The definitive intelligence hub for biopharmaceuticals, clinical developments, stock market indicators, and biotechnology careers.
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/PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer,...
/PRNewswire/ -- Apnimed, Inc., a late stage clinical pharmaceutical company dedicated to the discovery, development, and commercialization of novel oral...
ARPA-H puts $160M into bespoke drug therapies; Biohaven switches up scientific leadership
AstraZeneca buys lung cancer drug Zegfrovy from Dizal for $1.5B
AstraZeneca, Ionis drug fails big heart disease study in major setback
/PRNewswire/ -- Atrium Therapeutics, Inc. (Nasdaq: RNA) (the "Company"), a biopharmaceutical company dedicated to delivering RNA therapeutics to the heart,...
/PRNewswire/ -- Autonomous Healthcare today announced that the U.S. Food and Drug Administration (FDA) has granted the De Novo marketing authorization for...
Avere goes public via reverse merger, pays $120M for Hansoh drug
Biogen's Alzheimer's drug lowers toxic protein, but results were mixed
/PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading patient-centric next-generation AI TechBio company and precision medicine pioneer, today...
Cellares' recent wins have opened the floodgates for the IDMO
Chai brews up $400M series C to fuel AI used by Lilly and Pfizer
FDA approves at-home starter dose of Eisai-Biogen Alzheimer's drug, includes gallery
The agency’s finalized recommendations for clinical testing of psychedelic compounds for mental health could pave the way for companies like Compass Pathways, whose psilocybin-based therapy for treatment-resistant depression could win approval as early as this year.
Huyabio's HDAC inhibitor scores in phase 3 melanoma study
Insulet, Calm to fill mental health gaps in diabetes treatment
/PRNewswire/ -- Levee Medical, a medical device innovator focused on improving outcomes for men undergoing prostate cancer surgery, today announced the...
/PRNewswire/ -- Newronika S.p.A., the Milan-based medtech company redefining deep brain stimulation therapy, has received CE Mark certification for the latest...
Over half of clinical trial recruitment hindered by inefficiency
Real Chemistry builds body of AI tools with Anatomi launch
Roche scraps two Ionis-partnered Huntington's drugs
Spero pivots to I&I via $1.1B deal with Innovent antibody
Summit sells failed antibiotic to OpenAI-backed startup
Vertex has made the largest acquisition in its history, agreeing to buy Crinetics in a $10bn deal that adds an approved therapy for acromegaly.
The U.S. Food and Drug Administration headquarters in Silver Spring, Md., on Nov. 10, 2020. Alamy The second quarter of 2026 marked a turning point for the Food and Drug Administration. Marty Makary resigned as commissioner, ending an unusually turbulent tenure marred by political influence and messy public fights with drugmakers. He wasn’t alone, as the White House swept out several leaders in a bid to end the drama that had consumed the FDA over the past year.
The trials, which were testing the tyrosine kinase inhibitor masitinib, had previously been paused. AB Science’s decision not to resume them was a matter of prioritization, not safety, the biotech said. AB Science is formally terminating three studies for immune-mediated diseases in what it characterizes as an effort to better focus the biotech’s resources on its priority programs. The French company is axing a mid-stage study in mast cell activation syndrome (MCAS), a late-stage trial in mastoc
Agenus has scrapped a phase 3 study of its combo therapy in colorectal cancer after just three months in order to go all-in on colon cancer. The biotech launched the late-stage Battman study in April to evaluate a combination of its CTLA-4 inhibitor botensilimab and an anti-PD-1 antibody balstilimab in unresectable microsatellite stable (MSS) metastatic colorectal cancer (mCRC). The aim was to enroll 830 patients across Canada, France, Australia and New Zealand.
AstraZeneca, GSK intensify China ties with Sino Biopharm deals
Dizal Pharmaceutical’s Zegfrovy is approved in the U.S. for locally advanced or metastatic non-small cell lung cancer. For $600 million upfront, AstraZeneca will gain global rights to advance and commercialize the asset.
Biogen, Eisai win FDA nod for starter dose of subcutaneous Leqembi
The failure of Roche’s Ionis-partnered tominersen in Huntington’s disease may indicate that Wave Life Sciences’ allele-specific antisense oligonucleotide candidate WVE-003 is on the right track, according to analysts at Rodman & Renshaw.
/PRNewswire/ -- BioArctic AB
The FDA last week confirmed that it would suspend the release of complete response letters pending the resolution of a citizen petition from an unnamed pharma company. Nevertheless, 14 new CRLs are now available on the agency’s portal. Just days after it confirmed a temporary suspension to its public disclosure of complete response letters, the FDA seems to have uploaded another batch of such documents to its online portal.
