Tweet at me at @kdooleyyoung if these links don’t work or if you want to read a story and need a PDF. Also, here’s my timeline of many interesting events in FDA history.
Panel: MRD Tests May Speed Myeloma Tx Approvals, April 15, 2024. MDEdge Hematology.
Researchers Seek to Block Use of FDA-Approved OUD-Risk Test, April 5, 2024. Medscape
FDA’s Cancer-Drug Rebuff Hints at Stricter Stance, March 27, 2024. MDedge Hematology News
Myeloma: FDA Advisers Greenlight Early CAR-T, March 18, 2024. MDEdge Hematology News.
FDA Approves Florida Plan to Import Drugs from Canada, Jan. 5, 2024. WebMD.
Grail Gets FDA OK for Study of Cancer Blood Test, Nov. 27, 2023. Medscape Medical News.
FDA Panel Voices Concerns Over Two Lymphoma Accelerated Approvals, Nov. 17, 2023. Medscape Medical News
Lack of Medical Device Tracking Leaves Patients Vulnerable, Sept. 27, 2023. Medscape Medical News.
FDA to Step Up Oversight of Cosmetics, Assess ‘Forever Chemicals’, , Aug. 29, 2023. Medscape Medical News.
Are AI-Powered Skin-Check Tools on the Horizon for Dermatologists, PCPs?, Aug. 1, 2023. Medscape Medical News.
FDA Panel Backs New COVID Booster Focusing Only on XBB Variants, June 15, 2023. Medscape Medical News.
Panel Backs Limited New Olaparib Use in Prostate Cancer, May 1, 2023. Medscape Medical News.
CRC Blood Tests: A Future Without Screening Colonoscopies?, April 5, 2023. Medscape Medical News.
FDA Panel Backs Shift Toward One-Dose COVID Shot, Jan. 27, 2023. Medscape Medical News.
Approvals and Withdrawals: Inside the Cancer Drug Terrain of 2022, Jan. 23, 2023. Medscape Medical News.
FDA Panel Votes Against Omburtamab for Rare Pediatric Cancer, Nov. 1, 2022. Medscape Medical News.
FDA Panel Recommends Withdrawal of Makena for Preterm Birth, Oct. 19, 2022. Medscape Medical News
FDA Panel Finds Duvelisib Risks Outweigh Benefits in CLL/SLL, Sept. 26, 2022. Medscape Medical News.
How and when the FDA seeks outside advice on drug approvals, Sept. 23, 2022. Association of Health Care Journalists website.
Follow-up Trial of Myeloma Drug ‘Flopped,’ Says FDA Panel, Sept. 23, 2022. Medscape Medical News.
FDA Panel Rebuffs Poziotinib for NSCLC in 9-4 Vote, Sept. 23, 2022. Medscape Medical News.
Evaluating concerns about accelerated FDA drug approvals, Sept. 7, 2022. Association of Health Care Journalists website.
Will the FDA get more tools for handling accelerated drug approvals? Sept. 6, 2022. Association of Health Care Journalists website.
Rise in naloxone costs for uninsured, a significant access barrier to life-saving drug, Aug. 29, 2022. Association of Health Care Journalists (AHCJ) website.
Devices to Detect Skin Cancer: FDA Advisers Offer Mixed Views, Aug. 1, 2022. Medscape Medical News.
FDA Panel Urges Caution With Skin-Cancer-Detecting Tools, July 29, 2022. Medscape Medical News.
FDA Panel Backs Adding Omicron Component to COVID Boosters, June 28, 2022. Medscape Medical News.
Amylyx may get rare second chance with FDA panel, July 26, 2022. Association of Health Care Journalists website.
Three tips for covering FDA advisory committee meetings, July 26, 2022. Association of Health Care Journalists website.
FDA Panel Backs Moderna, Pfizer COVID Vaccines for Young Children, June 15, 2022. Medscape Medical News.
FDA Panel Strongly Backs Protein-Based Novavax COVID Vaccine, June 7, 2022. Medscape Medical News.
What the FDA and a major report say about safety of abortion pills, May 31, 2022. Association of Health Care Journalists website.
FDA, AMA Prepare for Potential COVID Shots for Kids Younger Than 6, May 23, 2022. Medscape Medical News
“The need for speed and safety: A primer on the FDA’s drug approval pathways,” STAT Report, May 2022
FDA Panel: Concerns Over PI3K Inhibitors in Blood Cancers, April 22, 2022. Medscape Medical News.
Lawmaker Seeks Deadlines on FDA Accelerated Drug Approvals, March 18, 2022. Medscape Medical News.
Clozapine Interrupted: APA, Others Seek FDA Forum on REMS, March 3, 2022. Medscape Medical News.
Biden’s FDA Chief Nominee Narrowly Wins Senate Confirmation, Feb. 15, 2022. Medscape Medical News.
