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Merck Pauses Enrollment for Clinical Trials of Investigational, Once-Monthly, Oral Islatravir for Pre-Exposure Prophylaxis of HIV-1 infection AmericanPharmaceuticalReview
December 09, 2021
Merck announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor...
Merck Provides Update Trial of Once-Weekly Investigational Combination of MK-8507 and Islatravir for HIV-1 Treatment AmericanPharmaceuticalReview
November 24, 2021
Merck announced an update regarding the Phase 2 IMAGINE-DR clinical trial (MK-8507-13), which is evaluating the investigational combination of MK-8507, a non-nucleoside reverse transcriptase inhibitor...
NICE approves first long-acting injectable HIV-1 treatment EuropeanPharmaceuticalReview
November 19, 2021
The National Institute of Health and Care Excellence (NICE) has announced the publication of draft guidance recommending cabotegravir, the first long-acting injectable treatment for HIV-1 infection in adults.
Ascletis Announces Approval of Phase II Clinical Trial of ASC22 (Envafolimab) by China NMPA for Immune Restoration/Functional Cure of HIV-1 Infected Patients prnasia
November 10, 2021
Ascletis Pharma Inc. (HKEX: 1672) today announces the approval of the Phase II clinical trial of ASC22 (Envafolimab) by China National Medical Products Administration (NMPA)...
Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Opt drugs
July 08, 2021
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the company completed submission of a New Drug Application (NDA) to the FDA seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor.
Gilead seeks US approval for long-acting HIV drug lenacapavir pharmatimes
July 01, 2021
Gilead has filed its investigational long-acting HIV drug lenacapavir with the US Food and Drug Administration (FDA), seeking approval in patients with multi-drug resistant infection.
ViiV Healthcare gets FDA expanded approval for HIV-1 drug Dovato pharmaceutical-business-review
August 11, 2020
Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Dovato (dolutegravir/lamivudine) as a complete regimen to treat HIV-1 infection.
ViiV Healthcare secures Japanese approval for Dovato to treat HIV-1 infection pharmaceutical-business-review
January 19, 2020
Specialist HIV company ViiV Healthcare has secured Japanese approval for Dovato (dolutegravir 50mg/lamivudine 300mg) two-drug regimen to treat of HIV-1 infection.
ViiV Healthcare seeks EMA approval for HIV-1 drug candidate fostemsavir pharmaceutical-business-review
January 15, 2020
ViiV Healthcare has completed a regulatory filing in Europe seeking the approval for fostemsavir for the treatment of HIV-1 infection in adult patients having limited treatment options.
PIFELTRO, DELSTRIGO Receive FDA Approval for HIV-1 americanpharmaceuticalreview
September 23, 2019
Merck announced the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for PIFELTRO™ (in combination with other antiretroviral agents) and DELSTRIGO™ ...

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