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FDA Proposes New Rule on Reporting RequirementUnder Right to Try Act
Today, the U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide annual summary to the FDA for any eligible investigational drug they provide to eligible patients under Try Act
Jenburkt Pharmaceuticals second in India to launch Favipiravir to fight COVID-19
Jenburkt Pharmaceuticals announced the launch of antiviral drug Favipiravir (brand name Favivent) for the treatment of mild to moderate COVID-19 symptoms at a price of Rs. 39/- per tablet
Lupin gets US FDA approval for generic Glyxambi tablets
Pharma major Lupin Limited has received tentative approval for its empagliflozin and linagliptin tablets, 10 mg/5 mg and 25 mg/5 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Glyxambi tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc
Cipla ready to launch COVID-19 treatment drug favipiravir
Cipla is set to launch coronavirus COVID-19 treatment drug favipiravir, developed by the Council of Scientific and Industrial Research (CSIR) in a cost-effective process
The 80-year old Indian Pharmaceutical Association (IPA), the national professional body of pharmacists engaged in various facets of the profession of pharmacy, will soon approach the national Trade Marks Registry (TMR) for the exclusive right of its acronym, IPA. A decision to approach the TMR, claiming absolute ownership of the acronym
Ambu to launch US FDA approved sterile, single-use duodenoscope, aScope Duodeno
The Ambu, a company develop, produce and market diagnostic and life-supporting devices for hospitals and rescue services, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for aScope Duodeno on 17 July 2020 and is now ready for commercial launch as planned
FDA Revises Draft Guidance on Animal Drugs Intended for Minor Uses and Minor Species
The FDA encourages the development of safe and effective products to improve the health and well-being of all animals, including those for which there are limited options available because of the relatively small market they represent
NRDC invites proposals for COVID-19 technologies for scaling up and validation
The National Research Development Corporation (NRDC), under the Department of Science and Technology (DST), has invited proposals from the innovators under its Department of Scientific and Industrial Research (DSIR) grants-in-aid promotional programme for development of technologies for commercialization (PDTC) for up-scaling the COVID-19
CNS Pharma completes manufacturing strategy for Berubicin to treat glioma brain tumors
CNS Pharmaceuticals, a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and CNS, provided an update on the manufacturing strategy for Berubicin drug product, its lead drug candidate for the treatment of glioma brain tumors
FDA Posts Interim Results from Required Essure Postmarket Surveillance Study
Although Essure is no longer available for implantation in the U.S., the FDA remains committed to evaluating long-term safety information in women who have received the device, including data from an FDA-required postmarket surveillance study.
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