FDA Panel Rejects Sintilimab Clinical Trial Data From China, Feb. 11, 2022. Medscape Medical News.
Califf Plans Work on Opioids, Accelerated Approvals on Return to FDA, Dec. 14, 2021. Medscape Medical News.
Tracking the Senate confirmation process for next FDA chief, Nov. 17, 2021. Association of Health Care Journalists website.
FDA warns that breast implants are not “lifetime devices”: Tips for covering this story, Nov. 2, 2021. Association of Health Care Journalists.
FDA Approves Avacopan for Rare ANCA Autoimmune Disease, Oct. 08, 2021. Medscape Medical News.
Paying Less for Drugs With Problematic Approvals, Sept. 29, 2021. Medscape Medical News.
Cut Aducanumab Cost, Speed Confirmatory Research, ICER Says, Aug. 5, 2021. Medscape Medical News.
FDA’s Accelerated Drug Approval Process Under Investigation by OIG, Aug. 5, 2021. Medscape Medical News.
No Net Benefit of Aducanumab for Alzheimer’s Disease, Expert Panel Rules, July 16. Medscape Medical News.
Controversial Approval Puts Lack of Permanent FDA Chief in Spotlight, June 23, 2021. Medscape Medical News.
Biden Budget Requests Steep Increases for NIH, CDC, SAMHSA, May 28, 2021. Medscape Medical News.
FDA panel narrowly backs avacopan approval, May 7, 2021. MD Edge Rheumatology News.
FDA Targets Cancer Indications That Fail to Prove Clinical Benefit, March 17, 2021. Medscape Medical News.
J&J COVID-19 Vaccine Wins Unanimous Backing of FDA Panel, Feb. 26, 2021. Medscape Medical News.
NIH, FDA Sought Help From State to Get COVID Vaccines for Staff, Feb. 12, 2021. Medscape Medical News.
New Trump Administration Policies for FDA Under Fire, Jan. 15, 2021. Medscape Medical News.
FDA Warns of False Negative COVID Tests From Virus Mutations, Jan. 8, 2021. Medscape Medical News.
FDA Encourages Use of Extra Doses of Pfizer COVID Vaccine Vials, Dec. 23, 2020. Medscape Medical News.
Moderna COVID-19 Vaccine Wins Decisive Recommendation From FDA Panel, Dec.17, 2020. Medscape Medical News
FDA Panel Overwhelmingly Backs Emergency Authorization for Pfizer COVID Vaccine, Dec. 10, 2020. Medscape Medical News.
CDC Panel Delves Into Priorities for COVID Vaccine Distribution, Nov. 25, 2020. Medscape Medical News.
COVID-19 Vaccine Standards Questioned at FDA Advisory Meeting, Oct. 22-23. Medscape Medical News.
‘Celebration’ Will Be ‘Short-Lived’ if COVID Vaccine Rushed: Experts, Medscape Medical News, Oct. 1, 2020.
Reporting on coronavirus vaccines: 5 tips to help journalists inject audiences with the facts
Coronavirus vaccines: We address 3 big questions about safety, distribution and adoption
Pharma Execs Give Congress ‘Honest Assessment’ on COVID Vaccines, July 21, 2020. Medscape Medical News.
FDA panel rejects new empagliflozin indication for type 1 diabetes, MD Edge | Endocrinology, Nov. 13, 2019. Same-day coverage of advisory committee meeting.
Lumateperone schizophrenia drug seems to hit snag, July 30, 2019. MDEdge | Psychiatry.
FDA Panel Rebuffs Broad Indication for Descovy for HIV PrEP, Aug. 8, 2019. Medscape Medical News.
FDA Allows Continued Sales of Textured Breast Implants, May 3, 2019. Medscape Medical News.
More Info on Risks of Breast Implants Needed, Says FDA Panel, March 27, 2019. Medscape Medical News.
Head of National Cancer Institute to Serve as Interim FDA Chief, March 13, 2019. Medscape Medical News.
Physicians Call for Action on Root Causes of Drug Shortages, Feb. 15, 2019. Medscape Medical News.
Congress Passes Right-to-Try Bill, May 22, 2018. Medscape Medical News.
FDA Panel Urges Rejection of Hyperbilirubinemia Drug for Newborns, May 5, 2018. Medscape Medical News.
FDA Panel Gives Partial Nod to Rheumatoid Arthritis Drug Baricitinib , April 24, 2018, Medscape Medical News.
FDA Chief Highlights Cost as Obstacle to Cancer Treatment , Medscape Medical News, April 12, 2018.
Senate Rejects Bid for Quick Action on Right-to-Try Bill, Medscape, March 23, 2018.
FDA Panel Backs Proposed Tofacitinib Dosing for Ulcerative Colitis, Medscape, March 9, 2018.
FDA Panel Gives Nod to New Blincyto Use in ALL, Medscape, March 8, 2018.