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U.S. DRUG REGULATOR
India’s rising export champion faces a critical credibility testIndia's seafood exports are soaring, reaching record highs and aiming for $30 billion within five years. Despite overcoming US tariffs and ...- Banned substance in shrimp: Vet shops under close watchIndia's top drug regulator is cracking down on veterinary shops. This action follows a significant rejection of shrimp exports to major mar...
- Scientists discovered a forgotten 'yellow brick road' at the bottom of the oceanScientists aboard the Nautilus exploration vessel were astonished to discover a remarkably paved 'road' on the ocean floor near Hawaii. Thi...
- Avammune’s big bet: Why the future of cancer treatment may come in a pillAs global oncology races toward next-generation therapies, Avammune Therapeutics is betting on affordable, orally administered immunotherap...
- Trump orders tighter banking scrutiny of undocumented migrants, warns of account seizuresPresident Trump announced an executive order to shut down and seize funds from bank accounts supporting illegal immigration or holding welf...
- 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...
- Johnson & Johnson prostate cancer drug reduces risk of cancer spread and death in late-stage studyThe study, which followed patients for over five years, found that those who received the regimen were nine times more likely to have lit...
- 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...
- What to know about the Bundibugyo virus, a species of Ebola causing an outbreak in CongoA rare Bundibugyo virus outbreak in Congo, with over 200 deaths, lacks specific treatments or vaccines, complicating response efforts. Whil...
- 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...
- GSK's chronic hepatitis B drug helps one in five achieve functional cure in key studiesGSK's experimental hepatitis B drug, bepirovirsen, showed promising results in late-stage studies, with nearly one in five patients achievi...
- Gene therapy for cholesterol: Initial test results cheerA new gene editing medicine, VERVE-102, offers hope for millions with heart conditions. Eli Lilly's drug showed significant reductions in b...
- Venus Remedies gets Saudi FDA approval for speciality oncology therapyVenus Remedies Limited has secured its first global marketing authorization for its specialty oncology therapy, Plerixafor, from the Saudi ...
- Alembic gets USFDA nod for generic levothyroxine sodium tabletsAlembic Pharmaceuticals has secured final approval from the US health regulator for its generic levothyroxine sodium tablets. This medicati...
- Govt flags ‘high-risk’ crypto system in note to Parliamentary panelIndia's virtual digital asset sector is now high risk. Intelligence reports reveal extensive illegal activities including drug trafficking ...
- Top cases on the United States Supreme Court's docketThe U.S. Supreme Court is reviewing significant cases. These cases cover voting rights, presidential authority, immigration policies, and g...
- Alembic Pharma gets USFDA tentative nod for generic prostate cancer drugAlembic Pharmaceuticals has secured tentative approval from the USFDA for its generic version of Darolutamide tablets, targeting prostate c...
- Eli Lilly halts India obesity awareness campaign after regulatory scrutiny, seeks rules clarityEli Lilly halted its obesity awareness campaign in India. The nation's drug regulator cautioned the company about potential violations. The...
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