Zydus gets zero USFDA observations for Ahmedabad animal health drug manufacturing facility Ruchika Sharma3 Jun 2023 11:52 AM ISTAhmedabad: Through a recent BSE filing, Zydus Lifesciences Ltd. has informed that the US Food and Drug Administration (USFDA) has concluded the...
Lupin arm Novel Labs bags USFDA nod for Diazepam Rectal Gel Ruchika Sharma2 Jun 2023 12:30 PM ISTMumbai: Pharma major, Lupin Limited, has announced that its wholly-owned subsidiary, Novel Laboratories Inc., based in Somerset, New Jersey, has...
USFDA inspection: Caplin Steriles gets 4 observations for Gummidipoondi site Ruchika Sharma1 Jun 2023 2:42 PM ISTChennai: Caplin Steriles Limited has announced that the United States Food and Drug Administration (USFDA) has issued four...
Bristol Myers Squibb gets USFDA priority review for lung cancer treatment Repotrectinib Ruchika Sharma1 Jun 2023 2:00 PM ISTNon-small cell lung cancer is one of the most common types of lung cancer, representing up to 84% of diagnoses.
Pfizer bags USFDA nod for RSV vaccine Abrysvo for older adults Ruchika Sharma1 Jun 2023 12:00 PM ISTThe FDA's decision is based on the data from the pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder adults...
Lupin gets USFDA nod for generic equivalent of Ocaliva Tablets Ruchika Sharma31 May 2023 5:30 PM ISTMumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S....
Janssen seeks USFDA nod for single tablet combination therapy of Macitentan, Tadalafil for Pulmonary Arterial Hypertension Ruchika Sharma31 May 2023 3:30 PM ISTRaritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a New Drug Application (NDA) to the U.S. Food...
Jubilant Pharmova arm gets OAI status from USFDA for Montreal facility Ruchika Sharma30 May 2023 11:48 AM ISTThe US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Janssen Milvexian gets USFDA fast track designation for Ischemic Stroke, Acute Coronary Syndrome, Atrial Fibrillation Ruchika Sharma26 May 2023 3:15 PM ISTRaritan: The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that all three prospective indications for milvexian, an ...
USFDA nod to Pfizer Paxlovid for adult patients at high risk of progression to severe COVID 19 Ruchika Sharma26 May 2023 1:30 PM ISTPAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy.
Aurobindo Pharma arm gets USFDA nod for Carboprost Tromethamine Injection Ruchika Sharma26 May 2023 11:30 AM ISTCarboprost Tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional...
Abbott bags USFDA nod for TactiFlex Ablation Catheter to treat abnormal heart rhythm Ruchika Sharma24 May 2023 1:30 PM ISTTactiFlex catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall.
