Clinical Regulatory • Oct 5, 2026 • PR Newswire FDA
Abbott said the FDA has approved new capabilities for its CardioMEMS HF System, an implantable remote-monitoring sensor for heart failure patients designed to help them take a more active role in managing their condition.
Therapeutics Development • Oct 5, 2026 • BioSpace
Biogen reported new durability data for its lupus treatment in cutaneous (skin) disease, a result that strengthens the case for its sizable investment in the program.
Business & Strategy • Oct 5, 2026 • Fierce Pharma
BridgeBio is turning to YouTube and partnerships with hip-hop and public-health voices for a new campaign aimed at raising awareness of ATTR-CM, the rare heart condition treated by its drug Attruby.
Business & Strategy • Oct 5, 2026 • BioSpace
CSL has agreed to pay up to $1.6 billion to co-develop an Alentis Therapeutics drug for autoimmune disease, pairing the Australian company's commercial reach with a claudin-targeting candidate.
Clinical Regulatory • Oct 5, 2026 • FDA Newsroom
The FDA said it is seeking public input as part of an effort to support research into ibogaine, a psychedelic compound being studied for addiction and other psychiatric uses.
Business & Strategy • Oct 5, 2026 • BioSpace
Genentech has signed a deal worth up to $1.27 billion to license a preclinical blood-brain barrier asset from Alector, adding to its neurology pipeline.
Therapeutics Development • Oct 5, 2026 • Pharmaphorum
The 2026 Nobel Prize in Physiology or Medicine has been awarded to a trio of scientists for the discovery of optogenetics, a light-based method for switching neurons on and off that has become a foundational research tool in neuroscience.
Clinical Regulatory • Oct 5, 2026 • Fierce Pharma
Novo Nordisk said its U.S. review of a hemophilia candidate has been extended after the FDA flagged corrections needed at a manufacturing site, pushing back a potential approval decision.
Clinical Regulatory • Oct 5, 2026 • PR Newswire FDA
OMLYCLO (omalizumab-igec), described as the first and only FDA-approved interchangeable biosimilar to Xolair, is now commercially available in the United States.
Business & Strategy • Oct 5, 2026 • Pharmaphorum
Shionogi has agreed to acquire rare-disease specialist IntraBio for about $2 billion, extending the Japanese drugmaker's push beyond its core anti-infective business into neurology.
Therapeutics Development • Oct 2, 2026 • STAT News
Access to addiction meds for young people has improved — but retention hasn’t
Careers & Market • Oct 2, 2026 • Fierce Biotech
Adecto blames ‘risk-adverse funding environment’ for closing
Clinical Regulatory • Oct 2, 2026 • STAT News
An Ebola treatment center was burned down as the death toll in Congo passes 4,000
Business & Strategy • Oct 2, 2026 • Fierce Pharma
Bayer doubles down on US with $2.2B Ohio manufacturing project
Careers & Market • Oct 2, 2026 • Fierce Biotech
Bayer taps new chief medical officer—Chutes & Ladders
Business & Strategy • Oct 2, 2026 • BioSpace
BMO most bullish on Merck’s, bearish on BMS’ plans to contend with patent cliffs
Therapeutics Development • Oct 2, 2026 • Fierce Biotech
Buzzy AI biotech Xaira unveils antibody platform ambitions
Business & Strategy • Oct 2, 2026 • Pharmaphorum
Everlywell rolls out Clairity AI for breast cancer in US
Clinical Regulatory • Oct 2, 2026 • Fierce Pharma
Lilly’s BTK drug Jaypirca enters first-line CLL
Business & Strategy • Oct 2, 2026 • Fierce Pharma
Locking in on pharma’s consumerization trend
Therapeutics Development • Oct 2, 2026 • Pharmaphorum
New diabetes and obesity studies making waves at EASD
Business & Strategy • Oct 2, 2026 • STAT News
NIH rolling out streamlined website to help public find information more easily
Business & Strategy • Oct 2, 2026 • BioSpace
Sarepta could be ‘potential turnaround story’ with catalysts lined up into 2027
Business & Strategy • Oct 2, 2026 • Fierce Pharma
Teva, Samsung Bioepis deepen biosimilar bonds with new deal
Business & Strategy • Oct 2, 2026 • Pharmaphorum
UK puts £80m behind dementia diagnosis push
Clinical Regulatory • Oct 1, 2026 • Fierce Biotech
Analysts unshaken by patient death in BMS lung fibrosis trial
Business & Strategy • Oct 1, 2026 • Fierce Pharma
Asahi Kasei wraps years of global dealmaking into a single brand
Business & Strategy • Oct 1, 2026 • PR Newswire FDA
Avanos Medical, Inc. Launches Game Ready Over-the-Counter Recovery System in the U.S.
