NIH says it’s moving away from animal-based models

CBER Director Vinay Prasad sidelined staff to jettison Moderna’s mRNA flu shot

In the latest episode of Vinay Prasad’s extraordinary adventures at FDA, the agency (i.e. Dr. Prasad himself) has issued a Refusal-to-File letter to an mRNA-based influenza vaccine application.

February 13, 2026

Vol.52 No.06

By Claire Marie Porter

Cancer Policy

FDA approves labeling changes to menopausal hormone therapy products

FDA has approved drug labeling changes to six menopausal hormone therapy products, also known as hormone replacement therapy.

February 13, 2026

Vol.52 No.06

By Claire Marie Porter

Cancer Policy

HHS withdraws 340B drug rebate pilot program

HHS is withdrawing the “340B Rebate Model Pilot Program” that was intended to go into effect on Jan. 1, according to a joint motion filed last week.

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

FDA approved pembrolizumab, as well as pembrolizumab and berahyaluronidase alfa-pmph in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

February 13, 2026

Vol.52 No.06

Drugs & Targets

FDA approves companion diagnostic for pembrolizumab for ovarian cancer

FDA has approved PD-L1 IHC 22C3 pharmDx, Code SK006m as the only FDA-approved companion diagnostic indicated to aid in identifying first-line patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, whose tumors express PD-L1 and who may be eligible for treatment with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy.

February 13, 2026

Vol.52 No.06

Capitol Hill

After a brief government shutdown, FY26 funding bill is signed into law
NIH gets $415M raise, NCI gets $128M more, CDMRP funding largely restored

On Feb. 3, the House of Representatives passed the Senate Amendment to H.R. 7148, the Consolidated Appropriations Act, 2026, by a vote of 217 to 214. Later that day, President Donald Trump signed the bill into law, officially ending the brief partial government shutdown that began on Jan. 31.

February 06, 2026

Vol.52 No.05

By Jacquelyn Cobb

NIH says it’s moving away from animal-based models

YOU MAY BE INTERESTED IN

CBER Director Vinay Prasad sidelined staff to jettison Moderna’s mRNA flu shot

FDA approves labeling changes to menopausal hormone therapy products

HHS withdraws 340B drug rebate pilot program

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

FDA approves companion diagnostic for pembrolizumab for ovarian cancer

After a brief government shutdown, FY26 funding bill is signed into law
NIH gets $415M raise, NCI gets $128M more, CDMRP funding largely restored

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NIH says it’s moving away from animal-based models

YOU MAY BE INTERESTED IN

CBER Director Vinay Prasad sidelined staff to jettison Moderna’s mRNA flu shot

FDA approves labeling changes to menopausal hormone therapy products

HHS withdraws 340B drug rebate pilot program

FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma

FDA approves companion diagnostic for pembrolizumab for ovarian cancer

After a brief government shutdown, FY26 funding bill is signed into lawNIH gets $415M raise, NCI gets $128M more, CDMRP funding largely restored

Never miss an issue!

Login

After a brief government shutdown, FY26 funding bill is signed into law
NIH gets $415M raise, NCI gets $128M more, CDMRP funding largely restored