FDA Issues Series of Guidances Under Drug Competition Action Plan
The FDA released three new guidances under its Drug Competition Action Plan to streamline generic drug reviews. A final guidance clarifies the use of Information Requests and Discipline Review Letters, a revised draft updates procedures for aligning ANDA labeling with reference listed drug changes, and a final guidance outlines good ANDA submission practices. Together they aim to improve predictability, reduce review cycles, and accelerate approval of safe, affordable generics. These steps reinforce the agency’s push for greater market competition and lower drug costs.
Approved First Generic for Apokyn Injection Cartridges Requires Separately Packaged Pen
The FDA approved Sage Chemical’s generic apomorphine hydrochloride cartridges, the first generic version of Apokyn for treating "off" episodes in advanced Parkinson’s disease. The generic cartridges work only with the proprietary Apokyn Pen, which must be obtained separately through specialty...
FDA Announces Evusheld Is Not Currently Authorized for Emergency Use in the U.S.
The FDA revised Evusheld's Emergency Use Authorization on Jan. 26, 2023, limiting its use to situations where susceptible SARS‑CoV‑2 variants comprise 90% or less of national cases. With current CDC data showing over 90% of circulating variants are resistant, Evusheld...
FDA Updates Sotrovimab Emergency Use Authorization
The U.S. Food and Drug Administration revoked the Emergency Use Authorization for sotrovimab on April 5, 2022, after CDC data showed the Omicron BA.2 sub‑variant accounted for more than 50 % of cases in every HHS region. Earlier in the year the agency...
Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop - 05/18/2026
The FDA is hosting a virtual workshop on May 18, 2026 to advance novel surrogate endpoints for rare disease drug development. The event is part of the Rare Disease Endpoint Advancement (RDEA) Pilot Program, mandated by PDUFA VII and FDORA, which requires up...
New Nasal Flu Vaccine Shows Promise in Mice
Researchers at Georgia State University have engineered an intranasal influenza vaccine that uses cell‑derived extracellular vesicles (EVs) to display inverted hemagglutinin (HA) proteins. The upside‑down HA exposes the conserved stalk region while masking the variable head, prompting cross‑protective immunity. In...
Merck Adjusts Its Vaccine Supply Deal in China; Soleno Withdraws EU Application
Merck and its Chinese partner Zhifei have revised their COVID‑19 vaccine supply agreement, lowering the committed volume and adding a flexible delivery schedule to reflect waning demand. The updated contract preserves Zhifei’s exclusive distribution rights but shifts risk back to...
Jeito Capital, Prominent Biotech Investor, Raises $1.2B for Next Fund
Jeito Capital announced the close of its Jeito II fund, raising €1 billion (about $1.2 billion) – the largest capital raise ever for an independent European biopharma fund. The fund will back 15‑20 clinical‑stage drugmakers, allocating up to €150 million ($162 million) per company across...
Gilead Takes Another Big Swing at Expanding Beyond HIV
Gilead Sciences has earmarked roughly $11 billion this year for three strategic acquisitions aimed at strengthening its cancer and immunology pipelines. The moves signal a decisive pivot away from its historic reliance on HIV therapeutics toward broader biotech markets. The targeted...
AI Uncovers Significant Misdiagnoses in Carcinoma Type, Study Shows
Caris Life Sciences published a JAMA Network Open study showing its GPSai algorithm identified misdiagnoses in lung squamous cell carcinoma (SCC). Among nearly 4,000 cases, 123 (3.1%) were re‑classified as metastases from other primary sites. The AI model combined molecular,...
New Light Shed on Who Benefits Most From Weight-Loss Jabs
A new study published in Nature examined 15,000 people who used GLP‑1 weight‑loss drugs such as Wegovy and Mounjaro and found that two genetic variants linked to appetite and digestion significantly boost weight loss and increase nausea risk. Carriers of...
Genomic Drivers of Venetoclax Resistance in T(11;14) Myeloma
Genomic mechanisms of resistance to venetoclax in multiple myeloma with t(11;14)(CCND1;IGH) [Apr 2, 2026] @MKaddouraMD et al. @lbaughn @BloodPortfolio https://t.co/qmI6giPG6K #mmsm #PrecisionMedicine https://t.co/hpwUcavTg9
New Gene Therapy May Help Protect the Hearts of Patients with Friedreich's Ataxia
Lexeo Therapeutics reported early-phase results for its investigational gene therapy AAVrh.10hFXN (LX2006) in Friedreich’s ataxia–associated cardiomyopathy. In a phase 1 trial of 17 adults, a single intravenous infusion was well tolerated and produced signals of cardiac improvement, while neurological scores remained...
