FDA Expands Approval of Ribociclib to Early Breast Cancer Broad indication doubles the number of patients eligible for adjuvant CDK4/6 inhibition Sep 17, 2024
Eye Drop Company in FDA's Sights Once Again Agency sounds alarm that products still may contain amniotic fluid Sep 17, 2024
First Drug OK'd for Chronic Rhinosinusitis With Nasal Polyps in Adolescents Dupilumab lands expanded indication for upper airway disease Sep 17, 2024
Are Regulators the Root of the Problem of Serious Device Recalls? Study lays out common gaps in evidence both before and after approval Sep 16, 2024
Lebrikizumab Wins FDA Approval for Eczema 38% of patients treated with IL-13 blocker achieved clear or almost-clear skin at 16 weeks Sep 13, 2024
Approved Liver Disease Drug Has No Clinical Benefit, FDA Panel Says Agency advisors put their foot down on shaky science for Ocaliva in primary biliary cholangitis Sep 13, 2024
FDA OKs Software to Convert Apple AirPods Into Hearing Aids Designed for certain models, software can customize audio parameters Sep 12, 2024
FDA Warning on Hot Flash Drug Clinicians should perform liver blood tests before and during Veozah treatment Sep 12, 2024
FDA Expands Approval of IL-23 Drug to Ulcerative Colitis In trials, guselkumab more than doubled remission rates versus placebo Sep 12, 2024
FDA Reviewers Skeptical of Ocaliva for Rare Bile Duct Disease Agency advisory panel to examine complicated efficacy data and liver safety concerns Sep 11, 2024
Go After the Big E-Cigarette Makers, Not Vape Shops, House Members Tell FDA Lawmakers also queried officials about a menthol cigarette rule and labeling of milk alternatives Sep 10, 2024
FDA Advisors Question Potential Role of Novel Oral UTI Antibiotic Concerns about patient selection, antibiotic resistance dominated the discussion Sep 10, 2024
Experts Want FDA to Do More to Ensure Food Safety New food ingredients are a "complete black box," one expert says Sep 09, 2024
FDA Reviewers Voice Concerns Over Novel UTI Treatment Oral antibiotic has potential for inappropriate use, agency says Sep 06, 2024
Diversity Action Plans for Clinical Trials: Evaluating FDA's Draft Guidance A critical analysis reveals opportunities and challenges prior to finalization Sep 06, 2024
Nurse Goes Missing; Mpox on Airplanes; Warning on Pain Supplements Health news and commentary gathered by ľ¹ÏÖ±²¥ staff Sep 06, 2024
Teen Vaping Hits 10-Year Low in the U.S. Rate fell to under 6% this year, down from 7.7% in 2023 Sep 05, 2024
Nearly 2,000 Pharmaceutical Plants Are Overdue for FDA Checks After COVID Delays AP finds inspections are lacking nationally and abroad Sep 05, 2024
What to Know About Delta-8 and Other Common Vape Shop Drugs These substances are often sold through legal loopholes Sep 04, 2024
Neffy Is About to Hit Shelves: Considerations for Prescribing The first needle-free epinephrine option is encouraging, but we must proceed with caution Sep 03, 2024
FDA OKs Updated Novavax COVID Shot Unlike the mRNA vaccines, protein-based vaccine targets JN.1 strain Sep 03, 2024
If Alzheimer's Drug Ads Had More Data, Here's What Might Happen A slippery slope: emphasizing side effects could inhibit some people from accepting medicines Aug 30, 2024
Amid Global Emergency, FDA OKs Another Vaccine for Mpox "All effective tools" are needed to combat mpox threat, expert says Aug 30, 2024
FDA Releases Final Rule on ID Checks for Tobacco Sales Retailers will soon have to check IDs of any tobacco product customers thought to be under 30 Aug 29, 2024
Congresswomen Press FDA on Delayed Proposal to Ban Hair-Straightening Chemicals Agency has delayed the target date twice Aug 29, 2024
FDA Could Soon Limit Use of Only Drug for COVID Prevention Pemivibart may have reduced activity against growing variant KP.3.1.1, agency warns Aug 27, 2024
Ultraprocessed Foods Are Everywhere. How Bad Are They? These foods make up about 60% of Americans' diets Aug 27, 2024
FDA Clears First Automated Insulin-Delivery Tech for Type 2 Diabetes SmartAdjust technology is used in Insulet's Omnipod 5 Automated Insulin Delivery System Aug 27, 2024
FDA OKs Updated COVID Vaccines mRNA vaccines for 2024-2025 season will target the KP.2 subvariant Aug 22, 2024
Targeted First-Line Combo Approved for EGFR-Mutated Lung Cancer Lazertinib plus amivantamab improved PFS by about 7 months versus single-agent osimertinib Aug 20, 2024
FDA OKs First Syphilis Screening Test for At-Home Use Amid a surge in cases, FDA hopes at-home tests will help increase syphilis diagnosis, treatment Aug 16, 2024
FDA Expands Durvalumab Label to Operable Lung Cancer PD-L1 checkpoint inhibitor approved for use in NSCLC before and after surgery Aug 16, 2024
FDA to Challenge Food Industry to Take Up New Sodium Targets Agency hopes mean intake will drop to approximately 2,750 mg/day if companies comply Aug 15, 2024
Novel Agent for Chronic GVHD Wins FDA Approval Axatilimab achieved a 75% response rate in patients with previously treated chronic GVHD Aug 14, 2024
FDA OKs New Option for Primary Biliary Cholangitis Seladelpar improved biochemical response, ALP normalization versus placebo in phase III trial Aug 14, 2024
Blood Test for Colon Cancer: Panacea or Hype? This newly approved testing modality brings challenges and opportunities Aug 14, 2024
IL-31 Drug for Itchy Nodular Skin Disease Gets Thumbs Up From FDA Nemolizumab significantly improved itch, nodules, and sleep disturbance at 16 weeks Aug 13, 2024
FDA OKs Once-Daily Injection for Hypoparathyroidism Palopegteriparatide will be the only drug targeting underlying cause of rare endocrine disorder Aug 12, 2024
FDA Rejects MDMA-Assisted Therapy for PTSD Decision largely expected after agency advisors voted against psychedelic's safety and efficacy Aug 09, 2024