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US FDA DRUG APPROVAL
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...
FDA expands recall to all Clover Hill Dairy cheeses after listeria found in products and facilityUS food safety authorities have expanded a cheese recall due to Listeria contamination, now encompassing all products from Clover Hill Dair...
Over 58,000 cases of Aldi's Park Street Deli macaroni & cheese recalled nationwide due to undeclared soyAldi's popular Park Street Deli Macaroni & Cheese is under recall for undeclared soy. BEF Foods, Inc. has pulled over 58,000 cases nationwi...
Alfredo sauce recall: Product sold in 41 US states gets FDA's highest-risk warning over possible Salmonella contaminationAlfredo sauce recall is underway across 41 states. The US Food and Drug Administration has classified this as a Class I recall, its most se...
Maharashtra FDA bars hospitals from forcing patients to buy medicines in-houseMaharashtra's Food and Drug Administration has issued a significant directive. Hospitals and medical practitioners must now allow patients ...
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 ...
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...
FDA pulls 160,000 pounds of frozen pizza snacks from shelves in 21 states over possible metal contaminationMetal contamination frozen snack recall: A popular frozen snack, Farm Rich Pizza Cheese Crunchers, is being recalled. The US Food and Drug ...
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...
Concord Biotech shares gain 6% after USFDA approval for Tofacitinib tabletsConcord Biotech's shares surged over 6% after receiving USFDA approval for its Tofacitinib Tablets in 5 mg and 10 mg strengths. This approv...
$10. 6 billion deal: GSK to buy US cancer specialist NuvalentBritish pharmaceutical giant GSK has announced a massive $10.6 billion deal to acquire Nuvalent. This Boston-based company specializes in c...
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...
Zaynich's blockbuster potential lifts Wockhardt's long-term outlookWockhardt's novel antibiotic, Zaynich, has received USFDA approval after a 12-year effort, sparking hopes for a turnaround after years of n...
Wockhardt shares rocket 19% after FDA approval for antibiotic targeting drug-resistant infections. Check detailsWockhardt's shares surged 19% after the U.S. FDA approved ZAYNICH, a novel intravenous antibiotic for complicated urinary tract infections....
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...
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...
Zydus Therapeutics' saroglitazar drug granted priority review by US FDAZydus Therapeutics' drug saroglitazar has received priority review from the US FDA. This drug treats primary biliary cholangitis, a liver d...