Business & Strategy • Oct 1, 2026 • Pharmaphorum
Bayer names Christoph Koenen as its new CMO
Therapeutics Development • Oct 1, 2026 • BioSpace
BMS reports liver injury events in lung disease program, with key readout near
Clinical Regulatory • Oct 1, 2026 • PR Newswire FDA
BTL Expands EXOMIND Platform with New FDA Clearances
Clinical Regulatory • Oct 1, 2026 • PR Newswire FDA
Clear Scientific Reports Positive Phase 2 Results for CS-1103, the First Investigational Therapeutic That Removes Fentanyl from the Body
Clinical Regulatory • Oct 1, 2026 • FDA Newsroom
FDA Approves First Heart Valve Designed to Grow with Children
Careers & Market • Oct 1, 2026 • BioSpace
Foghorn lays off 40% of staff after Lilly collaboration ends
Clinical Regulatory • Oct 1, 2026 • BioSpace
Fresenius Kabi manufacturing plant hit with FDA warning letter after adverse events
Business & Strategy • Oct 1, 2026 • Fierce Pharma
Genentech amplifies breast cancer conversations in new campaign
Therapeutics Development • Oct 1, 2026 • Fierce Biotech
Genentech's CEO on the next 50 years of the original biotech
Therapeutics Development • Oct 1, 2026 • Pharmaphorum
GLOBE model finalised, with narrowed scope and fewer savings
Therapeutics Development • Oct 1, 2026 • PR Newswire FDA
GORE ANNOUNCES FIRST PATIENT ENROLLMENT IN THE GORE EXCLUDER IBE PLUS STENT GRAFT PIVOTAL STUDY
Clinical Regulatory • Oct 1, 2026 • PR Newswire FDA
Imbed Biosciences' DualGuard Silver-Gallium Matrix Safety Study Now Registered on ClinicalTrials.gov
Therapeutics Development • Oct 1, 2026 • BioSpace
Kailera, Hengrui’s GLP-1/GIP candidate delivers weight, menstrual benefits to women with PMOS
Therapeutics Development • Oct 1, 2026 • Fierce Pharma
Lilly dives deep into Foundayo's cardio perks in T2D, obesity
Business & Strategy • Oct 1, 2026 • BioSpace
M&A slows in Q3 but Vertex snags one of the year's biggest in $10B Crinetics buy
Clinical Regulatory • Oct 1, 2026 • PR Newswire FDA
MavriX Bio Announces FDA Rare Pediatric Disease Designation for Investigational MVX-220 for the Treatment of Angelman Syndrome
Therapeutics Development • Oct 1, 2026 • BioSpace
Merck’s antibody impresses with ‘highly competitive’ data in chronic skin disease
Clinical Regulatory • Oct 1, 2026 • Pharmaphorum
NICE backs Sobi's Tryngolza for rare disease FCS
Business & Strategy • Oct 1, 2026 • BioSpace
Novartis bets up to $7.8B for an mRNA-encoded T cell engager from China’s Abogen
Clinical Regulatory • Oct 1, 2026 • PR Newswire FDA
PearlMatrix® P-15 Peptide Enhanced Bone Graft Receives Medicare New Technology Add-on Payment (NTAP), Helping Hospitals Accelerate Lumbar Fusion
Business & Strategy • Oct 1, 2026 • Fierce Pharma
Real Chemistry adds MaestroHCP to conduct omnichannel campaigns
Careers & Market • Oct 1, 2026 • Fierce Biotech
Recruiters see 'signs of recovery' as biotech layoffs stay cool
Therapeutics Development • Oct 1, 2026 • BioSpace
