Pfizer gets CHMP opinion for Talzenna for patients with metastatic breast cancer Farhat Nasim29 April 2019 4:05 AMThe positive CHMP opinion of TALZENNA follows the medicine's approval by the U.S. Food and Drug Administration (FDA) in October 2018.New Delhi:...
USFDA nod to Teva generic nasal spray-Narcan to treat opioid overdose Medical Dialogues Bureau21 April 2019 3:57 AMThe U.S. Food and Drug Administration granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a...
USFDA issues warning letter to Rajasthan based homeopathic firm and 3 others Farhat Nasim3 April 2019 3:55 AMNew Delhi: The U.S. Food and Drug Administration (USFDA) recently posted warning letters to four companies producing homoeopathic drug products for...
Setback: USFDA rejects Sanofi, Lexicon Sotagliflozin for type 1 diabetes Farhat Nasim24 March 2019 4:15 AMThe decision comes about two months after an FDA advisory panel failed to reach a consensus over whether the once-daily oral drug, sotagliflozin,...
USFDA puts partial hold on Abbvie Venclexta clinical trials after deaths Farhat Nasim21 March 2019 4:15 AMThe clinical hold does not impact any of the approved indications for Venclexta, such as chronic lymphocytic leukaemia (CLL) or acute myeloid...
USFDA accepts Allergan license applications to expand Botox label Farhat Nasim11 March 2019 4:00 AM"The FDA's acceptance of Allergan's supplemental biologics license applications is a monumental milestone on our journey to bring new treatment...
J&J passes asbestos test, allowed to make baby powder in India Farhat Nasim1 March 2019 8:58 AMNEW DELHI: In a major relief to Johnson & Johnson(J&J), no asbestos was found in the baby powder manufactured in Baddi and Mulund plants. The...
Lupin gets USFDA nod to Methylprednisolone tablets to treat inflammation Farhat Nasim26 Feb 2019 4:20 AMThe company has received approval from the US Food and Drug Administration (USFDA) to market Methylprednisolone tablets, a generic version of...
Mylan launches Advair generic at 70 percent discount in US Farhat Nasim14 Feb 2019 3:45 AMThe treatment, the first generic of Advair, is approved in three doses and will be priced between $93.71 and $153.14, the company said.U.S: Mylan NV...
Pfizer says USFDA accepts regulatory submissions for review of tafamidis Medical Dialogues Bureau16 Jan 2019 4:05 AMPfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial...
Health Canada places restrictions on Allergan Fibroid treatment Esmya Farhat Nasim13 Jan 2019 3:30 AMThe drug is sold in Europe by Hungarian drugmaker Richter. Richter has said it considered Esmya to be a safe and effective form of treatment.Canada:...
Lupin gets USFDA nod for generic schizophrenia drug Medical Dialogues Bureau8 Jan 2019 6:40 AMNew Delhi: Drug maker Lupin Monday said it has received approval from the US health regulator to market Lurasidone Hydrochloride tablets, used in the...
