FDA

Elixiron’s enrupatinib shows upbeat interim phase II AD results

Tue, 16 Jun 2026 12:00:00 -0400

Elixiron Immunotherapeutics Inc. announced positive interim open-label phase II Alzheimer’s disease (AD) study findings of enrupatinib, an oral brain-penetrant colony-stimulating factor 1 receptor inhibitor, with plans to move the asset into a biomarker-based and placebo-controlled study.

Another shot: Moderna flu vaccine re-upped in adcom

Tue, 16 Jun 2026 12:00:00 -0400

Moderna Inc. will soon find out if the tumult-ridden U.S. FDA’s switcheroo in mid-February will stick regarding mRNA-1010, a prospective new seasonal influenza vaccine. The Vaccines and Related Biological Products Advisory Committee on June 17 takes up the matter of the shot, which trails a curious history.

Elixiron’s enrupatinib shows upbeat interim phase II AD results

Mon, 15 Jun 2026 12:00:00 -0400

No CNPV needed? Sanofi’s Tzield gains accelerated nod in stage 3 T1D

Mon, 15 Jun 2026 12:00:00 -0400

Despite some back-and-forth with the U.S. FDA regarding inclusion in the somewhat controversial Commissioner’s National Priority Voucher (CNPV) program, Sanofi SA’s Tzield (teplizumab) gained FDA clearance, expanding use of the CD3-directed monoclonal antibody as a disease-modifying therapy for patients with recently diagnosed stage 3 type 1 diabetes (T1D).

Another FDA no for Camurus’ monthly acromegaly drug Oclaiz

Thu, 11 Jun 2026 12:00:00 -0400

In a repeat move, the U.S. FDA issued yet again a complete response letter (CRL) to Camurus AB for its subcutaneous extended-release injection drug CAM-2029 (octreotide) to treat the rare chronic growth disorder acromegaly. The drug, which expects to be branded Oclaiz in the U.S. upon approval, is called Oczyesa in the EU and the U.K., where it received marketing authorization in 2025.

‘Disciplined’ $665M deal moves Oscotec’s cevidoplenib to Agios

Tue, 09 Jun 2026 12:00:00 -0400

Agios Pharmaceuticals Inc.’s potential $665 million deal for Oscotec Inc.’s cevidoplenib, a phase III-ready oral SYK inhibitor to treat immune thrombocytopenia, marks a new chapter of development focused on cancer therapy resistance for Oscotec, CEO Yoon Tae-young said.

Gen1e Lifesciences receives US FDA designations for GEn-1123

Tue, 09 Jun 2026 09:00:00 -0400

Gen1e Lifesciences Inc. has obtained both orphan drug and rare pediatric disease designations from the U.S. FDA for GEn-1123 for the treatment of Duchenne muscular dystrophy (DMD).

Amphista’s BRD9 degrader gains IND clearance for AML

Mon, 08 Jun 2026 09:00:00 -0400

Amphista Therapeutics Ltd. has obtained IND clearance from the FDA for AMX-883, an orally bioavailable degrader of BRD9, for the treatment of acute myeloid leukemia (AML). A phase I trial in patients with relapsed or refractory AML and high-risk myelodysplastic syndrome is expected to begin in the second half of this year.

FDA gets earful on CNPV pilot

Fri, 05 Jun 2026 12:00:00 -0400

The U.S. FDA’s year-old Commissioner’s National Priority Voucher (CNPV) pilot program played to mixed reviews at the agency’s June 4 listening session intended to get various stakeholders’ perspective on the ultra-accelerated review process being offered to qualifying drugs.

‘Disciplined’ $665M deal moves Oscotec’s cevidoplenib to Agios

Fri, 05 Jun 2026 12:00:00 -0400

Sotio Biotech’s SOT-106 designated orphan drug for osteosarcoma

Thu, 04 Jun 2026 09:00:00 -0400

Sotio Biotech AS’s SOT-106 has been granted orphan drug designation by the FDA for the treatment of osteosarcoma. SOT-106 is a next-generation antibody-drug conjugate targeting leucine-rich repeat-containing 15 (LRRC15), a clinically validated target broadly expressed across sarcoma subtypes and in tumor-associated stroma.

Hanmi, Haisco win billion-dollar partnerships with Eli Lilly

Tue, 02 Jun 2026 12:00:00 -0400

Hanmi Pharmaceutical Co. Ltd. secured a $1.26 billion deal with Eli Lilly and Co. to out-license ex-Korea rights to sonefpeglutide (HM-15912), a Lapscovery-based glucagon-like peptide-2 analog in development for multiple indications, including an ongoing phase II study of short bowel syndrome. It was one of two billion-dollar Asian company deals signed by Lilly on June 1, with the second transaction involving Haisco Pharmaceutical Group Co. Ltd., of Beijing.

Fulcrum drops work on SCD drug pociredir; stock plummets

Tue, 02 Jun 2026 12:00:00 -0400

Shares of Fulcrum Therapeutics Inc. (NASDAQ:FULC) fell 54% after the company said it is discontinuing work on sickle cell disease (SCD) candidate pociredir, its only clinical-stage candidate, and reviewing strategic alternatives in the wake of the U.S. FDA’s safety concerns regarding the drug target.

FDA advises leveraging what’s already known in gene therapy R&D

Tue, 02 Jun 2026 12:00:00 -0400

Rather than reinventing the wheel for every gene therapy that uses genome editing, the U.S. FDA is advising sponsors on leveraging existing knowledge, be it publicly available or platform-based, to more efficiently advance their products across multiple stages of development.

