Novartis' Fabhalta has become the first treatment approved by the FDA for the ultra-rare kidney disease C3G. But analysts ...

It’s the second consecutive no-finding inspection at Unit-2, further reinforcing the company’s commitment to regulatory ...

Pharmaceutical company Shilpa Medicare Ltd on Friday (March 14) said its wholly owned subsidiary Shilpa Pharma Lifesciences ...

Dexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...

Novo Nordisk’s weight loss drug Wegovy is linked to an increased risk of hair loss, a study suggests. Meanwhile, Dexcom ...

Indoco Remedies declined 3.22% to Rs 224.20 after its Clinical Research Organization, AnaCipher, located in Hyderabad, received one Form 483 from the United States Food and Drug Administration (US FDA ...

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

noted "deficiencies in the response" from DexCom to the FDA's Form 483, which outlines observations from investigators. The ...

The filing further read the company will provide a comprehensive response to US FDA for the observations within the ...

Wells Fargo analyst Larry Biegelsen keeps an Overweight rating on DexCom (DXCM) with a $98 price target after the company disclosed that a ...

The FDA cited issues with DexCom's response to prior inspection findings, known as Form 483 observations. The inspections took place at the San Diego facility between October 21 and November 7 ...