Searched for
US FDA REGULATIONS
Plan in the works to let hospitals import med equipment directlyIndia's drug regulator is proposing to allow hospitals to directly import advanced medical equipment like MRI and CT scanners, bypassing cu...
Alembic Pharma gets tentative nod from USFDA for generic cancer drugAlembic Pharmaceuticals has secured tentative approval from the USFDA for its generic Binimetinib tablets. This marks a significant step fo...
USFDA concludes inspection at Jubilant HollisterStier's Spokane plant with 8 observationsJubilant Pharmova announced its US subsidiary, Jubilant HollisterStier LLC, underwent a USFDA inspection. The facility in Spokane, Washingt...
Dabur India shares in focus after US FDA places drugs from Silvassa plant under import alert. Here’s whyDabur India shares are set to be in focus after the US FDA issued an import alert on drugs manufactured at its Silvassa plant, citing data ...
US drug regulator issues import alert for drugs made at a Dabur India plantThe US Food and Drug Administration has placed Dabur India's factory on an import alert. This action follows an inspection that revealed si...
Govt outlines next phase of pharma growthThe government highlighted its achievements, reforms, and policy initiatives, aiming to boost exports from $31 billion to $50 billion by 20...
Trump tariffs changed taste of foods in U.S? Label checking reveals shocking detailsTrump Tariffs have grabbed headlines and become the topic of discussion around the world. Now there is a reality-check on the food ingredie...
US stocks: Fulcrum shares plummet over 50% after scrapping lead sickle-cell drug on FDA concernsThe oral drug, pociredir, was being tested to treat sickle-cell disease, an inherited blood disorder that can trigger pain, anemia and or...
FDA approval puts Wockhardt’s Zaynich in $9 billion antibiotics marketWockhardt's new antibiotic, Zaynich, has received US FDA approval. This drug uses a novel mechanism to fight drug-resistant bacteria. It ta...
More macro headwinds on the cards? Tackle them with core principles: 6 pharma stocks with upside potential of up to 28%There was a time when the Indian pharma story in the US was almost entirely about inspection risk. The US FDA would inspect a plant, a warn...
Wockhardt secures US FDA approval for antibiotic ZaynichWockhardt's novel antibiotic, Zaynich (cefepime and zidebactam), has received US FDA approval for complicated urinary tract infections. Thi...
U.S. drug regulator flags data integrity, maintenance lapses at Dabur India plantThe U.S. FDA has identified significant data integrity and manufacturing lapses at a Dabur India plant following a January inspection. Find...
Tata Elxsi unveils AnaTel, an AI-powered platform for healthcare software engineering and regulatory complianceTata Elxsi’s AnaTel reflects the growing shift toward AI-native healthcare software engineering, bringing AI-driven automation into regulat...
What is mifepristone, and why is it used? Court restricts abortion access by blocking mailing of abortion pill in USWhat is mifepristone, and why is it used? A federal appeals court has restricted access to mifepristone by blocking mailing of prescription...
Compliance squeeze, global scrutiny redefine India’s $30 billion pharma export playbookAs global markets prioritise quality and regulatory trust, India’s pharma sector is recalibrating beyond its traditional cost advantage.
India-New Zealand FTA to be signed on Monday, says PM Christopher LuxonIndia and New Zealand will sign a Free Trade Agreement on Monday, April 27. This landmark deal aims to boost bilateral trade significantly....
Has Donald Trump administration made Marijuana legal for medical or recreational use in U.S.? Shares of cannabis firms jump big in U.S. Stock MarketCannabis decision by the Federal Government Iargely legitimizes medical marijuana programs in the 40 states that have adopted them.
Drugmaker Granules to tighten oversight after US FDA warning, executive saysThe company, which is globally one of the largest paracetamol makers and a major player in the active pharmaceutical ingredients market, de...
Indian drugmaker Granules to tighten oversight after US FDA warning, exec saysAmid growing scrutiny from the U.S. FDA over documentation practices and contamination issues, Granules India is reinforcing its manufactur...
UK, Australia regulators seek details of US findings on Ranbaxy’s Mohali plantA spokesperson from UK drug regulator told ET that the agency is in touch with the US FDA to assess how this ban would affect Ranbaxy drugs...