Gibson Oncology has launched a Phase 2 trial of its dual‑action drug LMP744 in patients with first‑time recurrent glioblastoma. The compound simultaneously inhibits topoisomerase 1 and down‑regulates the cMYC oncogene, aiming to disrupt tumor proliferation. The study will enroll about 40 patients, with tumor regression as the primary endpoint and survival metrics as secondary measures. Earlier Phase 1 work showed a favorable safety profile and tumor shrinkage in a subset of heavily pretreated cancer patients.
Researchers evaluated crude extracts from the African weed Tithonia diversifolia and the nightshade Solanum torvum for antibacterial activity against several Shigella strains. In vitro assays demonstrated clear zones of inhibition, with minimum inhibitory concentrations between 125 µg/mL and 250 µg/mL. Both extracts...
The study introduces BG/SOD@ZIF‑zc, a multifunctional nanoplatform that encapsulates superoxide dismutase within a copper‑doped ZIF framework and coats it with bacterial ghosts for targeted delivery to the colon. The formulation retains SOD activity in the harsh gastrointestinal tract, efficiently scavenges...
Verdiva Bio announced that enrollment for its phase 2b EVOLVE‑2 trial of VRB‑101, a once‑weekly oral GLP‑1 peptide analog for weight loss, is complete with more than 200 participants across 22 U.S. sites. The double‑blind, placebo‑controlled study will assess safety, tolerability...

Infertility has long been framed as a women's issue, yet about half of cases stem from male factors. New treatments such as Igyxos' IGX12 monoclonal antibody, which enhances follicle‑stimulating hormone activity, aim to improve sperm production and reduce the physical...

The Division of Applied Regulatory Science (DARS) operates within the FDA’s Office of Clinical Pharmacology and the Office of Translational Sciences. Its mandate is to translate emerging scientific advances into the agency’s regulatory framework, tackling complex questions that hinder drug...

Valo Health is reshaping drug development by applying AI to human causal biology, aiming to raise clinical success rates from roughly 10% to 20%. The company leverages over 17 million de‑identified patient records and Mendelian randomization to pinpoint genetically validated targets....

Novo Nordisk has struck a deal with Boston biotech Vivtex worth up to $2.1 billion to develop next‑generation oral GLP‑1 obesity and diabetes pills. The partnership leverages Vivtex’s AI‑driven gastrointestinal‑on‑a‑chip platform that can boost drug absorption by orders of magnitude. Novo...
A patient in MacroGenics' Phase 2 LINNET trial of the bispecific antibody lorigerlimab suffered grade 4 neutropenia and septic shock, leading to a fatality and prompting the FDA to place a partial clinical hold on the study. The company also reported three...

IDEAYA Biosciences announced the enrollment of the first patient in a Phase‑I dose‑escalation and expansion study of IDE034, a bispecific B7H3/PTK7 TOP1 antibody‑drug conjugate for solid tumours. The trial will assess safety, tolerability and pharmacokinetics of IDE034 as a monotherapy...
IQVIA Holdings announced an agreement to acquire five drug discovery service sites from Charles River Laboratories, adding in‑vitro capabilities, New Approach Methodologies and a small‑molecule AI platform. The assets, built on more than 20 years of data, have helped launch...
Eli Lilly’s obesity drug Zepbound achieved a 25.5% weight loss in a head‑to‑head Phase 3 trial, outpacing Novo Nordisk’s CagriSema and sending Novo’s shares down 20%. The FDA launched Rare Disease Week, issuing draft guidance for a new Plausible Mechanism Pathway that...

SteinCares has signed a strategic licensing agreement with Shilpa Biologicals to commercialize a biosimilar across Latin America. Under the deal, SteinCares receives exclusive rights to register, market and distribute the product throughout the region, while Shilpa Biologicals will complete development...
Vico Therapeutics has initiated patient dosing in an expanded European cohort for its Phase I/IIa VO659 trial, targeting Huntington's disease, spinocerebellar ataxia type 3 and type 1. The study employs a twice‑annual intrathecal regimen and will monitor safety, tolerability, pharmacodynamics and pharmacokinetics...
NorthX Biologics and Demeatriz have formed a strategic alliance to deliver an end‑to‑end platform that couples Demeatriz’s CleanCut CHO cell line development with NorthX’s GMP manufacturing capabilities. The partnership leverages a high‑titre GS‑knockout CHO cell line that carries no royalty...

The Evolution Summit, organized by Marcus Evans, will take place May 7‑8, 2026 at the Ritz‑Carlton in Fort Lauderdale. The invitation‑only event convenes senior clinical‑trial executives with innovative suppliers to discuss pressing challenges in clinical operations and drug development. Featured speakers include...

