FDA to reassess the safety of BHA, a preservative used in popular snack foods / ABC News
go - Federal health officials will reassess the safety of a chemical called BHA used in foods including potato chips, cereals, frozen meals and meat products
#healthcare #publichealth #governmentpolicy #fda #foodsafety
Saturday, February 14, 2026, 1:21 am / permalink 19176 / 4 stories in 25 days
BridgeBio Stands Tall as Phase 3 Data Put Dwarfism Drug on Track for FDA Filing / MedCity
Frank Vinluan / medcitynews - Infigratinib achieved statistically significant improvement in growth rate and body composition in a Phase 3 clinical trial that tested the BridgeBio Pharma drug in achondroplasia, the most common form of dwarfism. Regulatory submissions are planned for l…
#healthcare #pharmaceuticals #biotech #drugdevelopment #fda
Saturday, February 14, 2026, 12:22 am / permalink 19171 / 2 stories in 25 days
FDA refuses to review Moderna flu vaccine / Beckers
Ella Jeffries / beckershospitalreview - Moderna has received a refusal-to-file letter from the FDA’s Center for Biologics Evaluation and Research for its biologics license application for mRNA-1010, its investigational seasonal influenza vaccine. The letter, signed by Vinayak Prasad, MD, chief …
#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #drugdevelopment #fda
Wednesday, February 11, 2026, 10:25 am / permalink 19026 / 15 stories in 28 days
AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo / Endpoints
Anna Brown / endpoints - The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval in Europe ...
#healthcare #pharmaceuticals #biotech #drugdevelopment #fda
Monday, February 9, 2026, 12:21 am / permalink 18917 / 5 stories in 4 wks
Letters, Jan. 27, 2026: ‘A Team Canada must be assembled’ to help diversify trade / Calgary Sun
Jeffrey Morgan / calgarysun - Need to diversify I just watched a video detailing the prior commercial trading practices between Canada and the U.S. It makes me realize there is nothing more important than Canada diversifying its trade with other countries. By ‘nothing,’ I mean all pro…
#healthcare #pharmaceuticals #biotech #drugdevelopment #fda
Saturday, January 31, 2026, 2:22 pm / permalink 18622 / 9 stories in 5 wks
FDA lifts hold on one of two Phase 3 gene editing studies by Intellia / Endpoints
Lei Lei Wu / endpoints - The FDA has allowed Intellia Therapeutics to resume one of its two pivotal trials of a gene editing therapy for transthyretin amyloidosis, which is a disease caused by misfolded proteins. Intellia
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Saturday, January 31, 2026, 7:22 am / permalink 18610 / 4 stories in 5 wks
Oregon baby is still battling infant botulism after ByHeart formula exposure / ABC News
go - A Portland, Oregon, baby got sick with infant botulism after drinking contaminated ByHeart formula donated through a program that helps poor and homeless families
#healthcare #publichealth #governmentpolicy #fda #cdc #foodsafety #infanthealth
Saturday, January 24, 2026, 7:21 pm / permalink 18380 / 7 stories in 6 wks
F.D.A. Decisions on Abortion Pill Were Based on Science, New Analysis Finds / NYT
Pam Belluck / nytimes - A study of more than 5,000 pages of agency documents on mifepristone over 12 years found that agency leaders almost always followed the evidence-based recommendations of scientists.
#healthcare #pharmaceuticals #publichealth #governmentpolicy #drugdevelopment #fda
Saturday, January 17, 2026, 8:21 am / permalink 18126 / 5 stories in 7 wks
FDA rejects cancer therapy for rare post-transplant disease / Beckers
Ella Jeffries / beckershospitalreview - Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for Ebvallo (tabelecleucel). The letter, received Jan. 9, said the FDA no longer considers the single-arm ALLELE trial adequate to support …
#healthcare #pharmaceuticals #publichealth #governmentpolicy #biotech #drugdevelopment #fda
Friday, January 16, 2026, 11:55 am / permalink 18057 / 2 stories in 7 wks
FDA moves to remove suicide warnings from GLP-1 weight loss drugs / Medical Express
medicalxpress - Federal health regulators say popular weight loss drugs like Wegovy and Zepbound do not increase the risk of suicidal thoughts, and they have asked drugmakers to remove those warnings from medication labels.
