Gilead’s Bixlenvo Secures US FDA Approval for Virologically Suppressed Adults With HIV

Shots: The US FDA has approved Bixlenvo (bictegravir 75mg/lenacapavir 50mg) for the treatment of HIV in adults who are virologically suppressed Approval was based on the P-III (ARTISTRY-1 & ARTISTRY-2) trials, assessing Bixlenvo (QD, PO) in adults with HIV who are virologically suppressed, incl. those who switched from complex multi-tablet regimens or from Biktarvy In…

ByRidhi RastogiAugust 31, 2026

NEWS

Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

Shots: The US FDA has approved Trodelvy + Keytruda/Keytruda Qlex for the 1L treatment of adults with inoperable, locally advanced, or metastatic TNBC expressing PD-L1 (CPS ≥ 10) Approval was based on the P-III (ASCENT-04/KEYNOTE-D19) trial assessing Trodelvy (10mg/kg, IV, Day 1 & 8 of each 21-day cycle) + Keytruda (200mg, IV, Day 1 of…

ByRidhi RastogiJune 25, 2026

NEWS

Gilead’s Trodelvy Receives the EC Approval for 1L Metastatic TNBC Patients Ineligible for PD-1/PD-L1 Inhibitor Therapy

Shots: The EC has approved Trodelvy monotx. as a 1L therapy for the treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy across all 30 EEA states Approval was backed by the P-III (ASCENT-03) trial showing a 38% reduced risk of disease progression or death in patients who are…

ByRidhi RastogiJune 24, 2026

NEWS

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

Shots: The US FDA has accepted sNDA of Yeztugo (300mg, QW, PO) as a pre-exposure prophylaxis therapy for the prevention of HIV (PDUFA: Feb 02, 2027) sNDA was supported by the P-III (PURPOSE 1 & PURPOSE 2) trials of Yeztugo, which demonstrated high efficacy across diverse global populations, incl. cisgender women, cisgender men & gender-diverse…

ByRidhi RastogiJune 16, 2026

INSIGHTS+

The US FDA New Drug Approvals in May 2026

Shots: The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases. Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP). Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…

ByDipanshu DixitJune 9, 2026

NEWS

Gilead Reports the P-III (IDEAL) Trial Data on Livdelzi (Seladelpar) in Primary Biliary Cholangitis (PBC)

Shots: Gilead has reported the P-III (IDEAL) trial data assessing Livdelzi (seladelpar) vs PBO in 96 adults (18-75yrs.) with PBC who have inadequately controlled disease, on or intolerant to ursodeoxycholic acid Trial showed that a higher proportion of pts treated with Livdelzi achieved normalization of ALP after 52wks.; data to be presented at a future conference & discussed…

ByRidhi RastogiJune 3, 2026

NEWS

Gilead Reports the US FDA Accelerated Approval of Hepcludex to Treat Chronic Hepatitis Delta Virus (HDV) Infection

Shots: The US FDA has granted accelerated approval for Gilead’s Hepcludex (bulevirtide-gmod; 8.5mg) for the treatment of adults with chronic HDV infection Approval was based on the P-III (MYR301) trial assessing Hepcludex (QD, SC) for 144wks. in pts living with HDV, followed by 96wks. of off-treatment follow-up Trial showed significant improvements in HDV RNA reduction & ALT…

ByRidhi RastogiMay 25, 2026

NEWS

Gilead to Acquire Tubulis for ~$5B

Shots: Gilead has entered into a definitive agreement to acquire Tubulis, making it an ADC research organization within Gilead, with the Munich site serving as a hub for ADC innovation As per the deal, Gilead will acquire Tubulis for $3.15B upfront & ~$1.85B in contingent milestone payments; closing is expected in Q2’26 Acquisition will expand…

ByRidhi RastogiApril 8, 2026

NEWS

Gilead to Acquire Ouro Medicine for ~$2.1B

Shots: Gilead to acquire Ouro for a total of $1,675M in upfront cash & up to $500M in contingent milestone payments. Acquisition will add Ouro’s P-I/II asset OM336 (gamgertamig) to Gilead’s inflammation portfolio, with registrational studies to begin in 2027 Also, Gilead is in advanced discussions with Galapagos for a potential R&D collaboration on the…

ByRidhi RastogiMarch 24, 2026

NEWS

Gilead Sciences to Acquire Arcellx for $7.8B

Shots: Gilead Sciences has entered into a definitive agreement to acquire Arcellx, incl. anito-cel from their 2022 collaboration & Arcellx’s D-Domain CAR technology platform, for the implied equity value of $7.8B As per the deal, Gilead, which owns ~11.5% of Arcellx, will launch a tender offer for $115/share, plus a non-transferable CVR of $5/CVR tied…

ByRidhi RastogiFebruary 23, 2026

Gilead’s Bixlenvo Secures US FDA Approval for Virologically Suppressed Adults With HIV

Merck and Gilead Report FDA Approval of Trodelvy + Keytruda for Previously Untreated PD-L1+ TNBC

Gilead’s Trodelvy Receives the EC Approval for 1L Metastatic TNBC Patients Ineligible for PD-1/PD-L1 Inhibitor Therapy

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

The US FDA New Drug Approvals in May 2026

Gilead Reports the P-III (IDEAL) Trial Data on Livdelzi (Seladelpar) in Primary Biliary Cholangitis (PBC)

Gilead Reports the US FDA Accelerated Approval of Hepcludex to Treat Chronic Hepatitis Delta Virus (HDV) Infection

Gilead to Acquire Tubulis for ~$5B

Gilead to Acquire Ouro Medicine for ~$2.1B

Gilead Sciences to Acquire Arcellx for $7.8B

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