximately $1.272 billion. Avanos shareholders will receive $25 per share, a 72.1% premium to the April 13 closing price. The transaction will take Avanos private and...
SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
SynOx Therapeutics announced topline data from its global Phase 3 TANGENT trial, which evaluated emactuzumab (1,000 mg every two weeks for five doses) versus placebo in patients with tenosynovial giant cell tumor (TGCT). The study met both primary efficacy endpoints, showing a...
Protaryx Medical Secures FDA Clearance for Its Transseptal Access Device
Protaryx Medical announced that the U.S. Food and Drug Administration granted 510(k) clearance for its Transseptal Puncture Device, a next‑generation system designed for minimally invasive left‑heart access. The device uses radio‑frequency guidewire technology integrated with standard electrosurgical generators and features...
Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS
Travere Therapeutics announced that the U.S. Food and Drug Administration has granted full approval to Filspari (sparsentan) for reducing proteinuria in patients aged eight years and older with focal segmental glomerulosclerosis (FSGS) who do not have nephrotic syndrome. The approval...
Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC
Daiichi Sankyo and Merck have secured FDA priority review for ifinatamab deruxtecan (I‑DXd) under the Real‑Time Oncology Review and Project Orbis programs. The decision follows a successful Biologics License Application based on the Phase II IDeate‑Lung01 trial, which enrolled 187 extensive‑stage...
Eli Lilly Reports P-III (BRUIN CLL-322) Trial Data on Jaypirca Combination for CLL/SLL
Eli Lilly announced that its phase‑III BRUIN CLL‑322 trial showed the Jaypirca (pirtobrutinib) + venetoclax + rituximab regimen significantly extended progression‑free survival in relapsed or refractory CLL/SLL compared with venetoclax + rituximab alone. Patients were treated for roughly two years before entering a therapy‑free interval, and the benefit...
Haisco Partners with AbbVie to Develop Novel Medicines for Pain in a ~$745M Deal
Haisco Pharma signed an exclusive licensing agreement with AbbVie to develop, manufacture and commercialize novel pain medicines outside China, Hong Kong and Macau. The deal provides Haisco with a $30 million upfront payment and up to $715 million in development, regulatory and...
Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)
Regeneron and Sanofi announced that the European Commission has approved Dupixent (dupilumab) for moderate‑to‑severe chronic spontaneous urticaria in children aged 2‑11 who remain symptomatic despite antihistamines. The decision follows two Phase‑III studies—LIBERTY‑CUPID and CUPIDKids—that demonstrated significant reductions in UAS7 scores...
Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems
Miracell announced that the U.S. Food and Drug Administration granted 510(k) clearance for its SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including the related kits. The clearance was based on substantial equivalence to the previously cleared SmartPReP...
Oxford BioTherapeutics Partners with BMS to Develop Next-Generation T-Cell Engagers for Solid Tumors
Oxford BioTherapeutics (OBT) announced a multi‑year strategic collaboration with Bristol Myers Squibb (BMS) to discover and develop next‑generation T‑cell engager therapies for solid tumors. OBT will apply its OGAP‑Verify platform to identify tumor‑selective antigens and design candidate molecules, while BMS...
DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer
DualityBio announced that China’s National Medical Products Administration has accepted its Biologics License Application for trastuzumab pamirtecan (T‑Pam), an investigational antibody‑drug conjugate targeting HER2‑positive metastatic breast cancer. The submission is backed by interim data from the pivotal Phase III DB‑1303‑O‑3001 trial,...
Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN
Health Canada has granted approval for Empaveli (pegcetacoplan) to treat patients aged 12 and older with C3 glomerulopathy (C3G) or primary immune‑complex membranoproliferative glomerulonephritis (IC‑MPGN). The decision follows the Phase III VALIANT trial, which demonstrated a 68% reduction in proteinuria, stabilization...
Telix Reports US FDA Acceptance of NDA for TLX101-Px (Pixclara) in Glioma Imaging
Telix Pharma announced that the U.S. FDA has accepted the resubmitted New Drug Application for TLX101‑Px, marketed as Pixclara, an investigational 18F‑FET PET imaging agent for glioma detection in adults and children. The agency set a PDUFA action date of...
