STAT+: GOP senator is investigating the FDA over rejections of rare disease drugs
Sen. Ron Johnson said he spoke to FDA Commissioner Marty Makary about the agency’s handling of rare disease treatments.
Prior Intimation System Under NDCT Rules Won’t Apply to Hormones, Cytotoxics, Beta-Lactams, Certain Biologics: CDSCO
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has issued a circular announcing the implementation of a "prior intimation" system for specific applications related to analytical and non-clinical testing…
GST Blow: Maharashtra Authorities Slap Rs 6.92 Crore Tax Demand on GSK Pharma
New Delhi: GlaxoSmithKline Pharmaceuticals Limited has received a tax demand order amounting to Rs 6.92 crore from the Maharashtra GST authorities for the period April 2022 to March 2023.According to…
Delhi Tramadol Premix Interception Leads Police to Illegal Drug Unit in Bihar
New Delhi: What began as a late-night interception of a drug consignment in South Delhi eventually exposed a wider counterfeit pharmaceutical network spanning several states. Investigators from the Delhi Police…
GSK Licenses Linerixibat to Alfasigma in Deal Worth Up to USD 690 Million
Bengaluru: GSK said on Monday it will receive up to USD 690 million from Italian pharmaceutical company Alfasigma for the worldwide rights to linerixibat, an experimental treatment for severe itching…
Roche Breast Cancer Drug Giredestrant Fails Late-Stage Trial Goal
Frankfurt: Roche's shares dropped more than 5% on Monday as the Swiss drugmaker failed to show that its promising breast cancer drug candidate giredestrant can help newly diagnosed patients.At 0956…
USFDA May Relax Biosimilar Testing Requirements, Development Costs Could Drop by USD 20 Million
Bengaluru: The U.S. Food and Drug Administration plans to ease testing requirements for companies developing biosimilar drugs, Bloomberg News reported, citing an agency official and internal documents.The FDA is expected…
STAT+: What’s next for RFK Jr.’s MAHA allies on vaccine policy?
A coalition of Kennedy's allies gathered to discuss vaccines, but the health secretary was rarely mentioned.
Leucovorin lacks evidence to use as autism treatment, FDA says
The FDA approves leucovorin for a rare brain disorder while retreating from top officials’ earlier insistence that it could benefit many children with autism.
Lower Cystatin C based eGFR Compared to creatinine based eGFR Linked to Worse Outcomes: JAMA
A new study published in the Journal American Medical Association showed that patients with an Cystatin C based estimated glomerular filtration rates (eGFR) value at least 30% lower than their…