Through the proposal, the FDA could clear barriers to distributed manufacturing approaches intended to enhance emergency preparedness and supply chain resilience.
FDA proposes to simplify registration of US drug manufacturing
Even as the effort has met with fierce pushback from drugmakers, trade groups and opposition parties in the country’s own government, German lawmakers late Friday voted to pass health insurance reforms aiming to cut healthcare costs next year, in part by hiking up mandatory rebates that pharmas must pay on branded medicines. Still, previous resistance appears to have spared the pharmaceutical industry from at least one negative outcome in the central European nation, which often serves as a prov
In what GSK says represents a potential way to transform treatment for patients with certain types of rectal cancer, the company’s Jemperli has met the main goal of a phase 2 trial, teeing up an application with the FDA. Interim results from the phase 2 AZUR-1 study showed a “meaningful and sustained” clinical complete response rate for Jemperli at 12 months in stage 2/3 mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer, GSK said Monday.
The regulatory gears in the U.S. are increasingly creaking under the weight of new, complex drug technologies and intensifying overseas clinical trials competition from countries like China and Australia. Now, the Department of Health and Human Services is making moves to speed early drug research under a new plan dubbed Operation Trialblazer. The blueprint, which involves initiatives at multiple federal agencies, including the Food and Drug Administration and the National Institutes of Health,
Insilico Medicine Licensing deals central nervous system China Pharma platform company China Medical System Holdings (CMS) has tapped up existing partner Insilico for a 1.2 billion yuan ($177 million) collaboration aimed at a “mass-market” central nervous system (CNS) indication. The pact will involve Insilico’s AI platform PandaOmics joining forces with CMS’ “experienced R&D team and deep therapeutic expertise,” according to the July 12 release. While the companies didn’t divulge the specific C
Island Pharma drug cleared for Bundibugyo Ebola use Island Pharma has been granted the regulatory approvals needed to allow compassionate use of its antiviral galidesivir in the Bundibugyo Ebola outbreak in Uganda. The Melbourne, Australia-based biotech said it expects galidesivir to be deployed in the country this year, giving it an opportunity to generate "prospective human efficacy, safety and virological data" during an active outbreak of an Ebola virus species.
New Merck KGaA in-office requirement could lead to 70 US layoffs
NICE aims to cut funding for Amgen lung cancer drug Lumykras Lumykras, which is known as Lumakras in some markets, will no longer be covered by the Cancer Drugs Fund, according to the health technology assessment (HTA) agency. Amgen has reacted with consternation to the news that treatment with its KRAS inhibitor Lumykras will no longer be funded in England and Wales, saying the decision does not reflect experience with the lung cancer therapy since it was first made available four years ago.
NICE backs NHS use of non-invasive endometriosis tests Women with endometriosis in England could soon be offered simple non-invasive tests for diagnosis of their condition, rather than a diagnostic laparoscopy, a surgical procedure that is costly and carries risk. The debilitating condition – where tissue similar to the lining of the womb grows elsewhere in the body – affects one in 10 women of reproductive age in the UK, and causes symptoms like pain and extreme tiredness and, if untreated, can
The latest phase 2 readout for Q32 Bio’s alopecia hopeful received a warm reception from investors, backing up the biotech’s claim that the drug could offer a more durable alternative to JAK inhibitors. The data, released Monday morning, come from part B of the Signal-AA study, which enrolled 33 patients with severe or very severe alopecia areata to receive the anti-IL-7R antibody bempikibart. Patients received a 200-mg subcutaneous dose weekly for four weeks, followed by 200 mg every other week
Spero Therapeutics is putting over $1 billion on the line in exchange for rights to develop SP001, an anti-CD40L antibody, for IgG4-related disease. A Phase 2 study is planned for the second quarter of 2027.
When it comes to centers for biotech innovation and expansion, well-established locations such as Boston and South San Francisco have long dominated the field. But in the last few years, an array of other cities have emerged to stake their claim by offering government incentives, new developments, a lower cost of living and other advantages. These regions hope to ride the wave of the life sciences industry’s increased prominence since the pandemic. That attention has helped spark a global real e
Application based on long-term safety and efficacy data from three ongoing studies, including adult height and additional clinical outcomes beyond linear growth, including body proportionality and arm span evaluated over long-term follow-up FDA PDUFA target action date of Feb. 28, 2027 SAN RAFAEL, Calif., July 13, 2026 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Appli
UK first in Europe to clear Boehringer's IPF drug Jascayd Boehringer Ingelheim has the first European approval for its new idiopathic pulmonary fibrosis (IPF) therapy, Jascayd, after the UK's MHRA gave a green light to the drug. Phosphodiesterase (PDE) 4B inhibitor Jascayd (nerandomilast) has been cleared as a twice-daily, oral therapy for adults with IPF as well as progressive pulmonary fibrosis (PPF), an umbrella term for diseases caused by progressive scarring to the lungs.