GlaxoSmithKline announced a $950 million cash acquisition of 35Pharma, a privately held biotech focused on lung diseases. The deal brings the experimental compound HS235, slated to enter pulmonary arterial hypertension (PAH) trials, into GSK’s pipeline. PAH has become a lucrative target,...

Johnson & Johnson has filed a supplemental Biologics License Application (sBLA) with the U.S. FDA for Imaavy (nipocalimab‑aahu), a monoclonal antibody intended to treat warm autoimmune hemolytic anemia (wAIHA). The filing is supported by the Phase II/III ENERGY trial, which demonstrated...

President Donald Trump used a brief four‑minute segment of his State of the Union address to push Congress to codify his Most‑Favoured Nations (MFN) drug‑pricing program. He claimed the voluntary agreements would give Americans the lowest prescription prices worldwide, though...
In July 2025 the FDA ordered a complete halt of Sarepta’s gene‑therapy Elevidys after two non‑ambulatory Duchenne muscular dystrophy (DMD) patients died, sparking a market plunge and patient access concerns. Sarepta argues that ambulatory patients, who had been receiving Elevidys...
The FDA reauthorized its rare pediatric disease priority review voucher program, bolstering a wave of regulatory incentives that include new guidance on plausible mechanisms and a Rare Disease Evidence Principles framework. Yet ultra‑rare indications still struggle to attract traditional venture...
Sarepta Therapeutics reported a blockbuster fourth quarter, with ELEVIDYS gene‑therapy sales of $384 million, surpassing guidance by $60 million, and total net product revenue of $1.79 billion for 2024, up 56% year‑over‑year. The company achieved GAAP profitability and cash‑flow positivity, confirming the financial...
Revolution Medicines reported that its lead KRAS inhibitor doraxonrasib secured breakthrough therapy, orphan drug, and a FDA National Priority Voucher, underscoring its potential in pancreatic cancer. Phase I data revealed median overall survival of 13.1‑15.6 months and a 47% objective...
Mirum Pharmaceuticals reported $521 million in 2025 net product sales, a 55% year‑over‑year increase driven by Livmarli and bile‑acid medicines, surpassing guidance. Operating expenses rose to $543 million, yet the company generated positive cash flow and ended the year with $391 million in...
ACADIA Pharmaceuticals reported record adjusted 2025 revenue of $1.08 billion, up 14% year‑over‑year, driven by strong performance of NUPLAZID and DAYBUE. The company forecast 2026 total revenue between $1.22 billion and $1.28 billion, with NUPLAZID sales expected to reach $760‑$790 million and DAYBUE $460‑$490 million....
IQVIA reported fourth‑quarter 2025 revenue of $4.34 billion, a 10.3% year‑over‑year increase, driven by strong organic growth and roughly two percentage points from recent acquisitions. Adjusted EBITDA rose 5% to $1.046 billion and adjusted diluted EPS climbed 9.6% to $3.42. The company...
United Therapeutics reported record Q4 2025 revenue of $800 million, a 7% year‑over‑year increase driven by double‑digit growth of its Tyvaso DPI inhaler and Orenitram. The company unveiled new 80‑112 µg Tyvaso DPI cartridges, expanding dosing flexibility, and highlighted unprecedented results from...
Geron Corp reported full‑year 2025 Rytelo net revenue of $184 million, with Q4 sales of $48 million, and projected 2026 revenue between $220 million and $240 million. Operating expenses are expected to dip to $230‑$240 million, a $20 million reduction year‑over‑year, while cash balances sit at...
Soleno Therapeutics reported $190.4 million in net revenue for fiscal 2025, representing less than nine months of commercial sales of its VICAT XR therapy. The company turned profitable, posting $20.9 million net income and generating $48.7 million of operating cash in Q4, ending the...
Schrödinger reported Q2 FY2025 revenue of $54.8 million, up 16% year‑over‑year, driven by 15% software growth to $40.5 million and 19% drug‑discovery growth to $14.2 million. Gross margin slipped to 68% as the mix shifted toward lower‑margin services and new predictive‑toxicology investments. Net...
A multi‑omics investigation identified molecular signatures that link alcohol craving to acamprosate treatment response in patients with alcohol use disorder (AUD). The study highlighted IL17RB genetic variants and elevated plasma TNFSF10 as robust predictors of therapeutic success, while proteomic and...
University of Toronto researchers unveiled LUMI‑lab, an AI‑driven self‑driving lab that combined a 28‑million‑molecule foundation model with active‑learning robotics to synthesize and test over 1,700 lipid nanoparticles. The system independently identified brominated lipid tails as a potent new class for...
Researchers at Northwestern University have created HYDRACs, hybrid degrading copolymers that bind and eliminate traditionally "undruggable" oncogenic proteins such as MYC and KRAS. The polymers display target‑recognizing peptides on one side and degron motifs on the other, directing the proteins...