Kymera Therapeutics Reports Gilead’s Option Exercise to License KT-200, a CDK2 Molecular Glue Degrader
Gilead Sciences exercised its option to exclusively license KT‑200, a first‑in‑class oral CDK2 molecular‑glue degrader, from Kymera Therapeutics. The transaction triggers a $45 million milestone payment, with Kymera eligible for up to $750 million in additional milestones and tiered royalties. Gilead will...
Imagene AI Partners with Daiichi Sankyo to Advance Multimodal Biomarker Discovery in Oncology
Imagene AI has teamed up with Daiichi Sankyo to use its OI Suite, powered by the CanvOI foundation model, for multimodal biomarker discovery in oncology. The collaboration will integrate H&E and IHC whole‑slide images with molecular and clinical data to...
DeepCyte Secures $1.5M to Advance AI-Driven Single-Cell Toxicology in Drug Development
DeepCyte, a tech‑bio startup, announced a $1.5 million seed round to launch its AI‑driven toxicology suite for drug development. The company introduced MetaCore, a high‑throughput single‑cell metabolomics platform that uses laser‑based sampling and mass spectrometry to generate AI‑ready data. Its first...
PharmaShots Magazine-April-2026 Edition
The April 2026 edition of PharmaShots spotlights AI’s rapid infiltration into pharmaceutical compliance, turning regulatory oversight into a continuous, data‑driven process. It also details a wave of high‑value deals, with Biogen, Eli Lilly and Merck acquiring AI‑centric assets and forging partnerships...
C4 Therapeutics and Roche Enter Oncology Collaboration Worth Over $1B to Develop DAC with Payload
C4 Therapeutics and Roche have signed a multi‑billion‑dollar partnership to develop degrader‑antibody conjugates (DACs) for cancer treatment. The deal launches two undisclosed oncology programs, with C4 providing its Torpedo degrader payload platform and Roche handling antibody selection, conjugation, and downstream...
Waters Expands Cervical Cancer Screening Access with At-Home HPV Test Approval
The U.S. FDA has cleared the Onclarity HPV Self‑Collection Kit and approved the BD Onclarity HPV Assay for at‑home cervical cancer screening. The kit detects every high‑risk HPV genotype, delivering both individual and pooled results, and is processed on the...
Vanda Pharmaceuticals Initiates Thetis Study of Nereus for GLP-1–Induced Vomiting Prevention
Vanda Pharmaceuticals has launched the Phase‑III Thetis trial to test Nereus (tradipitant) against placebo for preventing vomiting in patients on GLP‑1 receptor agonists. The study’s primary endpoint is the proportion of participants who remain vomiting‑free, with topline data slated for...
Astellas Exercises Option to License Dyno’s AAV Capsid for AI-Designed Gene Delivery
Astellas has exercised its option to license an AI‑engineered adeno‑associated virus (AAV) capsid from Dyno Therapeutics for skeletal muscle gene delivery, marking the first licensed asset from their 2021 partnership. The capsid, created using Dyno’s large‑scale in‑vivo data‑driven AI models,...
Garda to Acquire Assertio for ~$125.1M Upfront
Garda Therapeutics has signed a definitive agreement to acquire Assertio for $18 per share in cash, roughly $125.1 million, plus a non‑tradeable contingent value right linked to future Sprix milestones. The transaction also incorporates a $35 million upfront payment from the sale...
Anumana Secures the US FDA 510(k) Clearance for Its ECG-AI Algorithm to Detect Risk of Cardiac Amyloidosis Early
Anumana has received FDA 510(k) clearance for its ECG‑AI algorithm, a software‑as‑a‑medical‑device that screens for cardiac amyloidosis using routine 12‑lead electrocardiograms. The AI model, originally developed at the Mayo Clinic, identifies subtle waveform patterns invisible to clinicians, enabling early risk...
Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC
Nuvalent has submitted a New Drug Application to the U.S. FDA for neladalkib, an ALK‑selective inhibitor intended for patients with advanced ALK‑positive non‑small cell lung cancer (NSCLC) who have progressed after prior tyrosine‑kinase inhibitor (TKI) therapy. The filing is backed...