Apnimed is having sweet dreams of an IPO that could fund the planned commercial launch of an obstructive sleep apnea (OSA) therapy that is currently awaiting an FDA approval decision. The therapy, called Oxnimbi or AD109, is a drug combination that targets a cause of upper airway collapse in people with OSA. Apnimed reported two phase 3 wins for AD109 in 2025 and submitted an approval application to the FDA in April this year.
For a biotech, your intellectual property is your most prized asset. But a new era of increased global competition means that strong patents, longer stealth periods and even some misdirection can be required to ensure drug developers retain an edge. A growing source of competition is China, where science can move quickly and cheaply. The Asia Society—a global organization dedicated to understanding Asia’s role in the world—reported last year that Chinese biotechs recruit trial patients two to th
Fierce Pharma reports: A $10B deal, China trial scrutiny and highlights from ADA 2026.
Fierce Pharma reports: After FDA delay, Sanofi scores subcutaneous OBI nod for Sarclisa.
BioSpace reports: Amgen continues to defend Tavneos as global regulatory pressure mounts.
Fierce Biotech reports: ARPA-H awards up to $160M for custom genetic medicines.
BioSpace reports: AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space.
Fierce Pharma reports: AZ's China deals, Kailera-Hengrui—Fierce Pharma Asia.
Fierce Biotech reports: Bausch + Lomb gives up on glaucoma eye drop hopeful after fail.
Bayer has agreed to a €3 billion capital and equity infusion from Apollo for a stake in its contraceptives business, providing balance-sheet support amid ongoing litigation and pipeline pressure.
BioSpace reports: Cancer, rare disease dominate FDA approvals in H1 2026 as AstraZeneca, J&J clean up.
FDA expanded approval of Pfizer/Seagen's Padcev plus Merck's Keytruda combination to muscle-invasive bladder cancer (MIBC), intensifying competitive pressure on AstraZeneca's checkpoint inhibitor.
FDA Newsroom reports: FDA Proposes Rule to Modernize Drug Manufacturing Registration.
Fierce Pharma reports: FDA rejects Hengrui, Elevar PD-1 liver cancer combo a 3rd time.
BioSpace reports: GSK and Hansoh’s ADC clinches late-stage win, teeing up regulatory submission in China.
GSK reported a Phase 3 win for its Hansoh-partnered antibody-drug conjugate in China, validating the partnership and setting up a regulatory submission that GSK executives framed as justifying the deal's upfront hype.
Fierce Biotech reports: Idorsia locks in new CEO after shakeup—Chutes & Ladders.
BioSpace reports: Roche scraps 2 Huntington’s studies, handing Ionis more bad news.
BioMarin is amplifying teen voices living with phenylketonuria (PKU) through a podcast series and TikTok campaign, aiming to build community around its rare-disease franchise.
AstraZeneca, Ionis slip as ATTR-CM drug fails Phase 3 (BioSpace.)
AstraZeneca's Wainua fails key heart disease trial, shares tumble
Fierce Pharma reports: BioNTech lays commercial groundwork for PD-L1xVEGF via HER2 ADC.
In the business of drug development, deals can be just as important as scientific breakthroughs. Many of today’s most lucrative medicines, from the life-saving cancer treatment Keytruda to the anti-inflammatory agent Enbrel, might not have become so without mergers and acquisitions. The end of the last decade brought record highs in pharmaceutical M&A as larger companies turned again and again to young biotechs for innovation. Often, these deals focused on cancer, rare diseases and immune system
Biotech revenue plans ‘won’t look as sunny’ after Trump tax bill (Fierce Biotech.)
BioPharma Dive reports: Cancer, immune drugmakers dominate VC funding so far in 2026.
Fate’s CAR-T prospect shows early promise in systemic sclerosis (Fierce Biotech.)
FDA Approves ENNUMO™ (pegfilgrastim-pccg), Accord BioPharma's Second Pegfilgrastim Biosimilar to NEULASTA® (pegfilgrastim) (PR Newswire FDA.)
FDA has paused the public release of Complete Response Letters after an unnamed pharma filed a citizen petition in April challenging the legality of the effort; the agency is reviewing the process.
GSK abandons Alector after back-to-back neuro stumbles (BioSpace.)
GSK cuts losses on $700M upfront Alzheimer’s collab with Alector (Fierce Biotech.)
BioPharma Dive reports: GSK ends brain drug alliance with Alector.
Fierce Biotech reports: Illumina taps new commercial, legal chiefs.
Ipsen’s Botox rival Dysport posts dual ph. 3 wins in migraine (Fierce Pharma.)