The FDA has granted approval for Dupixent (dupilumab) to treat allergic fungal rhinosinusitis (AFRS) in adults and children six years and older, marking the first indication for this rare sinus disease. The approval follows a 52‑week trial that demonstrated significant...
New data presented at CROI 2026 show that people living with HIV who have maintained viral suppression for 25‑30 years on antiretroviral therapy regain robust HIV‑specific CD8⁺ T‑cell function. Using flow cytometry and single‑cell RNA sequencing, researchers found these cells display...

The FDA has granted traditional approvals to ten oncology drugs that originally received accelerated approval after post‑marketing studies verified clinical benefit. The list includes agents such as Braftovi, Epkinly, and Padcev, with conversion dates ranging from 2022 to 2026. These...
University of Waterloo researchers have engineered the anaerobic bacterium Clostridium sporogenes to eat solid tumors from the inside out. By inserting an oxygen‑tolerant gene and coupling it to a quorum‑sensing circuit, the bacteria survive at the tumor periphery only after...

FDA Commissioner Marty Makary argues that any drug deemed safe, non‑addictive and not prone to misuse should be sold over the counter. He cites anti‑nausea medicines, hormonal contraception and common analgesics as candidates, while urging regulators to abandon a paternalistic...

Pharmaceutical and biotech firms are mobilizing against two Trump administration proposals that would tie Medicare drug prices to those paid in other affluent nations. The initiatives – the GLOBE model for Part B physician‑administered drugs and the GUARD model for Part D...

The FDA granted traditional approval to encorafenib (Braftovi) combined with cetuximab and fluorouracil‑based chemotherapy for adult patients with metastatic colorectal cancer carrying a BRAF V600E mutation. The decision rests on the phase 3 BREAKWATER trial, which reported median progression‑free survival of...

The FDA’s Generic Drugs Program reported 217 approvals for FY‑2026, including 23 first‑time generics and 45 first‑cycle approvals. Tentative approvals reached 89, while complete responses rose to 402, reflecting a busy review pipeline. Prior Approval Supplements (PAS) saw 532 approvals,...

The FDA has published an updated list of 189 pediatric exclusivity determinations made under Section 505A of the Federal Food, Drug, and Cosmetic Act since September 2007. Each entry includes the drug name, sponsor, determination date, and links to the original Written...

The Center for Drug Evaluation and Research (CDER) released its February 2026 Guidance Agenda, outlining the draft and revised guidances it plans to develop this calendar year. The agenda features the first issuance of a Level 1 draft guidance alongside updates to...

The FDA issued a warning letter to MedisourceRx after an inspection found the facility’s compounded sterile drugs failed to meet 503B outsourcing‑facility requirements. Specific violations include marketing unapproved new drugs, misbranding due to inadequate labeling, and inadequate adverse‑event reporting. The...

Pfizer’s post‑COVID strategy pivots from vaccine and antiviral sales to rebuilding growth through oncology and metabolic assets. The 2026 guidance excludes COVID revenue, projects modest 4% operational growth, and anticipates a $1.5 billion patent‑cliff hit. To offset these pressures, Pfizer completed...
Stäubli Robotics unveiled the next‑generation Sterimove at INTERPHEX 2026, positioning it as the world’s first mobile robot certified for Grade A, B, C and D cleanroom environments. The platform combines sealed, cleanroom‑compatible construction with advanced collision‑avoidance sensing, dual emergency stops...

Sciwind Biosciences granted Pfizer China exclusive rights to commercialize ecnoglutide injection in Mainland China. Sciwind will keep the marketing authorization and handle R&D, registration, manufacturing, and supply, receiving up to $495 million in milestone payments. Ecnoglutide, a cAMP‑biased GLP‑1 receptor agonist,...
Beren Therapeutics announced that the U.S. Food and Drug Administration has accepted its New Drug Application for adrabetadex, an investigational therapy aimed at treating infantile‑onset Niemann‑Pick disease type C (NPC). The agency set a target action date of 17 August 2026 under the...

A new combination‑therapy approach for inflammatory bowel disease (IBD) aims to boost remission rates beyond the current 30 % success benchmark. By pairing agents that target distinct immune pathways, early trials show remission climbing to roughly 55 % and faster mucosal healing....
The nonprofit Every Cure is launching computational pharmacophenomics, an AI‑driven approach that systematically evaluates all 4,000 FDA‑approved drugs for the 14,000 diseases lacking treatments. Its MATRIX platform integrates massive biomedical knowledge graphs, generates graph embeddings, and ranks 75 million drug‑disease pairs,...