Tag Directory / DRUGDEVELOPMENT     showing 41–60 of 84



BridgeBio Stands Tall as Phase 3 Data Put Dwarfism Drug on Track for FDA Filing / MedCity

Frank Vinluan / medcitynews - Infigratinib achieved statistically significant improvement in growth rate and body composition in a Phase 3 clinical trial that tested the BridgeBio Pharma drug in achondroplasia, the most common form of dwarfism. Regulatory submissions are planned for l…

#healthcare #pharmaceuticals #biotech #drugdevelopment #fda


Saturday, February 14, 2026, 12:22 am / permalink 19171 / 2 stories in 25 days


FDA refuses to review Moderna flu vaccine / Beckers

Ella Jeffries / beckershospitalreview - Moderna has received a refusal-to-file letter from the FDA’s Center for Biologics Evaluation and Research for its biologics license application for mRNA-1010, its investigational seasonal influenza vaccine. The letter, signed by Vinayak Prasad, MD, chief …

#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #drugdevelopment #fda


Wednesday, February 11, 2026, 10:25 am / permalink 19026 / 15 stories in 28 days


AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo / Endpoints

Anna Brown / endpoints - The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval in Europe ...

#healthcare #pharmaceuticals #biotech #drugdevelopment #fda


Monday, February 9, 2026, 12:21 am / permalink 18917 / 5 stories in 4 wks


World Cancer Day: A Global Call to Awareness and Action 2026, Part 2 / OncoDaily

oncodaily - World Cancer Day is observed annually on February 4 and was established in 2000 at the World Summit Against Cancer for the New Millennium in Paris. The initiative was led […]

#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #drugdevelopment


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Saturday, February 7, 2026, 3:21 pm / permalink 18896 / 162 stories in 4 wks


#ISC26: Bayer’s asundexian reduced ischemic strokes by 26% in Phase 3 trial / Endpoints

Ayisha Sharma / endpoints - Bayer shared more details from its unexpected win in a Phase 3 study testing its next-generation blood thinner for secondary stroke prevention. The factor XIa inhibitor, named asundexian, reduced the occurrence of ischemic stroke by ...

#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment


Saturday, February 7, 2026, 3:21 am / permalink 18873 / 2 stories in 4 wks


Eikon Therapeutics Raises $381 M in IPO to Advance Live-Cell Imaging in Cancer Drug Discovery / OncoDaily

oncodaily - Eikon Therapeutics has raised $381 million through its IPO, pricing at the top of its range in a strong sign of renewed investor appetite for biotech offerings. The South San […]

#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment


Saturday, February 7, 2026, 1:21 am / permalink 18871 / 2 stories in 4 wks


Novo Nordisk vows legal action to protect Wegovy pill / Medical Express

medicalxpress - Novo Nordisk said Thursday it would take legal action against a US chain offering a copycat of the new pill version of its Wegovy weight-loss drug.

#obesity #healthcare #pharmaceuticals #drugpricing #novonordisk #weightloss #drugdevelopment #digitalhealth


Thursday, February 5, 2026, 3:23 pm / permalink 18807 / 22 stories in 4 wks


Letters, Jan. 27, 2026: ‘A Team Canada must be assembled’ to help diversify trade / Calgary Sun

Jeffrey Morgan / calgarysun - Need to diversify I just watched a video detailing the prior commercial trading practices between Canada and the U.S. It makes me realize there is nothing more important than Canada diversifying its trade with other countries. By ‘nothing,’ I mean all pro…

#healthcare #pharmaceuticals #biotech #drugdevelopment #fda


Saturday, January 31, 2026, 2:22 pm / permalink 18622 / 9 stories in 5 wks


FDA lifts hold on one of two Phase 3 gene editing studies by Intellia / Endpoints

Lei Lei Wu / endpoints - The FDA has allowed Intellia Therapeutics to resume one of its two pivotal trials of a gene editing therapy for transthyretin amyloidosis, which is a disease caused by misfolded proteins. Intellia

#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda


Saturday, January 31, 2026, 7:22 am / permalink 18610 / 4 stories in 5 wks


#JPM26: Day 3 at the JP Morgan Healthcare Conference / Endpoints

ENDPOINTS / endpoints - It’s Wednesday at the JP Morgan Healthcare Conference, and as the sessions wind down, we’ll be keeping an eye on presentations from WuXi AppTec and AbbVie. Yesterday afternoon, our Executive Editor Drew Armstrong spoke with ...

#obesity #healthcare #pharmaceuticals #weightloss #biotech #drugdevelopment #digitalhealth


Saturday, January 17, 2026, 7:21 pm / permalink 18138 / 28 stories in 7 wks


F.D.A. Decisions on Abortion Pill Were Based on Science, New Analysis Finds / NYT

Pam Belluck / nytimes - A study of more than 5,000 pages of agency documents on mifepristone over 12 years found that agency leaders almost always followed the evidence-based recommendations of scientists.