Sanofi pays Regeneron $1B upfront to continue search for Dupixent successor
Business & Strategy • Oct 1, 2026 • MedCity News
Sanofi Puts Up $1B to Expand Regeneron Alliance and Develop Next-Gen Dupixent
Clinical Regulatory • Oct 1, 2026 • Fierce Pharma
Taiho ph. 3 win sets up potential oral franchise expansion
Therapeutics Development • Oct 1, 2026 • STAT News
Top journal’s special issue on women’s health casts spotlight on menopause and pain
Clinical Regulatory • Oct 1, 2026 • BioSpace
US government launches AI-driven programs to overhaul clinical trials
Clinical Regulatory • Oct 1, 2026 • Fierce Biotech
Zealand slides as Boehringer-partnered obesity drug underwhelms
Careers & Market • Sep 30, 2026 • BioSpace
$40M in tax incentives expected to generate 1,600+ life sciences jobs in Massachusetts
Careers & Market • Sep 30, 2026 • Fierce Pharma
Alnylam drafts football veteran for heart disease education push
Clinical Regulatory • Sep 30, 2026 • Fierce Biotech
Amgen reveals 6-point drop in lupus severity behind ph. 2 win
Clinical Regulatory • Sep 30, 2026 • Pharmaphorum
Apogee buy delivers eczema trial win for AbbVie
Clinical Regulatory • Sep 30, 2026 • BioSpace
Atara, Pierre Fabre resubmit twice-rebuffed cell therapy after FDA flips again
Therapeutics Development • Sep 30, 2026 • Fierce Biotech
Beam sues rival startup, claims former scientist stole secrets
Careers & Market • Sep 30, 2026 • Fierce Pharma
BioMarin lays off 117 California workers to consolidate footprint
Clinical Regulatory • Sep 30, 2026 • Fierce Biotech
Connect drug reduces COPD attacks 85%, misses a secondary goal
Clinical Regulatory • Sep 30, 2026 • PR Newswire FDA
FDA ACCEPTS NEW DRUG APPLICATION FOR CELECOR'S INVESTIGATIONAL HEART-ATTACK DRUG
Clinical Regulatory • Sep 30, 2026 • FDA Newsroom
FDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees
Clinical Regulatory • Sep 30, 2026 • PR Newswire FDA
FIRE1 Announces First Patient Implant in the NORM-HF Pivotal Trial Evaluating a New Physiologic Approach to Heart Failure Management
Therapeutics Development • Sep 30, 2026 • PR Newswire FDA
Gluware Extends Its Automation Platform Beyond the Network to Connected Medical Devices
Business & Strategy • Sep 30, 2026 • Fierce Biotech
GSK continues stockpiling Wave drugs with liver-focused program
Clinical Regulatory • Sep 30, 2026 • Fierce Biotech
Highlight Therapeutics illuminates positive data in skin cancer
Business & Strategy • Sep 30, 2026 • BioSpace
Lilly builds commercial case for GLP-1 products over Novo with indirect analyses
Business & Strategy • Sep 30, 2026 • Fierce Biotech
Lilly raises diabetes weight-loss bar with amylin-Zepbound combo
Therapeutics Development • Sep 30, 2026 • PR Newswire FDA
Lilly reported that its investigational EloraTZP combination of eloralintide and tirzepatide delivered greater weight loss and A1c reduction than tirzepatide 15 mg alone in adults with obesity and type 2 diabetes.