#obesity #healthcare #pharmaceuticals #elililly #novonordisk #weightloss #publichealth #governmentpolicy #fda
Thursday, January 15, 2026, 1:23 pm / permalink 17924 / 8 stories in 7 wks
Nestlé recalls baby formula over toxin risk / Medical Express
medicalxpress - Nestlé has announced a global recall of some baby formula products, saying they may contain a toxin that can cause food poisoning in infants.
#healthcare #publichealth #fda #cdc #foodsafety #productrecall #infanthealth
Saturday, January 10, 2026, 12:22 am / permalink 17716 / 2 stories in 2 months
OpenAI Launches ChatGPT Health: 5 Things to Know / MedCity
Katie Adams / medcitynews - OpenAI announced a new dedicated platform for health conversations. The company said the new offering is not intended for medical diagnosis or treatment — but rather to provide support for personal health navigation.The post OpenAI Launches ChatGPT Health…
#healthcare #publichealth #governmentpolicy #fda
Wednesday, January 7, 2026, 6:23 pm / permalink 17617 / 21 stories in 2 months
FDA rejects Corcept’s cortisol-targeting drug for Cushing’s syndrome / Endpoints
Ayisha Sharma / endpoints - Corcept Therapeutics failed to secure US approval for its drug candidate as a hormonal disorder treatment. The FDA rejected Corcept’s selective cortisol modulator relacorilant for Cushing’s syndrome, according to a company
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Monday, January 5, 2026, 1:21 am / permalink 17484 / 2 stories in 2 months
Foods with healthy-sounding buzzwords could be hiding added sugar in plain sight / Medical Express
medicalxpress - Many consumers feel pride in avoiding the glazed pastries in the supermarket and instead opting for "all natural" granola that comes packed with extra protein. Same goes for low-fat yogurts "made with real fruit," "organic" plant-based milks and bottled "…
#obesity #healthcare #weightloss #publichealth #fda
Monday, December 29, 2025, 1:21 am / permalink 17332 / 7 stories in 2 months
Novo Nordisk’s Wegovy Pill Becomes First FDA-Approved Oral GLP-1 Drug for Weight Loss / MedCity
Frank Vinluan / medcitynews - Beyond weight reduction and long-term maintenance of weight loss, the FDA decision for oral Wegovy covers use of the once-daily pill for reducing the risk of major cardiovascular events. Novo Nordisk expects the Wegovy tablet will launch in early January.…
#obesity #healthcare #pharmaceuticals #novonordisk #weightloss #drugdevelopment #fda
Tuesday, December 23, 2025, 3:22 pm / permalink 17254 / 36 stories in 2 months
FDA Approved Rucaparib for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer / OncoDaily
oncodaily - On December 17, 2025, the FDA issued a regular approval for rucaparib (Rubraca®), marking the formal conversion of its earlier accelerated authorization into full approval for BRCA-mutated metastatic castration-resistant prostate […]
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Saturday, December 20, 2025, 9:20 pm / permalink 17185 / 13 stories in 2 months
FDA Removes Key Limitation on the Use of Real-World Evidence in Regulatory Reviews / OncoDaily
oncodaily - On December 15, 2025, the U.S. Food and Drug Administration (FDA) announced a significant update to its regulatory approach regarding the use of real-world evidence (RWE) in drug and medical […]
#healthcare #pharmaceuticals #publichealth #governmentpolicy #drugdevelopment #fda
Saturday, December 20, 2025, 4:21 pm / permalink 17179 / 13 stories in 2 months
FDA approves 1st gene therapy for Wiskott-Aldrich syndrome / Beckers
Ella Jeffries / beckershospitalreview - The FDA has approved Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome, a rare and life-threatening immune disorder. Waskyra is indicated for pediatric patients 6 months and older, as well as adults with Wiskott-Aldri…
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Monday, December 15, 2025, 2:21 am / permalink 16954 / 4 stories in 2 months
A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes / Fierce
fiercehealthcare - Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.
#healthcare #publichealth #governmentpolicy #biotech #drugdevelopment #fda #vaccinesafety
Thursday, December 4, 2025, 10:23 am / permalink 16565 / 10 stories in 3 months
FDA approves all ages gene therapy for spinal condition / Beckers
Ella Jeffries / beckershospitalreview - The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec-brve), the company’s first and only gene replacement therapy for spinal muscular atrophy in children 2 and older, as well as for teens and adults. The therapy is designed to address the genetic …
#healthcare #pharmaceuticals #publichealth #biotech #drugdevelopment #fda
Monday, December 1, 2025, 4:21 am / permalink 16428 / 2 stories in 3 months