Tag Archives: Fierce

FDA moves to publish drug rejection letters in real time, releases new batch including Replimune’s high-profile snub  Fierce Biotech FDA Drops Another Cache of Heavily Redacted Rejection Letters, Promises Future ‘Real-Time’ Access  BioSpace In a first, FDA publishes complete response letters for ongoing drug applications  Endpoints News MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy  Yahoo Finance In major …

Fierce 50 of 2025  Fierce Pharma Source link

NCI axes funding for pediatric brain cancer trial consortium, shifts focus to broader oncology group  Fierce Biotech A major childhood brain cancer network is ending  statnews.com Pratiti Bandopadhayay: Urgent Need to Sustain Funding for Pediatric Brain Tumor Trials  Oncodaily HHS winds down pediatric brain tumor pact after 26 years, prioritizing other childhood cancer work  Endpoints News Parvati Tiwari: Advocates Express Alarm Over NCI’s Decision …

CSL to lay off up to 15% of workforce, cut R&D costs and spin out vaccine unit  Fierce Biotech CSL to Spin Off Seqirus, Cut Up to 15% of Staff in Sweeping Restructure – WSJ  The Wall Street Journal CSL Shares Slump as Disappointing Profit Eclipses Spinoff  Bloomberg.com CSL shares dive as biotech firm flags more than 3,000 job cuts — as it …

Oracle Health debuts AI-powered EHR designed as a ‘voice-first’ solution embedded with agentic AI  Fierce Healthcare Oracle Ushers in New Era of AI-Driven Electronic Health Records  Oracle Oracle rolls out AI-enabled EHR ahead of Epic user event  Modern Healthcare Oracle Brings AI Intelligence To Electronic Health Records  Yahoo Finance Cambridge Memorial Hospital Selects Oracle Health EHR to Advance Patient-Centered Care  Morningstar Source link

Moderna, working through operating cost and R&D cuts, to sideline 10% of global workforce by year-end  Fierce Pharma Moderna to slash 10% of workforce as biotech cuts costs, Covid shot sales slow  CNBC Moderna will lay off 10% of employees, Massachusetts-based company announces  CBS News Vaccine maker Moderna cuts hundreds of jobs; CEO says ‘every effort’ made to avoid layoffs  The Business Journals Moderna …

Vinay Prasad departs FDA amid conservative criticism, controversy over Sarepta gene therapy  Fierce Pharma Trump drove firing of FDA official  Politico Are we sure Vinay Prasad’s ouster is positive for biotech?  statnews.com FDA’s Prasad Exits Following Political Backlash Over Sarepta  Bloomberg.com FDA’s top vaccine official leaves post after less than four months  The Guardian Source link

IN A NUTSHELL 🌙 Scientists plan to deploy the LuSEE-Night radio telescope on the Moon’s far side to avoid Earth’s radio interference. 🔭 The mission aims to explore the Cosmic Dark Ages by monitoring low-frequency radio signals free from terrestrial noise. 🚀 Equipped with advanced technology, the telescope will operate in the Moon’s harsh environment with a substantial lithium-ion battery …

Merck joins Big Pharma cost-cutting crowd, revealing plan to save $3B annually by 2027  Fierce Pharma Merck plans $3 billion cost cuts by end of 2027, narrows full-year outlook  CNBC Merck Stock Falls After Layoff Announcement, Gardasil Sales Drop  Investor’s Business Daily Merck to Lay Off Workers and Narrows Guidance as Earnings Fall – WSJ  The Wall Street Journal Our Q2 2025 financial results  Merck.com …

Celcuity’s breast cancer combo hits goals, teeing up FDA filing  Fierce Biotech Celcuity Stock Triples on Positive Breast Cancer Treatment Study  Yahoo Finance Celcuity’s triple cancer drug combo beats AstraZeneca in halting cancer progression, shows study  Mint Celcuity posts Phase 3 win in breast cancer, setting up challenge to Novartis and Roche  Endpoints News Gedatolisib Triplet Boosts Progression-Free Survival in Breast Cancer  Curetoday Source link