Game-Changing Vaccines, Breakthrough Drugs, and a CDC Shakeup: Biotech & Health News Roundup
In-Depth Report COVID-19 Vaccines and U.S. Public Health Upheaval Targeted Fall Boosters, But Access Tightened: U.S. health authorities approved new monovalent COVID-19 vaccines (by Pfizer–BioNTech, Moderna, and Novavax) updated for the 2025–26 season reuters.com. Unlike prior booster rollouts, the FDA restricted under-65 eligibility to those with risk factors, aligning with guidance from HHS Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic reuters.com. The change marks a sharp departure from broad eligibility in previous years. Officials and experts voiced concern that narrowing access could sow confusion over insurance coverage and leave many younger adults unprotected reuters.com reuters.com. Notably, the FDA
Biotech Breakthroughs, Pharma Shakeups & Health Alerts – Global News Roundup (Aug 19–20, 2025)
Major Corporate & Industry Announcements Clinical Trials & Drug Regulatory Updates Scientific & Medical Research Breakthroughs (Note: The above research highlights were reported in peer-reviewed journals and scientific news outlets around this time, underlining the broader scientific context during the news cycle.) Public Health & Policy Highlights Sources: Key information in this report is drawn from reputable industry and news outlets including Reuters reuters.com reuters.com, Fierce Biotech/Pharma fiercebiotech.com fiercebiotech.com, Endpoints News, STAT, and official statements from organizations like the FDA, EMA, WHO, and leading medical journals. For full details and additional context, please refer to the cited sources inline.
Biotech Breakthroughs, Pharma Power Moves & Health Shocks: News Roundup (Aug 18–19, 2025)
Biotech Sector – Big Deals, Funding, and FDA Drama Pharma & Drug Development – Approvals, Showdowns, and Safety Signals Medical & Clinical Updates – Guidelines and Safety Notices Public Health & Policy – Vaccine Rift, Medicare Cuts, and Wellness Initiatives Sources: Key news and expert quotes were gathered from Fierce Biotech fiercebiotech.com fiercebiotech.com, Fierce Pharma fiercepharma.com fiercepharma.com, Fierce Healthcare fiercehealthcare.com fiercehealthcare.com, STAT News statnews.com statnews.com, the Florida Phoenix floridaphoenix.com floridaphoenix.com, CIDRAP cidrap.umn.edu cidrap.umn.edu, and other authoritative sources as cited above. Each development is linked to its original reporting for further reading. The roundup covers events and announcements from August 18–19,
Miracle Drugs, Mega Mergers & Outbreak Alerts – Biotech & Health News Roundup (Aug 15–16, 2025)
Wegovy (semaglutide) received FDA accelerated approval to treat metabolic dysfunction-associated steatohepatitis (MASH), becoming the first GLP-1 therapy cleared for MASH in a patient population estimated at about 5% of U.S. adults, based on part 1 of an ongoing trial showing liver health improvement. Tonix Pharmaceuticals’ Tonmya, or TNX-102 SL, was approved August 15 for fibromyalgia, the first new fibromyalgia therapy in 15 years, with two Phase 3 trials showing significantly reduced daily pain versus placebo at 14 weeks and a potential peak U.S. sales of about $800 million. Pfizer’s inclacumab, a P-selectin inhibitor acquired via the 2022 $5.4 billion Global
Biotech & Health Bombshells: FDA Greenlights, Clinical Breakthroughs & Global Health Milestones (Aug 8–9, 2025)
Drug Approvals & Regulatory Developments (In Europe, regulators also made news: the EMA’s committee recommended approving darolutamide (Bayer’s Nubeqa) with hormone therapy for metastatic prostate cancer based on positive Phase 3 data onclive.com.) Clinical Trials & Research Breakthroughs Public Health & Policy Industry & Business Updates Sources: Key information and quotes in this report were drawn from Reuters news wires reuters.com reuters.com, official WHO releases who.int pharmabiz.com, and industry trade outlets including Fierce Biotech/Pharma fiercepharma.com fiercepharma.com and company statements. Each development is linked to its original source for further reading.
Top Biotechnology and Health Tech Trends in 2025: Mid-Year Update and Forecast (Updated: June 27th, 2025)
Late 2024, the first FDA-approved CRISPR-based therapy exagamglogene autotemcel (Casgevy) reached patients, with Vertex reporting $2 million in revenue from this sickle-cell gene-editing therapy in Q3 2024. Prime Medicine’s PM359 autologous CRISPR prime-edited cell therapy for chronic granulomatous disease began a Phase I/II study in 2024, with initial first-in-human data expected in late 2025. Wave Life Sciences’ RNA base-editing drug WVE-006 showed proof-of-mechanism in humans in 2024, and multi-dose trial data are anticipated in 2025. In April 2025, the FDA approved Abeona Therapeutics’ Zevaskyn, the first cell-based gene therapy for the rare skin disorder RDEB, with launch planned in Q3
Top 100 Global Biotechnology Companies Revolutionizing Science and Health
Pfizer Inc., in collaboration with BioNTech, co-developed the first FDA-approved mRNA COVID-19 vaccine, Comirnaty. Roche Holding AG is the world’s largest biotech company and a leader in oncology treatments (Herceptin) and diagnostics. Moderna, Inc. pioneered mRNA vaccine technology and its COVID-19 vaccine was among the first mRNA medicines approved, while expanding mRNA therapeutics for cancer and rare diseases. Illumina, Inc. is a market leader in DNA sequencing with platforms such as NovaSeq that enabled the concept of a $1,000 genome. CRISPR Therapeutics AG is a leading CRISPR-Cas9 gene editing company developing exa-cel for sickle cell disease and other therapies. Ginkgo