NEWS

Corcept Receives US FDA Complete Response Letter for Relacorilant in Hypercortisolism

Shots: The US FDA has issued a Complete Response Letter (CRL) to Corcept for the NDA of relacorilant for the treatment of hypertension secondary to hypercortisolism While the US FDA acknowledged that the pivotal P-III (GRACE) study met its 1EP and that data from the GRADIENT study provided supportive evidence, the Agency concluded that additional…

January 2, 2026

Samsung Bioepis Began Direct Commercialization of Byooviz (Biosimilar, Lucentis) Across Europe

Shots: Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26 Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due…

January 2, 2026

Delcath Systems Publishes Subgroup Analyses of The P-III Study on Unresectable Metastatic Uveal Melanoma Patients

Shost: Delcath Systems has reported the publication of subgroup analyses from the Phase 3 (FOCUS) study in the Journal of Cancer Research and Clinical Oncology, evaluating the efficacy and safety of the HEPZATO KIT on melphalan/hepatic delivery in pts with unresectable metastatic uveal melanoma In the subgroup analyses (n=91) of the P-III (FOCUS) Study pts,…

January 2, 2026

Intelligent Bio Solutions and Syrma Johari MedTech Collaborate to Advance Global Production Capability and Margin Expansion

Shots: Intelligent Bio Solutions has entered into a strategic manufacturing partnership with Syrma Johari MedTech to scale production of its Intelligent Fingerprinting Drug Screening Reader and support long-term margin improvement Under the agreement, the partnership advances INBS’ global manufacturing strategy by diversifying suppliers, strengthening supply chain resilience, expanding capacity, and increasing flexibility ahead of anticipated multi-region…

January 2, 2026

Outlook Therapeutics Shares Update on FDA Review of ONS-5010/Lytenava for Wet AMD

Shots: The FDA issued a complete response letter for the ONS-5010/LYTENAVA™ BLA resubmission, declining approval for wet AMD in its current form The ONS-5010 BLA resubmission was based on full NORSE trial data, including the pivotal NORSE TWO and confirmatory studies like NORSE EIGHT, a study evaluating ONS-5010 vs ranibizumab in a 12-wk trial of…

January 1, 2026

Mabwell’s Adalimumab Injection (Biosimilar, Humira) Granted Marketing Approval in Indonesia

Shots: Mabwell’s Adalimumab Injection 9MW0113 (marketed as JUNMAIKANG in China), a Humira biosimilar, has received marketing authorization from Indonesia’s BPOM Adalimumab Injection 9MW0113, co-developed by Mabwell and Junshi Biosciences. Mabwell has submitted registration applications in multiple countries, including Jordan and Peru, and has agreements in over ten markets Adalimumab is a TNF blocker, binds TNF‑alpha…

January 1, 2026

Axsome Therapeutics Reports the US FDA’s sNDA Acceptance with Priority Review of AXS-05 for the Treatment of Alzheimer’s Disease Agitation

Shots: The US FDA has accepted sNDA & granted priority review to AXS-05 (dextromethorphan HBr and bupropion HCl) to treat Alzheimer’s disease agitation (PDUFA: April 30, 2026) The sNDA reflects AXS-05’s clinical development program in Alzheimer’s disease agitation, which included four randomized, double-blind P-III trials and a long-term safety study AXS-05 is an oral investigational…

January 1, 2026

Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis

Shots: The USDA has granted Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis, expected to launch in H1’26 Befrena (mAb) is an anti-IL31 injection for dogs, treats allergic and atopic dermatitis every 6–8 wks. In September, the FDA approved changes to Zenrelia (ilunocitinib tablets) US label, eliminating the fatal vaccine-induced disease risk, Elanco announced Ref:…

January 1, 2026

FibroBiologics Submits IND Application with the US FDA for CYPS317 in Patients with Psoriasis

Shots: The company has filed a P-I/II IND with the FDA to begin clinical trials of CYPS317 for mod. to sev. Psoriasis In animal studies, a single dose of CYPS317 matched or exceeded multiple anti-IL-23 mAb doses, showing durable effects and reduced disease recurrence CYPS317 is an investigational allogeneic fibroblast spheroid therapy for mod. to…

January 1, 2026

CapsoVision Reports US FDA 510(k) Submission for AI-Assisted Reading Module in CapsoCam Plus

Shots: The company has submitted a 510(k) application to the US FDA for its proprietary AI-assisted module designed for use with CapsoCam Plus The CapsoCam Plus capsule endoscopy system is designed to visualize small bowel mucosa and detect abnormalities in adults and children (age ≥ 2 yrs) The reading tool is expected to improve the…

January 1, 2026

NEWS

Corcept Receives US FDA Complete Response Letter for Relacorilant in Hypercortisolism

Samsung Bioepis Began Direct Commercialization of Byooviz (Biosimilar, Lucentis) Across Europe

Delcath Systems Publishes Subgroup Analyses of The P-III Study on Unresectable Metastatic Uveal Melanoma Patients

Intelligent Bio Solutions and Syrma Johari MedTech Collaborate to Advance Global Production Capability and Margin Expansion

Outlook Therapeutics Shares Update on FDA Review of ONS-5010/Lytenava for Wet AMD

Mabwell’s Adalimumab Injection (Biosimilar, Humira) Granted Marketing Approval in Indonesia

Axsome Therapeutics Reports the US FDA’s sNDA Acceptance with Priority Review of AXS-05 for the Treatment of Alzheimer’s Disease Agitation

Elanco Animal Health Reports the USDA Approval of Befrena (Tirnovetmab) for Canine Allergic and Atopic Dermatitis

FibroBiologics Submits IND Application with the US FDA for CYPS317 in Patients with Psoriasis

CapsoVision Reports US FDA 510(k) Submission for AI-Assisted Reading Module in CapsoCam Plus

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