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FDA Authorizes Test for People without Known, Suspected COVID-19 Infection
americanpharmaceuticalreview
July 31, 2020
The U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use ...
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Haryana FDA seizes 86 remdesivir vials to foil black marketing attempt
expresspharma
July 31, 2020
The State FDA informed that the team will take the investigation up to the manufacturer’s level and also work towards identifying supply chain discrepancies.
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MyoKardia Receives Breakthrough Therapy Designation for Mavacamten
americanpharmaceuticalreview
July 30, 2020
MyoKardia announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, allosteric modulator of cardiac myosin, for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy.
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Carisma Announces FDA Clearance of IND Application for Macrophage Immunotherapy
americanpharmaceuticalreview
July 30, 2020
Carisma Therapeutics announced the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the Company's lead product candidate, CT-0508.
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FDA Proposes New Rule on Reporting Requirement Under Right to Try Act
americanpharmaceuticalreview
July 30, 2020
The U.S. Food and Drug Administration (FDA) 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 an annual ...
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Grünenthal, Averitas Announce FDA Approval of QUTENZA for Neuropathic Pain
americanpharmaceuticalreview
July 29, 2020
Grünenthal announced its U.S. subsidiary Averitas Pharma, received U.S. Food and Drug Administration (FDA) approval for QUTENZA® (capsaicin) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet...
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BD Receives FDA Approval for HPV Test with Extended Genotyping Capabilities
americanpharmaceuticalreview
July 29, 2020
BD has received approval for a pre-market approval (PMA) supplement from the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity™ HPV Assay.
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The conundrum of USFDA inspections
expresspharma
July 29, 2020
Alok Ghosh, Ex-President - Global Technical Services, Lupin, shares insights on the challenges that India Pharma Inc faces with US FDA inspections and talks about measures that can help improve compliance and ...
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Haryana FDA files FIR against foreign nationals for illegal export of COVID-19 drugs
expresspharma
July 29, 2020
Haryana Food and Drugs Administration (FDA) has filed an FIR against five foreign nationals for illegal export of COVID-19 drugs mainly; Covifor (remdesivir), FabiFlu and Lopikast.
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MC2 Therapeutics Announces U.S. Food and Drug Administration Approval of Wynzora® Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) for Adults with Plaque Psoriasis
b3cnewswire
July 28, 2020
MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard of topical therapies for chronic inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has approved Wynzora® Cream (calcipotriene and