Clinical Regulatory • Sep 30, 2026 • Fierce Biotech
Lilly sets up next-gen obesity war with phase 3 retatrutide data
Clinical Regulatory • Sep 30, 2026 • PR Newswire FDA
Medtronic announces regulatory milestones for newest cardiac mapping and ablation software
Clinical Regulatory • Sep 30, 2026 • Fierce Biotech
Merck's anti-TL1A secures a ph. 2 hidradenitis suppurativa win
Clinical Regulatory • Sep 30, 2026 • PR Newswire FDA
Newronika Announces First Participant Implanted in ADVENT Pivotal Study
Careers & Market • Sep 30, 2026 • Fierce Pharma
Novo is handing out pink slips to 108 staffers in New Jersey
Business & Strategy • Sep 30, 2026 • Fierce Pharma
Organon phones home with sci-fi themed Vtama campaign
Business & Strategy • Sep 30, 2026 • Pharmaphorum
PhRMA hires ex-House Majority Leader Eric Cantor as its CEO
Clinical Regulatory • Sep 30, 2026 • PR Newswire FDA
Pierre Fabre Pharmaceuticals Resubmits Tabelecleucel Biologics License Application for Treatment of Epstein-Barr Virus Positive-Post-Transplant Lymphoproliferative Disease to the FDA
Business & Strategy • Sep 30, 2026 • Fierce Pharma
Radiopharmaceutical player NorthStar locks up $185M
Clinical Regulatory • Sep 30, 2026 • Fierce Biotech
Roche, Zealand see phase 2 amylin weight loss peak at mid-dose
Clinical Regulatory • Sep 30, 2026 • BioSpace
Superior weight loss, blood sugar control propel Lilly's amylin-GIP/GLP-1 combo into Phase 3
Business & Strategy • Sep 30, 2026 • BioSpace
Trend of women-led M&A fades in 2026 with just two deals so far
Business & Strategy • Sep 30, 2026 • Pharmaphorum
Two men charged with infiltrating fake Ozempic into US
Business & Strategy • Sep 30, 2026 • PR Newswire FDA
UPSHER-SMITH LAUNCHES FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES
Business & Strategy • Sep 30, 2026 • Fierce Pharma
Varda series D brings $251M for space-based drug production
Therapeutics Development • Sep 30, 2026 • PR Newswire FDA
VEMERIX Launches Patented Single-Use Ultrasound Guidance Puncture Kit With Probe-Matched Customization
Clinical Regulatory • Sep 29, 2026 • BioSpace
AbbVie wins FDA approval for Parkinson's drug from $8.7B Cerevel takeover
Clinical Regulatory • Sep 29, 2026 • PR Newswire FDA
Acurx Pharmaceuticals Announces First Patient Enrolled in PATHFINDER Clinical Trial of Ibezapolstat in Multiply-Recurrent C. difficile Infection
Therapeutics Development • Sep 29, 2026 • Fierce Biotech
ai3Bio buzzing with $48M for STING pathway targeting pipeline
Therapeutics Development • Sep 29, 2026 • Fierce Pharma
Audien beams up William Shatner to boldly boost hearing aid biz
Therapeutics Development • Sep 29, 2026 • Reuters Biopharma
Australia's CSL taps Amazon's cloud unit to boost research pipeline
Therapeutics Development • Sep 29, 2026 • PR Newswire FDA
BiomEdit's First-of-its-Kind Engineered Bacterial Biologic for Poultry Receives Conditional Licensure from USDA
Clinical Regulatory • Sep 29, 2026 • Fierce Biotech
Canadian $5M clinical trial program cuts start-up to 45 days
Clinical Regulatory • Sep 29, 2026 • PR Newswire FDA
Cepheid Receives FDA Clearance for Xpert® Respiratory Panel to Aid in the Diagnosis of Respiratory Tract Infection
Business & Strategy • Sep 29, 2026 • PR Newswire FDA
Cytrellis Announces Partnership for Commercialization of ellacor® Micro-Coring® Technology in South Korea
Clinical Regulatory • Sep 29, 2026 • PR Newswire FDA
Decoy Therapeutics Reports Preclinical Data Supporting Once-Weekly Intranasal Dosing for DCOY-CoV Program
Therapeutics Development • Sep 29, 2026 • PR Newswire FDA
FastWave Medical Reports 96.4% Procedural Success in First-in-Human Study of Sola™ Coronary Laser IVL System
Business & Strategy • Sep 29, 2026 • FDA Newsroom
FDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
Therapeutics Development • Sep 29, 2026 • PR Newswire FDA
Implantica's RefluxStop® U.S. market launch kicked off at the 2026 American Foregut Society Meeting, receiving an outstanding reception
Careers & Market • Sep 29, 2026 • Fierce Pharma
Inizio Evoke names new leaders in media, AI and client accounts
Business & Strategy • Sep 29, 2026 • Pharmaphorum
Lilly forges $3.35bn alliance with China's InnoCare
Clinical Regulatory • Sep 29, 2026 • BioSpace
Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADC
Therapeutics Development • Sep 29, 2026 • Pharmaphorum
Mirum puts Hepcludex in its sights with hep D readout
Business & Strategy • Sep 29, 2026 • BioSpace
Novo adds long-term obesity differentiation in up to $2.6B Hengrui deal
Clinical Regulatory • Sep 29, 2026 • Fierce Pharma
Novo, Lilly unleash dueling GLP-1 datasets at EASD in Milan
Therapeutics Development • Sep 29, 2026 • PR Newswire FDA
Packaging Compliance Labs Enters Pharmaceutical Testing Market with Dedicated Lab and Expert Leadership
Therapeutics Development • Sep 29, 2026 • Reuters Biopharma
Pfizer, Moderna lose bids to escape Bayer US mRNA patent lawsuit
Therapeutics Development • Sep 29, 2026 • Fierce Pharma
PhRMA locks in former House Majority Leader Cantor as next CEO
Clinical Regulatory • Sep 29, 2026 • PR Newswire FDA
Public Comment Sought on Draft FDA Petition to Require a Warning Label on Raw Milk Cheese - All Comments Due by October 9
Clinical Regulatory • Sep 29, 2026 • PR Newswire FDA
Publication of ROADS Phase 3 Clinical Trial Data in Journal of Clinical Oncology Recommends GammaTile® as a New Standard-of-Care Option for Newly Diagnosed Operable Brain Metastases1
Therapeutics Development • Sep 29, 2026 • BioSpace
Roche cuts muscle-sparing obesity drug after mid-stage disappointment
Business & Strategy • Sep 29, 2026 • BioSpace
Summit snags $2B investment from AstraZeneca, clearing financial overhang
Business & Strategy • Sep 29, 2026 • Pharmaphorum
Telix to buy radiopharma rival ITM for $1.65bn upfront
Therapeutics Development • Sep 29, 2026 • Pharmaphorum
uniQure falls on long-term Huntington's gene therapy data
Business & Strategy • Sep 29, 2026 • Fierce Pharma
US details rules for pharmaceutical tariff exemptions
Clinical Regulatory • Sep 29, 2026 • PR Newswire FDA
UTR Therapeutics Inc. Announces U.S. FDA Orphan Drug Designation and Rare Pediatric Disease Designation for UTRxMYCN M1-14
Clinical Regulatory • Sep 29, 2026 • PR Newswire FDA
VertigoDx Secures FDA 510(k) Clearance for SmartVertigo® Point-of-Care Vestibular Diagnostic System
Business & Strategy • Sep 29, 2026 • Fierce Pharma
White House looks to ramp up domestic generic manufacturing
Clinical Regulatory • Sep 29, 2026 • PR Newswire FDA
XYone Therapeutics Announces First Patient Dosed in First-in-Human Clinical Trial of XYA02(AT2021), a Novel Antibody Drug Conjugate targeting MUC1-C
Therapeutics Development • Sep 28, 2026 • BioSpace
6 immunology targets to sustain a mammoth I&I market
Therapeutics Development • Sep 28, 2026 • Fierce Biotech
As the race to harness CAR-T cells for autoimmune diseases hits a rough patch, Adicet Bio is reporting an early sign of efficacy in lupus, with remissions in an early-stage trial.
Therapeutics Development • Sep 28, 2026 • STAT News
AI is eroding the barriers that kept biological weapons rare
Therapeutics Development • Sep 28, 2026 • Fierce Pharma
BioNTech to close sites in Germany after failed sale
Clinical Regulatory • Sep 28, 2026 • PR Newswire FDA
BRC Therapeutics Joins FDA and EMA Regulators at Workshop Advancing the Future of Botanical Drug Development
Clinical Regulatory • Sep 28, 2026 • FDA Newsroom
FDA Approves First Treatment for MCT8 Deficiency
Clinical Regulatory • Sep 28, 2026 • FDA Newsroom
FDA intends to evaluate changes to the PMTA regulatory framework
Clinical Regulatory • Sep 28, 2026 • BioSpace
FDA nod for Mirum's Atebrioz makes 3 options for ultra-rare bone disease
Therapeutics Development • Sep 28, 2026 • PR Newswire FDA
Fuse Oncology and Associated Medical Professionals of NY Launch Proof of Concept for End-to-End Radiation Oncology Workflow in Urology
Clinical Regulatory • Sep 28, 2026 • PR Newswire FDA
Insera Therapeutics, Inc. Receives U.S. FDA 510(k) Clearance for the CLEAR™ Aspiration System Featuring Cyclical Aspiration
Careers & Market • Sep 28, 2026 • BioSpace
Kodiak Sciences’ stock soars 166% after 2 assets match Eylea in Phase 3 trial
Therapeutics Development • Sep 28, 2026 • Fierce Biotech
Kodiak Sciences' stock doubled after the biotech reported a pivotal-trial win for an eye disease drug candidate it had previously set aside, reviving the programme's path toward a regulatory filing.