Wildflower Once Used to Treat Wounds and Sore Throats Shows Promise in Fighting Dangerous Superbugs
Researchers at Irish universities have demonstrated that extracts from the wildflower tormentil (Potentilla erecta) possess strong antimicrobial activity against multidrug‑resistant bacteria, including strains that cause pneumonia and urinary‑tract infections. The study identified ellagic acid and agrimoniin as the key compounds...
Lab-Grown Pineal Gland Organoids Produce Melatonin, Offering a New Sleep Model
Researchers at Yale School of Medicine have engineered human pineal gland organoids that synthesize and release melatonin. By coupling these organoids with a nerve‑cell assembloid, they demonstrated stimulus‑dependent hormone secretion and successfully restored melatonin production in mice lacking a native...
RFK Jr. Pushes to Overturn Peptide Ban, Officials Dispute Claims
RFK Jr. May Reverse a Peptide Ban He Calls “Illegal.” Former FDA Officials Say He Mischaracterized Their Work. https://t.co/glqreTHvKA https://t.co/Vi4OTryX3p
Pemivibart Shows Safety, Prevents COVID-19 in CLL Subset in Phase 3 CANOPY Trial
A phase 3 CANOPY subset analysis evaluated pemivibart, a recombinant IgG1 monoclonal antibody, for pre‑exposure COVID‑19 prophylaxis in patients with chronic lymphocytic leukemia (CLL). Among 29 CLL participants, none developed symptomatic SARS‑CoV‑2 infection over a 180‑day follow‑up, and the safety profile...
Childhood Dementia Explained by Synaptic Dysfunction, Opens New Therapies
Researchers at Flinders University used human iPSC-derived cortical neurons to model Sanfilippo syndrome, revealing that excitatory synapses become hyperactive early in development. This chronic overactivity mirrors the hyperactivity and sleep disturbances observed in affected children and appears to drive cognitive...
Lymph-Node CD8+ T Cells Amplify PD-1 Blockade in GI Cancer
PD-1 antibody-bound progenitor-exhausted CD8+ T cells in lymph nodes boost PD-1-blockade anti-tumor immunity in gastrointestinal cancer https://t.co/VKoxzy6oUq https://t.co/cQG2sLWtL2
Post-HSCT Gilteritinib May Improve Outcomes in R/R FLT3-Mutated AML
A systematic review of eight studies suggests that post‑transplant gilteritinib maintenance may markedly improve survival for patients with relapsed or refractory FLT3‑mutated acute myeloid leukemia. One‑year overall survival rates ranged from 72.3% to 100%, while two‑year overall survival hovered around...
Bausch + Lomb Receives FDA 510(k) Clearance for Bi-Blade+™ Dual-Port Vitrectomy Cutter and Adaptive Fluidics™ Advanced Update
Bausch + Lomb received FDA 510(k) clearance for its Bi‑Blade™+ dual‑port vitrectomy cutter and the Adaptive Fluidics update on the Stellaris Elite system. The new cutter operates at 25,000 cuts per minute, a 66% speed boost over the prior model, and delivers a...
Sidewinder Therapeutics Raises $137 Million to Advance Bispecific ADCs
Sidewinder Therapeutics announced a $137 million Series B round, surpassing expectations and bringing its total capital to $162 million. The round was led by Frazier Life Sciences and Novartis Venture Fund, with participation from OrbiMed, DCVC Bio, Goldman Sachs, and others. The funding...
A New Way To Target Metastatic Cancer
Researchers have unveiled a protein‑based delivery platform that homes to lymph nodes and releases an immune‑activating antibody only in the presence of metastatic cancer. The two‑step system first accumulates in nodes after bloodstream injection, then opens in the tumor’s chemical...
Noninvasive Stool DNA Testing May Outperform Colonoscopy Long-Term in Real-World CRC Screening
A new microsimulation study published in the Journal of Medical Economics finds that three rounds of next‑generation multitarget stool DNA (mt‑sDNA) testing over ten years outperform a single colonoscopy in real‑world colorectal cancer (CRC) screening. Higher patient adherence—72% versus 38%...
