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US DRUG REGULATORY AGENCY
16 fixed-dose combination drugs banned in India: Check full list hereFixed dose combination banned full list: India has banned 16 fixed-dose combination drugs, including certain antibiotics and antispasmodics...
India bans 16 fixed-dose drug combinations over safety concernsIn a significant public health initiative, the ban on 16 fixed-dose drug combinations, including various antibiotics and topical formulatio...
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...
US probes Germany's drug pricing policies, opens door to tariffsThe US has launched a trade probe into Germany's pharmaceutical pricing, alleging it unfairly burdens American commerce and forces the US t...
ED searches Bengaluru firms over alleged crypto-linked cross-border money transfers; probe estimates over Rs 2,500 croreBengaluru's Enforcement Directorate has raided six locations over alleged illegal cross-border money transfers exceeding Rs 2,500 crore usi...
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...
Who is Bobby Charles? Former Bush administration official holds lead to win Maine GOP governor primary after ranked-choice runoffBobby Charles has won Maine's Republican gubernatorial primary. He secured victory after ranked-choice voting runoffs. Charles is an attorn...
Aurobindo Pharma clears key US hurdle in Lannett acquisition, closing expected soonIndian drug giant Aurobindo Pharma is set for a major US expansion. The company has received crucial antitrust clearance from the US Federa...
US launches trade investigation into Germany over drug pricingAmerica has started a trade probe into Germany's plan to cut pharmaceutical spending. U.S. Trade Representative Jamieson Greer stated the i...
US FTC imposes divestment condition on Aurobindo Pharma's $250 mn Lannett acquisitionThe U.S. Federal Trade Commission (FTC) has mandated that Aurobindo Pharma must sell off four specific drug products. This action is a cond...
Government prescribes end to over-the-counter sale of cough syrupsEven in small villages with a population of less than 1,000, where certain remedies including cough syrups were allowed to be sold without ...
Firmly committed to building a drug-free Manipur, says CM Yumnam Khemchand SinghManipur is intensifying its fight against drugs. Chief Minister Yumnam Khemchand Singh chaired a meeting to boost intelligence sharing and ...
Indian pharma leaving generics era behind, but the Street hasn't caught up yet: Nandan KulkarniIndian pharma is shifting from generics to innovation. This transformation, extending to 2035, is creating significant new opportunities. C...
Centre mandates prescription for syrup-based medicinesChemists must now have a doctor's prescription to sell cough syrups. The government has changed the Drugs Rules, 1945. This stops over-the-...
Eli Lilly's Alzheimer's drug donanemab approved in India, but neurologists flag cost, access barriersA new drug for Alzheimer's, donanemab, has arrived in India. It aims to slow the disease's progression by clearing brain plaques. While off...
11 Indian sailors convicted, ship fined $5.3 million for cocaine trafficking in NigeriaA Nigerian court has convicted eleven Indian sailors for cocaine trafficking. Their merchant vessel was fined over five million US dollars....
UK approves Novo weight-loss pill to edge open European marketBritain's medicine regulator has approved Novo Nordisk's weight-loss pill. This makes the UK the first European market for the oral treatme...
Indian sailors, ship fined $6 million in Lagos cocaine caseA Nigerian court has convicted 11 Indian sailors and their vessel, MV Aruna Hulya, for cocaine trafficking. Authorities discovered 31.5 kil...
Regulators tighten GMP oversight of pharma plantsSeveral states have constituted dedicated multi-member teams to ensure no facility slips through the cracks before a GMP Certificate is iss...