BioPharma Dive reports: Kailera says obesity pill succeeds in late-stage trial in China.
Reuters Biopharma reports: Moderna wins EU contract for RSV vaccine supply.
BioPharma Dive reports: Novartis to acquire ADC developer in a deal worth up to $1.5B.
Outbreak of diarrhea-causing parasite grows to more than 1,000 cases (STAT News.)
BioPharma Dive reports: Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal.
BioSpace reports: Psychedelics surge again as Compass, Definium provide more clinical validation.
Saol boards FDA’s resubmission boat, armed with new survival data (BioSpace.)
Fierce Pharma reports: Sobi tops bleeding disorder patient groups' reputation rankings.
Theranica Announces Landmark Coverage Milestone as Nerivio® Exceeds Half of the U.S. Insured Population (PR Newswire FDA.)
BioPharma Dive reports: Vertex to acquire Crinetics in $10B foray into endocrine disease drugs.
WuXi Biologics' MFG8 Drug Substance Facility Secures FDA PLI Approval, Advancing Commercial Supply of a Potential Blockbuster Autoimmune Therapy (PR Newswire FDA.)
Your grandparents are using cannabis. Doctors can help them do it safely (STAT News.)
5 largest VC rounds of H1 2026 (reported by BioSpace)
Affordable Care Act insurers want more premium increases as enrollment sags (STAT News.)
Allergan Aesthetics, Girls Inc. help map paths for women in STEM (reported by Fierce Pharma)
Amgen recalls almost 1 million bottles of heart failure drug over quality issue (reported by BioSpace)
Are glucose monitors a good thing for 2-year-olds? Experts look at risks, benefits (reported by STAT News)
AstraZeneca bets up to $1.9B in respiratory disease collab with Sino Biopharmaceutical (reported by BioSpace)
AstraZeneca pens $2.1B deal for challenger to Merck’s Ohtuvayre (reported by Fierce Biotech)
Bryan Johnson’s chronic disease is notoriously difficult to diagnose (STAT News.)
CureDuchenne shines a light on birthdays for DMD patients (Fierce Pharma.)
Drugmaker caught faking doctors’ petition to evade China price cut (Fierce Pharma.)
Evonik charts $100M upgrade to Indiana drug substance plant (reported by Fierce Pharma)
FDA halts release of new drug rejection letters (Fierce Biotech.)
Grünenthal receives FDA Orphan Drug and Rare Pediatric Disease Designations for Tegacorat for the Treatment of Duchenne Muscular Dystrophy (reported by PR Newswire)
Hengrui, Kailera’s oral GLP-1 clears late-stage bar in China but US results still pending (reported by BioSpace)
Lundbeck hit with untitled letter over Vyepti efficacy claims (Fierce Pharma.)
Novartis slashes New Jersey workforce again, cutting 322 employees (reported by BioSpace)
Obesity newcomer Kalohexis makes confidential IPO bid 3 months after spinoff (reported by BioSpace)
Octapharma USA Announces Expanded FDA Approval of wilate® for von Willebrand Disease Prophylaxis in Children Younger Than 6 Years (reported by PR Newswire)
Porton Advanced's UC-MSCs Cell Bank for Exosome Manufacturing Receives U.S. FDA Drug Master File (DMF) Acceptance (reported by PR Newswire)
Porton Advanced's UC-MSCs Cell Bank for Exosome Manufacturing Receives U.S. FDA Drug Master File (DMF) Acceptance (reported by PR Newswire)
Prime wins gene editing patent fight with Beam (Fierce Biotech.)
Sanofi to stop disparaging rival flu vaccine to stave off EU antitrust fine (reported by Reuters)
Satellos’ ‘intriguing’ DMD data raise hopes ahead of key readout (reported by Fierce Biotech)
Scipher picks up Chemomab’s RA drug, Nasdaq listing in merger (reported by Fierce Biotech)
Secretive AI drug hunter Xaira dips toe into dealmaking with hunt for partners (reported by BioSpace)
Tanabe pens deal to sell plants to Towa in post-buyout pivot (BioSpace.)
Through flux and fluidity, FDA keeps coming back to rare disease (reported by BioSpace)
Transplants extended survival for patients whose stage 4 lung cancer hadn’t spread, study says (reported by STAT News)
Transplants extended survival for patients whose stage 4 lung cancer hadn’t spread, study says (STAT News.)
Trial results set up Keenova to gain 3rd indication for Xiaflex (Fierce Pharma.)
Vera moves into growing kidney disease space with FDA’s accelerated IgAN nod (reported by BioSpace)
Vertex carries M&A uptick into H2, IPOs and VC raises also grow, FDA on pace despite turmoil (reported by BioSpace)
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