Business & Strategy • Sep 28, 2026 • Fierce Pharma
Eli Lilly's weight loss and diabetes medicines have become a dominant force in the market, but access varies widely around the world. A new initiative aims to take GLP-1s to lower-income nations by 2040.
Clinical Regulatory • Sep 28, 2026 • PR Newswire FDA
Lupin has received tentative approval from the U.S. FDA for Apixaban Oral Suspension 1.25 mg/mL, an oral liquid formulation of the active ingredient in Eliquis that offers an alternative administration option for adults requiring anticoagulation therapy.
Business & Strategy • Sep 28, 2026 • BioSpace
Merck continues to diversify its cancer efforts as the clock ticks down on Keytruda's patent, picking up rights to a preclinical oncology asset in a deal that could exceed $2 billion.
Clinical Regulatory • Sep 28, 2026 • BioSpace
Milestone Sanfilippo nod helps Ultragenyx regroup after tough Angelman defeat
Therapeutics Development • Sep 28, 2026 • Fierce Biotech
A phase 3 trial of Mirum Pharmaceuticals' chronic hepatitis delta virus drug candidate has hit its primary endpoint, furthering the biotech's efforts to enter a space recently colonized by Gilead Sciences.
Clinical Regulatory • Sep 28, 2026 • Pharmaphorum
MSD and Daiichi Sankyo's regulatory efforts for their ADCs for cancer have stuttered again, with a withdrawn filing for lung cancer candidate I-DXd.
Therapeutics Development • Sep 28, 2026 • STAT News
Risk from toxic metals can persist months after wildfires, Maui study finds
Therapeutics Development • Sep 28, 2026 • Pharmaphorum
Roche has abandoned the development of one of its obesity candidates, emugrobart, and returned rights to originator Chugai Pharma.
Clinical Regulatory • Sep 28, 2026 • Fierce Pharma
Roche's Gazyva secures FDA nod in 2nd autoimmune indication
Business & Strategy • Sep 28, 2026 • Fierce Biotech
BARDA has awarded Scynexis a contract worth up to $214 million for development of a treatment for invasive fungal infections. The non-dilutive funding includes nearly $18.5 million up front to push antifungal candidate SCY-247 into phase 2, with options to extend the contract for up to ten years.
Therapeutics Development • Sep 28, 2026 • Pharmaphorum
A new study suggests long-read 'nanopore' sequencing could transform the diagnosis of inherited diseases and unlock new insights for drug discovery.
Business & Strategy • Sep 28, 2026 • Fierce Biotech
After vaulting into the clinic by licensing a fusion protein last month, Tolerance Bio has continued to strengthen its thymus-focused pipeline by picking up an anti-IL-33 drug from Tanabe Pharma.
Clinical Regulatory • Sep 28, 2026 • PR Newswire FDA
Fondazione Telethon and UCSF Benioff Children's Hospitals say the hospital is the first U.S. qualified treatment center contracted to administer the individualized gene therapy WASKYRA.
Therapeutics Development • Sep 28, 2026 • PR Newswire FDA
UCSF Benioff Children's Hospitals Become the First US Qualified Treatment Center Contracted to Administer Individualized Gene Therapy WASKYRA®
Business & Strategy • Sep 28, 2026 • Reuters Biopharma
US drugmakers turn to China for licensing deals
Clinical Regulatory • Sep 28, 2026 • PR Newswire FDA
AbbVie's JUVMO (tavapadon) is the first and only selective D1/D5 receptor agonist approved for adults with Parkinson's disease. The once-daily tablet works with or without levodopa, and the approval is supported by the Phase 3 TEMPO programme.