Antiviral

ClinicalAugust 5, 2026

Intranasal RNA therapy shows promise against SARS-CoV-2 with dual-targeting approach

A novel intranasal nanomedicine targeting SARS-CoV-2 shows partial viral load reduction in mice, utilizing hpDNAs and baicalein.

RegulatoryAugust 2, 2026

FDA Approves Supplement for VEKLURY (Remdesivir) by Gilead Sciences

The FDA has approved a supplemental application for VEKLURY (remdesivir) submitted by Gilead Sciences.

RegulatoryJuly 29, 2026

FDA Approves Supplemental Application for KALETRA by AbbVie

The FDA has approved a supplemental application for KALETRA, a combination of Lopinavir and Ritonavir, submitted by AbbVie.

RegulatoryJuly 29, 2026

FDA Accepts Supplemental Application for Norvir (Ritonavir) by AbbVie

The FDA has accepted a supplemental application for Norvir (Ritonavir) submitted by AbbVie.

RegulatoryJuly 25, 2026

FDA Warns of Serious Liver Injury Risk with Mavyret, Zepatier, and Vosevi in Advanced Liver Disease

FDA reports rare cases of worsening liver function or liver failure in patients with advanced liver disease treated with Mavyret, Zepatier, or Vosevi.

RegulatoryJuly 22, 2026

FDA Accepts Application for XOCOVA (Ensitrelvir) by Shionogi

The FDA has accepted the New Drug Application for XOCOVA, an antiviral drug containing Ensitrelvir.

RegulatoryJuly 20, 2026

FDA Grants Priority Review for BLA761468 (HEPCLUDEX) by Gilead Sciences

The FDA has granted priority review status for Gilead Sciences' BLA761468, known as HEPCLUDEX.

StrategyJuly 16, 2026

FDA Grants Approval for Foscarnet Sodium ANDA220068 by Caplin

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 220068 for Foscarnet Sodium submitted by Caplin.

StrategyJuly 15, 2026

FDA Submission for Tenofovir Alafenamide Fumarate by Laurus Labs

Laurus Labs has submitted an ANDA for Tenofovir Alafenamide Fumarate, currently under standard review.

StrategyJuly 12, 2026

FDA Grants Approval for Aciclovir ANDA215669 by Hetero Labs

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 215669 for aciclovir submitted by Hetero Labs.

StrategyJuly 9, 2026

Novitium Pharma's Aciclovir ANDA212252 Receives AP Status from FDA

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'AP' for Novitium Pharma's acyclovir.

StrategyJuly 9, 2026

Aurobindo Pharma's Aciclovir ANDA216331 Receives AP Status from FDA

Aurobindo Pharma's Abbreviated New Drug Application (ANDA) for Aciclovir has received an Approved Pending (AP) status from the FDA.

RegulatoryJuly 9, 2026

FDA Grants AP Status for Acyclovir ANDA212718 by Chartwell RX

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'Approved' for Acyclovir submitted by Chartwell RX.

RegulatoryJuly 9, 2026

ACTAVIS Mid Atlantic's Aciclovir ANDA074738 Receives AP Status

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status of 'Approved' for ACTAVIS MID ATLANTIC's acyclovir.

RegulatoryJuly 9, 2026

FDA Grants Approval for Acyclovir ANDA213951 by Vistapharm

The FDA has granted approval for the ANDA213951 application for Acyclovir submitted by Vistapharm LLC.

RegulatoryJuly 7, 2026

FDA Grants Emergency Use Authorization for Remdesivir in Severe COVID-19 Cases

The FDA has authorized remdesivir for emergency use in hospitalized patients with severe COVID-19.

RegulatoryJuly 7, 2026

FDA Approves Veklury as First Treatment for COVID-19

The FDA has approved Veklury (remdesivir) as the first treatment for COVID-19 in hospitalized patients.

StrategyJuly 1, 2026

Alembic's Oseltamivir Phosphate ANDA Submission Receives AP Status

Alembic's ANDA for Oseltamivir Phosphate has been granted Abbreviated Approval (AP) status by the FDA.

RegulatoryJuly 1, 2026

FDA Accepts Supplement for Aciclovir ANDA210401 by Yiling

The FDA has accepted a supplemental application for Aciclovir under ANDA210401 submitted by Yiling.

StrategyJuly 1, 2026

FDA Grants Approval for Aciclovir ANDA212173 by YILING

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 212173 for acyclovir submitted by YILING.

RegulatoryJune 30, 2026

Aurobindo Pharma's Aciclovir Supplement Application Receives Standard Review Status

Aurobindo Pharma USA has submitted a supplement application for Aciclovir (ANDA075211) which is currently under standard review by the FDA.

RegulatoryJune 23, 2026

FDA Approves Baloxavir Marboxil for ANDA217449

The FDA has approved Baloxavir Marboxil under ANDA217449 submitted by Norwich.

StrategyJune 21, 2026

FDA Approves ANDA for Valacyclovir Hydrochloride by Hetero Labs

The FDA has approved ANDA203047 for Valacyclovir Hydrochloride submitted by Hetero Labs.

Companies

Assets

Recent signals(23)

Intranasal RNA therapy shows promise against SARS-CoV-2 with dual-targeting approach

FDA Approves Supplement for VEKLURY (Remdesivir) by Gilead Sciences

FDA Approves Supplemental Application for KALETRA by AbbVie

FDA Accepts Supplemental Application for Norvir (Ritonavir) by AbbVie

FDA Warns of Serious Liver Injury Risk with Mavyret, Zepatier, and Vosevi in Advanced Liver Disease

FDA Accepts Application for XOCOVA (Ensitrelvir) by Shionogi

FDA Grants Priority Review for BLA761468 (HEPCLUDEX) by Gilead Sciences

FDA Grants Approval for Foscarnet Sodium ANDA220068 by Caplin

FDA Submission for Tenofovir Alafenamide Fumarate by Laurus Labs

FDA Grants Approval for Aciclovir ANDA215669 by Hetero Labs

Novitium Pharma's Aciclovir ANDA212252 Receives AP Status from FDA

Aurobindo Pharma's Aciclovir ANDA216331 Receives AP Status from FDA

FDA Grants AP Status for Acyclovir ANDA212718 by Chartwell RX

ACTAVIS Mid Atlantic's Aciclovir ANDA074738 Receives AP Status

FDA Grants Approval for Acyclovir ANDA213951 by Vistapharm

FDA Grants Emergency Use Authorization for Remdesivir in Severe COVID-19 Cases

FDA Approves Veklury as First Treatment for COVID-19

Alembic's Oseltamivir Phosphate ANDA Submission Receives AP Status

FDA Accepts Supplement for Aciclovir ANDA210401 by Yiling

FDA Grants Approval for Aciclovir ANDA212173 by YILING

Aurobindo Pharma's Aciclovir Supplement Application Receives Standard Review Status

FDA Approves Baloxavir Marboxil for ANDA217449

FDA Approves ANDA for Valacyclovir Hydrochloride by Hetero Labs

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