FDA Warns Yet Another Birth Tissue Company Agency says Neobiosis amniotic fluid, umbilical cord products should be regulated as drugs Jun 21, 2024
Gene Therapy for Duchenne Muscular Dystrophy Gets Expanded Approval Primary endpoint wasn't met, but other outcomes provided "substantial evidence of effectiveness" Jun 21, 2024
FDA Plans to Ease Requirements for Biosimilars' Interchangeable Status New rules would mean switching studies will generally not be needed Jun 20, 2024
Topical Agent for Hyperhidrosis Wins FDA Approval Sofpironium gel meets all primary and secondary endpoints in two vehicle-controlled trials Jun 20, 2024
Drug Shortages Keep Growing. Older, Injectable Agents Are Among the Most Vulnerable. A Q&A with Erin Fox, PharmD, MHA, on the record-breaking shortages Jun 19, 2024
FDA Approves Pneumococcal Vax Designed Specifically for Adults Covers serotypes responsible for over 80% of invasive pneumococcal disease in those 50 and up Jun 18, 2024
Two New Immunotherapy-Chemo Options Approved for Endometrial Cancer New indications for pembrolizumab and durvalumab in advanced disease Jun 17, 2024
Some Hawking Stem Cells Say They Can Treat Almost Anything. They Can't. Attorneys general in several states have sued businesses for false claims Jun 17, 2024
Secret Pentagon Anti-Vax Campaign; FDA's Tylenol Warning; E. Coli at the Olympics Health news and commentary gathered by ľֱ staff Jun 17, 2024
The Next Big Challenges for Medication Abortion Anti-abortion states continue to fight; a possible Trump victory opens door to new strategies Jun 14, 2024
FDA Took Months to React to Complaint About Abbott's Formula Factory, Audit Finds Several infants were hospitalized, and two died Jun 14, 2024
CDC Warns of Risks for ADHD Patients After Disruption of Online Adderall Prescriber Agency advises users of telehealth platform Done Global to find a new provider Jun 13, 2024
Health Groups, Others React to SCOTUS Decision on Mifepristone But the battle over abortion is far from over, they say Jun 13, 2024
Tanning Salons Are Overdue for a Regulatory Burn In the meantime, don't forget to educate patients on the risks Jun 13, 2024
New Clues to Origin of T-Cell Lymphoma After CAR-T Therapy Co-mutations, viral link, potential common susceptibility emerge from two studies Jun 12, 2024
Senators Blast Health and Law Enforcement Officials Over Illegal E-Cig Use in Teens The two best-selling disposable vapes alone generated more than $500 million in sales last year Jun 12, 2024
Was the FDA Panel Right to Recommend Against MDMA Approval? Psychedelic treatments have potential, and taking an evidence-based approach is what's needed Jun 11, 2024
Novel Drug for Rare Chronic Liver Disease Wins Conditional FDA Approval First-in-class PPAR agonist led to biochemical responses in more than 50% of patients in trial Jun 11, 2024
What to Know About FDA's Warning on Paralytic Shellfish Poisonings At least 31 people have been sickened in Oregon from eating shellfish harvested in the area Jun 11, 2024
Unanimous Thumbs-Up From FDA Advisors for Alzheimer's Drug Advisory committee decision smooths the way for eventual FDA approval Jun 10, 2024
FDA Expands Use of RSV Vaccine to Include More Adults Arexvy now approved for people 50 years and older at increased risk of serious outcomes Jun 10, 2024
'Uncertainty' Is Indeed a Bad Word: A Second Opinion on Pandemic Communication Information should be presented to the public using a three-part approach Jun 09, 2024
Here Are the Top Supreme Court Health Cases to Watch A slew of cases this term could reshape health policy Jun 08, 2024
New Tricuspid Interventions Launched into 'Broken' System Having the technology reach the right patients is a major challenge in the real world Jun 08, 2024
Telomerase Inhibitor Approved for MDS-Related Anemia Imetelstat indicated for lower-risk myelodysplastic syndromes with transfusion-dependent anemia Jun 07, 2024
FDA Reviewers Question Patient Selection for Alzheimer's Drug Candidate Agency's advisors will discuss efficacy, safety of investigational donanemab Jun 06, 2024
Can Mitral Valve Innovators Dig Themselves Out of a Rut? Current transcatheter mitral valve replacement devices a poor match for clinical need Jun 06, 2024
Juul Vaping Products' Stay of Execution Is Now More Official FDA rescinds marketing denials pending further review Jun 06, 2024
FDA Advisors Give a Hearty Thumbs Up to a COVID Vaccine Based on the JN.1 Strain "Even with some variation, there's still reasonably good protection" Jun 05, 2024
FDA Warns Company Making Stem Cell Products for Pets Safari Stem Cell claims its products can treat a range of animal diseases, FDA says Jun 05, 2024
FDA Panel Votes Against MDMA for PTSD Advisors raised concerns about efficacy, safety, trial design, misconduct Jun 05, 2024
FDA Panel to Consider Which COVID Strain to Target in an Updated Vaccine The KP.2 subvariant is now dominant in the U.S., FDA staff says in a briefing document Jun 03, 2024
'Uncertainty' Isn't a Bad Word: U.S. Agencies Must Tighten Up H5N1 Communications More effective and efficient public messaging is the need of the hour Jun 03, 2024
FDA Staff Questions Safety of MDMA Treatment for PTSD Advisory committee will weigh benefits and risks next week May 31, 2024
Company Warned Over Atypical Fat-Derived Stem Cell Product Stromal vascular fraction isn't usually sourced from donors May 29, 2024
FDA Urged to Relax Tissue Donation Restrictions for Gay, Bisexual Men Advocates say policy should be based on individualized risk assessments, "not historic bias" May 28, 2024
FDA Advisors Not Convinced Once-Weekly Insulin Is Safe in Type 1 Diabetes Risk of severe hypoglycemia was too much for panel members to overcome May 24, 2024
Blood Test for Colon Cancer Screening Secures FDA Panel's Blessing But advisors urge strong labeling emphasizing Shield test's low sensitivity for advanced adenomas May 24, 2024
House Members Question FDA Officials on Lab-Developed Tests, Missed Deadlines Agency official also seeks Congress's help with preventing device shortages May 22, 2024
