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Alembic Pharma gets US FDA nod for generic Doxycycline Hyclate tablets
expresspharma
July 03, 2020
The company's product is a generic version of Almirall's Acticlate tablets in the same strengths.
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Companion Medical InPen Receives FDA Clearance for Expanded Pediatric Use
americanpharmaceuticalreview
July 02, 2020
Companion Medical, manufacturers of InPen, the only FDA-cleared smart insulin pen system, has announced that they received FDA expanded clearance for all ages to use the InPen System.
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FDA Accepts sBLA for BOTOX for Neurogenic Detrusor Overactivity
americanpharmaceuticalreview
July 02, 2020
Allergan, an AbbVie company, announced the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA) to expand the BOTOX® prescribing information for the treatment of signs and ...
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US FDA releases guidance for approval of COVID-19 vaccines
expresspharma
July 02, 2020
The US Food and Drug Administration has released guidance to approve a coronavirus vaccine. It highlights that the vaccine has to prevent or decrease disease severity in at least 50 per cent of people who are inoculated.
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US FDA Grants Orphan Drug Designation (ODD) for Prestige BioPharma’s PBP1510 Anti-PAUF Monoclonal Antibody for the Treatment of Pancreatic Cancer
B3C newswire
July 01, 2020
Prestige BioPharma Ltd. (hereinafter “Prestige BioPharma”) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreat
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FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
worldpharmanews
July 01, 2020
The U.S. Food and Drug Administration took important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines ...
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FDA to Harness Real-World Data to Inform COVID-19 Response Efforts
americanpharmaceuticalreview
July 01, 2020
The U.S. Food and Drug Administration (FDA) has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency.
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FDA Approves Pertuzumab, Trastuzumab, Hyaluronidase-zzxf Combination
americanpharmaceuticalreview
July 01, 2020
The Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO, Genentech) for subcutaneous injection.
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Roche’s breast cancer drug Phesgo secures US regulatory approval
pharmaceutical-technology
July 01, 2020
Roche has received approval from the US Food and Drug Administration (FDA) for Phesgo, in combination with intravenous (IV) chemotherapy, to treat early and metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
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FDA Issues Guidance for Clinical Trials during the COVID-19 Public Health Emergency
americanpharmaceuticalreview
June 30, 2020
The U.S. Food & Drug Administration (FDA) has issued a guidance for industry entitled, “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.”