FDA approves IND for Iovance’s TIL therapy IOV-5001

Tue, 02 Jun 2026 09:00:00 -0400

Iovance Biotherapeutics Inc. has received IND clearance from the FDA for IOV-5001, a next-generation interleukin-12 (IL-12)-tethered tumor-infiltrating lymphocyte (TIL) therapy.

Voyager’s tau-targeted gene therapy VY-1706 gains IND approval

Tue, 02 Jun 2026 09:00:00 -0400

Voyager Therapeutics Inc. has obtained IND clearance from the FDA for VY-1706, the company’s investigational gene therapy for the treatment of Alzheimer’s disease.

FDA clears Shionogi’s Xocova as first COVID-19 prevention pill

Tue, 02 Jun 2026 08:00:00 -0400

The U.S. FDA approved Shionogi & Co. Ltd.’s Xocova (ensitrelvir) as the first oral post-exposure prophylactic option in the U.S. to prevent COVID-19, with the decision coming ahead of a PDUFA target date of June 16.

Hanmi, Haisco win billion-dollar partnerships with Eli Lilly

Mon, 01 Jun 2026 12:00:00 -0400

Replimune tries again with melanoma drug post FDA shakeup

Fri, 29 May 2026 12:00:00 -0400

Industry watchers will be tracking closely Replimune Group Inc.’s latest attempt to secure U.S. FDA approval of its advanced melanoma candidate, RP-1 (vusolimogene oderparepvec). The company announced Friday it had reached alignment for resubmitting the twice-rejected BLA with the agency, which it said has pledged to prioritize the review.

FDA accepts IND for Rest Therapeutics’ early PTSD candidate

Fri, 29 May 2026 09:00:00 -0400

The FDA has accepted the IND application from Rest Therapeutics SAS for RST-101, the company’s lead investigational candidate for the early treatment of post-traumatic stress disorder (PTSD).

TROP2 ADCs progress into first-line for lung, breast cancers

Thu, 28 May 2026 12:00:00 -0400

Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics.

TROP2 ADCs progress into first-line for lung, breast cancers

Thu, 28 May 2026 12:00:00 -0400

FDA’s VRBPAC faces complex COVID-19 landscape

Thu, 28 May 2026 12:00:00 -0400

Landing on the right COVID-19 vaccine formulation for the coming season is becoming more complicated against a backdrop of low vaccination rates, young children with little to no immunization, declining surveillance data and a new SARS-COV-2 lineage slowly emerging.

Elzonris this: FDA clears Abbvie’s Decnupaz in BPDCN

Thu, 28 May 2026 12:00:00 -0400

Payoff for the November 2023 buyout of Immunogen Inc. came for Abbvie Inc. in the form of U.S. FDA clearance for the CD123-targeting antibody-drug conjugate Decnupaz (pivekimab sunirine) to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare, aggressive and quick-killing hematologic malignancy.

Newcelx submits pre-IND package for NCEL-101 to FDA

Wed, 27 May 2026 09:00:00 -0400

Newcelx Ltd. has submitted a pre-IND briefing package to the U.S. FDA to support a proposed first-in-human trial of NCEL-101 in combination with tegoprubart, an investigational anti-CD40L monoclonal antibody being developed by Eledon Pharmaceuticals Inc.

FDA adcom to consider next iteration of COVID-19 vaccines

Tue, 26 May 2026 12:00:00 -0400

What would normally be a routine meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee May 28 may be more carefully watched given the overall turmoil surrounding vaccines in the U.S. The only task before the adcom is to recommend the COVID-19 vaccine formula for the upcoming season. That conversation will include looking at the effectiveness of the four FDA-approved vaccines currently in use in the U.S.

Lilly’s oral GLP-1 milestone highlights a steady April for FDA approvals

Fri, 22 May 2026 12:00:00 -0400

The U.S. FDA granted 14 approvals in April 2026, down from March’s 19 but broadly in line with the historical range for the month.

FDA clears Qihan Biotech’s CAR T therapy QT-019C for clinic

Thu, 21 May 2026 09:00:00 -0400

Hangzhou Qihan Biotech Co. Ltd. has obtained IND clearance from the FDA for QT-019C, a universal allogeneic CAR T-cell therapy for autoimmune diseases. QT-019C cell injection is an off-the-shelf allogeneic CAR T-cell therapy engineered from healthy donor leukapheresis products to stably express two distinct CARs targeting CD19 and BCMA.

FDA approval advances personalized cancer diagnostics

Wed, 20 May 2026 12:00:00 -0400

The evolution of cancer diagnostics continues with the FDA’s May 20 approval of Guardant Health Inc.’s Guardant360 Liquid cDx. The new blood-based comprehensive genomic test assesses a 100-times wider genomic footprint than the previously approved Guardant360 cDx to deliver comprehensive tumor profiling results, according to the company. It noted that the seven companion diagnostic indications already approved for the older test will transfer to the new one.

Mekanistic’s PI3K/EGFR inhibitor MTX-531 gains IND clearance

Wed, 20 May 2026 09:00:00 -0400

Mekanistic Therapeutics Inc. has obtained IND clearance from the FDA for MTX-531, the company’s lead oncology candidate. A phase I study will be conducted in patients with advanced solid tumors characterized by dysregulated EGFR and/or PI3K signaling, including head and neck and endometrial cancers. Dosing is expected to begin in the third quarter.