Can Biopeptides Reclaim Weight Loss From GLP‑1 Drugs?
Biotech startup Lembas is developing biopeptide ingredients that trigger satiety pathways, positioning them as a functional‑food complement to GLP‑1 weight‑loss drugs rather than a replacement. The short, bioavailable peptides aim to activate a cascade of gut hormones, delivering six to...
Wim Hof Method Cuts Inflammation in Multiple Sclerosis Trial
A randomized pilot study of 60 multiple sclerosis patients showed that a 12‑week Wim Hof Method program significantly reduced blood inflammatory markers, matching the effect of a structured lifestyle intervention. Researchers say the findings support the method as a safe...
Life Biosciences to Begin First Human Partial Reprogramming Trial in 2026
Life Biosciences, the Boston biotech co‑founded by David Sinclair, announced that its partial cellular reprogramming therapy will enter a first‑in‑human trial in 2026. The study will enroll 18 participants with glaucoma or non‑arteritic anterior ischemic optic neuropathy (NAION) and will...
NRH Prevents Age‑related Hearing Loss via Sirt3‑mediated Ferroptosis Suppression
NRH attenuates age-related hearing loss by suppressing cochlear ferroptosis and cellular senescence via Sirt3 activation https://t.co/MOqQblWYNM https://t.co/uhSMXRIxDK
Researchers Develop Graphene Nanodrum and AI Platform for Rapid Single-Cell Bacterial ID and Antibiotic Testing
Researchers at TU Delft, its spin‑off SoundCell, and Reinier Haga MDC have created a graphene‑based nanodrum platform that reads the nanomotion of individual bacteria and feeds the data to AI models for rapid identification and antibiotic susceptibility testing. The label‑free...
Extracellular Vesicles: A Growing Pipeline Still Searching for Validation
Extracellular vesicles (EVs), once hailed as natural delivery vehicles, have generated a sizable pipeline but no approved therapeutics yet. More than 90 clinical studies are evaluating both native MSC‑derived vesicles and engineered platforms for regeneration, gene editing, and vaccines. Companies...
MRNA Pioneer Katalin Karikó to Give Johns Hopkins Commencement Address
Nobel laureate Katalin Karikó will deliver the commencement address at Johns Hopkins on May 21. Karikó, whose mRNA work underpins the Pfizer/BioNTech and Moderna COVID‑19 vaccines, will receive a Doctor of Humane Letters. Her career, marked by early setbacks and decades‑long...
SLAS Announces the Cohort for Innovation AveNEW at SLAS Europe 2026
SLAS announced the twelve startups selected for its Innovation Ave NEW program at the SLAS Europe 2026 conference in Vienna. The cohort, representing companies from seven countries, will showcase new laboratory‑automation and discovery technologies on a dedicated exhibition floor. SLAS will cover...
Controversial Drugs Once Feared, Now Offer Hope
A decade ago, these drugs tore apart the FDA. Today, they might be some patients’ best hope Another wonderful piece from @Jasonmmast https://t.co/zOvLrdAPKi via @statnews
Insmed Scraps Skin Plans for Lung Disease Drug as Competitors Make Headway
Insmed announced it will drop development of its lung‑disease drug Brinsupri for hidradenitis suppurativa after the Phase 2b CEDAR trial showed no efficacy, with placebo outperforming both tested doses. The study also missed secondary endpoints, prompting the company to cease the...
Asthma Exacerbations Drop with Medium-Dose ICS to Biologic Switch
A recent analysis of 2016‑2023 Optum claims data shows that asthma patients who switched from a medium‑dose inhaled corticosteroid (ICS) directly to a biologic experienced markedly larger reductions in exacerbations and systemic corticosteroid fills than those who escalated to high‑dose ICS....
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...
Women Have Awaited a Revolution in Menopause. It Hasn’t Arrived.
The menopause market has surged to roughly $17 billion, driven by celebrity awareness and telehealth startups, yet scientific backing lags behind demand. Only about 6 % of private healthcare funding is allocated to women’s health, leaving many treatments unproven and clinical guidance...
Lilly’s Foundayo Nod Launches New Battle With Novo, M&A Mania Continues, Tariffs Hit Pharma
Eli Lilly received FDA approval for its oral obesity drug Foundayo (orforglipron), sparking a direct rivalry with Novo Nordisk’s Wegovy pill, which posted a modest efficacy edge in Phase 3 trials. The drug’s convenience—no water required—could differentiate it in a crowded market. Meanwhile,...