#healthcare #pharmaceuticals #publichealth #governmentpolicy #drugdevelopment #fda


Saturday, January 17, 2026, 8:21 am / permalink 18126 / 5 stories in 7 wks


FDA rejects cancer therapy for rare post-transplant disease / Beckers

Ella Jeffries / beckershospitalreview - Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for Ebvallo (tabelecleucel). The letter, received Jan. 9, said the FDA no longer considers the single-arm ALLELE trial adequate to support …

#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #drugdevelopment #fda


Friday, January 16, 2026, 11:55 am / permalink 18057 / 2 stories in 7 wks


NVIDIA and Eli Lilly Launch $1B AI Co-Innovation Lab to Reinvent Drug Discovery / OncoDaily

oncodaily - Dave Ricks, Chair, CEO at Eli Lilly and Company, shared Eli Lilly and Company‘s post on LinkedIn, adding: “Exciting news from the JPMorgan Healthcare Conference: Lilly and NVIDIA are joining […]

#healthcare #pharmaceuticals #elililly #publichealth #biotech #drugdevelopment


Thursday, January 15, 2026, 1:23 pm / permalink 17925 / 2 stories in 7 wks


Merck Could Strike 30 Billion Deal for Revolution Medicines / OncoDaily

oncodaily - According to the Financial Times, Merck is in talks to acquire Revolution Medicines, a Redwood City, California-based cancer drug developer, in a deal that could value the company at roughly […]

#healthcare #pharmaceuticals #publichealth #biotech #mergersandacquisitions #corporatetakeover #drugdevelopment


Monday, January 12, 2026, 1:21 am / permalink 17767 / 2 stories in 1 month


Aktis Has First Biotech IPO of 2026, Raising $318M to Expand the Reach of Radiopharmaceuticals / MedCity

Frank Vinluan / medcitynews - Aktis Oncology’s IPO will support a pipeline of “miniprotein” radioconjugates that could offer advantages over other targeted radiation cancer treatments. In addition to its internal pipeline, Aktis has a discovery partnership with Eli Lilly. The post Akt…

#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment


Saturday, January 10, 2026, 10:21 am / permalink 17733 / 8 stories in 2 months


FDA rejects Corcept’s cortisol-targeting drug for Cushing’s syndrome / Endpoints

Ayisha Sharma / endpoints - Corcept Therapeutics failed to secure US approval for its drug candidate as a hormonal disorder treatment. The FDA rejected Corcept’s selective cortisol modulator relacorilant for Cushing’s syndrome, according to a company

#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda


Monday, January 5, 2026, 1:21 am / permalink 17484 / 2 stories in 2 months


Low-dose peanut therapy shown to protect children with peanut allergies / Medical Express

medicalxpress - Children with peanut allergies may not need large doses of peanut oral immunotherapy (OIT) to build protection against peanuts, finds a new study led by The Hospital for Sick Children (SickKids) and Montreal Children's Hospital.

#healthcare #publichealth #biotech #drugdevelopment


Saturday, January 3, 2026, 5:21 pm / permalink 17464 / 3 stories in 2 months


Intratumoral Bacterial Burden Drives Immunotherapy Resistance in Head and Neck Cancer / OncoDaily

oncodaily - Immune checkpoint blockade (ICB) benefits only a subset of patients with head and neck squamous cell carcinoma (HNSCC), and commonly used biomarkers (PD-L1, TMB) remain imperfect in this setting. This […]

#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment


Saturday, January 3, 2026, 11:20 am / permalink 17458 / 7 stories in 2 months


AstraZeneca bets up to $2B on Jacobio’s pan-KRAS inhibitor for cancer / Endpoints

Ayisha Sharma / endpoints - AstraZeneca is spending $100 million upfront to secure ex-China rights for an early-stage cancer drug developed by Jacobio Pharma. The UK drugmaker will be responsible for advancing and selling the oral pan-KRAS inhibitor, JAB-23E73, in ...

#pharmaceuticals #biotech #mergersandacquisitions #drugdevelopment


Saturday, December 27, 2025, 6:20 am / permalink 17306 / 7 stories in 2 months


Sanofi buys hepatitis B vaccine maker Dynavax for $2.2B; gets CRL for MS drug / Endpoints

Elizabeth Cairns / endpoints - Sanofi is set to supplement its vaccine offering with the acquisition of Dynavax Technologies for $2.2 billion in cash, the companies said Wednesday. Separately, Sanofi said the ...

#healthcare #pharmaceuticals #publichealth #biotech #mergersandacquisitions #corporatetakeover #drugdevelopment #vaccinesafety


Saturday, December 27, 2025, 2:21 am / permalink 17302 / 3 stories in 2 months


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FDA refuses to review Moderna mRNA flu vaccine application

Moderna’s mRNA flu vaccine application has been rejected by the FDA—Moderna received a refusal‐to‐file letter while accusing the agency of shifting its review standards. Multiple reports echo this regulatory setback, fueling industry concerns over consistent, transparent decision‐making. More...


FDA CRL halts AstraZeneca’s Saphnelo prefilled pen approval

AstraZeneca’s application to market its subcutaneous prefilled pen formulation of Saphnelo for treating lupus has hit a roadblock after the FDA issued a complete response letter. The decision delays the drug’s approval and raises questions about its future in the competitive immunotherapy market. More...


CMS proposes sweeping changes to ACA marketplace plan rules

CMS has proposed a major rule reshaping Affordable Care Act marketplace policies, including loosening limits on non-standard plan designs and promoting lower-premium options such as catastrophic coverage. The agency says the changes will reduce costs and boost flexibility, while critics warn they could increase confusion and weaken consumer protections—because shopping for insurance clearly wasn’t complicated enough. More...


Tenet forecasts major ACA exchange enrollment drop and financial hit

Tenet Healthcare is warning that the expiration of enhanced Affordable Care Act premium tax credits will drive a steep reduction in ACA exchange enrollment, projecting a significant revenue impact in 2026. Despite the headwind, the company says it expects earnings growth, leaning on acuity and operational performance—because nothing calms Wall Street like “we’ll make it up somewhere else.” More...


City of Hope promotes Nisha Morris to senior marketing chief

City of Hope named Nisha Morris as Senior Vice President and Chief Marketing and Communications Officer, adding marketing leadership to its executive team. The move signals a renewed focus on brand, outreach, and patient engagement as the cancer center sharpens its communication and growth strategies. More...



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