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Pfizer and BioNTech’s Comirnaty Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19

(BUSINESS WIRE) August 27, 2025 -- Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”)...

Repatha Now Indicated for Adults at Increased Risk for Major Adverse Cardiovascular Events Due to Uncontrolled LDL-C

THOUSAND OAKS, Calif., Aug. 25, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA)...

FDA Approves Dawnzera (donidalorsen) as the First and Only RNA-targeted Prophylactic Treatment for Hereditary Angioedema

(BUSINESS WIRE)--Aug. 21, 2025-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA)...

Chatbots Do Well Responding to Low- and High-Risk Suicide Questions

Popular chatbots generally perform well in responding to very high-risk and very low-risk questions about suicide, according to a study published online...

Most Adults Miss Symptoms of Hip Problems

Many adults do not recognize symptoms of hip problems, although a majority do understand that a clicking sensation in the hip is a sign of a hip problem,...

HHS, Department of Education Call for Integration of Nutrition Education in Medical Schools

The U.S. Department of Health and Human Services and Department of Education announced an initiative Wednesday urging medical schools to integrate nutrition...

Variables Associated With Heart Failure Compared for Men and Women

Asthma, depression, anxiety, and hypothyroidism are associated with heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced...

Overweight Status Appears to Reduce Mortality in Seniors Undergoing Elective Surgery

Older adults (aged 65 years and older) with overweight who undergo elective surgery have a lower rate of 30-day all-cause mortality compared with those...

CDC Director Susan Monarez Fired Less Than a Month Into Role

THURSDAY, Aug. 28, 2025 — Susan Monarez is out as director of the U.S. Centers for Disease Control and Prevention (CDC) — less than one month...

FDA Approves Updated COVID Vaccines, But Fewer People Will Be Eligible

THURSDAY, Aug. 28, 2025 — The U.S. Food and Drug Administration (FDA) has approved updated COVID-19 vaccines for the fall season but has restricted...

School Connection May Protect Teens From Depression Linked To Bullying

THURSDAY, Aug. 28, 2025 — Teens who feel connected to their school may be better protected from depression linked to bullying, new research suggests. The...

FDA Removes Risk Evaluation and Mitigation Strategy (REMS) Program for the Antipsychotic Drug Clozapine

FDA Removes Risk Evaluation and Mitigation Strategies (REMS) Program for the Antipsychotic Drug Clozapine Neutropenia Risk Remains, but REMS No Longer...

Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling

August 27, 2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets...

Regeneron Announces Positive Results from Phase 3 Trial of Cemdisiran in Generalized Myasthenia Gravis

 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the primary and key secondary endpoints were met in the Phase 3 NIMBLE trial...

Lilly's Oral GLP-1, Orforglipron, is Successful in Third Phase 3 Trial, Triggering Global Regulatory Submissions This Year for the Treatment of Obesity

Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the Phase 3 ATTAIN-2 trial, evaluating orforglipron, an investigational...

Mississippi Declares Public Health Emergency Over Infant Deaths

MONDAY, Aug. 25, 2025 — Mississippi has declared a public health emergency after reporting its highest infant death rate in more than a decade. In...

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live)

Today the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s live-attenuated...

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Latest FDA New Drug Approvals

  • Dawnzera Dawnzera (donidalorsen) is a prekallikrein-directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary...
  • Tonmya Tonmya (cyclobenzaprine hydrochloride) is a sublingual formulation of cyclobenzaprine hydrochloride indicated for the treatment of...
  • Papzimeos Papzimeos (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults...

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