New Orexin‑Mimicking Agents Promise Disease‑Modifying Narcolepsy Therapy
Researchers announced a new class of orexin‑mimicking agents that directly address the neuropeptide deficiency underlying Type 1 narcolepsy. Highlighted in Nature Biotechnology, the drugs aim to replace missing orexin signaling, offering a potential disease‑modifying alternative to stimulant‑based symptom control.
Google Teams with Singapore’s AMILI to Launch $584 Gut‑Microbiome Nutrition App
Google and Singapore‑based microbiome firm AMILI announced the rollout of AMILI Optimise, a personalized nutrition app that blends gut‑microbiome analysis, continuous glucose monitoring and AI. The eight‑week program will cost SGD 750 (≈US $584), with a launch‑promotion price of SGD 400 (≈US $312).
First Human Data for Rubedo Life Sciences' Senolytic Drug RLS-1496
Rubedo Life Sciences reported preliminary Phase 1 data for RLS‑1496, the first topical GPX4‑modulating senolytic tested in humans. The double‑blind, vehicle‑controlled study in the EU evaluated safety, tolerability and early efficacy in plaque psoriasis, atopic dermatitis and photo‑aged skin. Results showed...
A High Dose of Wegovy Will Cost $50 Less than Zepbound
Novo Nordisk introduced Wegovy HD, a high‑dose GLP‑1 injection priced at $399 per month, $50 less than Eli Lilly’s Zepbound at $449. The new 7.2 mg dose triples the previous 2.4 mg maximum, aiming to boost weight‑loss efficacy. Novo’s shares jumped 2.7% following...
Holivita’s AI Platform ‘Our Bodies Speak a Language’ Targets Preventive Health and Aging Research
Holivita’s AI-driven platform, dubbed “Our Bodies Speak a Language,” combines foundational biological data with large‑scale clinical records to uncover hidden health patterns. Scientist Dmitry Chebanov says the system could shift medicine from reactive treatment to proactive prevention, especially in aging...
Insmed Shelves Brinsupri in Skin Disease After Mid-Stage Flop
Insmed announced it is discontinuing development of Brinsupri for hidradenitis suppurativa (HS) after a Phase 2b trial failed to meet its primary endpoint. The drug, originally pursued for sinus inflammation, had already been shelved in that indication last year. The...
Prodrug‑Tethered Lipid Nanoparticles Deliver Dual mRNA‑Drug Therapy for Solid Tumors
Researchers in Michael Mitchell’s lab at the University of Pennsylvania have engineered lipid nanoparticles that simultaneously carry mRNA and a linked drug, creating a combined immunotherapy platform for solid tumors. The new prodrug‑tethered LNPs aim to activate immune cells while...
Evotec Posts 103% Q4 EBITDA Jump as Investors Press for U.S. Listing of Just Biologics
Evotec SE reported a 103% rise in Q4 adjusted EBITDA to €58 million and a 14% revenue increase, driven by a €65 million Sandoz license payment. At the same time, activist investor MAK Capital is urging the firm to spin off its...
Know the FDA Process: Key to Biotech Investing
Investors should understand the #FDA regulatory process well. Here is a quick summary At each step investors should ask themselves if the company is developing things in a way that will satisfy the FDA Until a drug is approved the FDA is...
Falling Out of Love on Obesity Medicines?
Recent media stories claim experimental obesity drugs like retatrutide cause people to lose romantic feelings and could trigger a divorce surge. The Guardian and Telegraph pieces rely on TikTok anecdotes and indirect data from bariatric surgery, not clinical evidence. Experts...
Nurix Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate Update
Nurix Therapeutics reported Q1 2026 results, highlighting ongoing enrollment in the Phase 2 DAYBreak CLL‑201 trial and plans to launch a global Phase 3 DAYBreak CLL‑306 confirmatory study by mid‑year. The company also advanced a new tablet formulation of bexobrutideg to support an...
Bridging the Precision Gap: Accelerating Clinical Adoption of Companion Diagnostics in Oncology
Companion diagnostics (CDx) are central to precision oncology, yet clinical adoption lags due to lengthy evidence generation, regulatory hurdles, and reimbursement challenges. The article outlines three core bottlenecks—clinical validation, workflow integration, and payer coverage—that can stretch implementation timelines to a...