Regulatory & Policy
FDA aligns with Pierre Fabre on Ebvallo resubmission path for EBV+ PTLD treatment
Pierre Fabre Pharmaceuticals has announced it has aligned with the US FDA on a potential path forward for resubmission of the Biologics License Application...
Insilico's rentosertib inhalation solution receives China IND clearance for IPF
Insilico Medicine (HKEX: 3696) announced that China's Center for Drug Evaluation (CDE) has cleared an investigational new drug (IND) application for an...
FDA approves Guardant360 CDx companion diagnostic for Arvinas and Pfizer's Veppanu in advanced breast cancer
The US FDA has approved Guardant360 CDx as a companion diagnostic for Veppanu (vepdegestrant), the PROTAC estrogen receptor degrader jointly developed by...
Clene planning NDA filing for CNM-Au8 gold nanocrystal suspension for ALS
Clene Inc. announced plans to file a New Drug Application (NDA) with the US FDA for CNM-Au8, an oral suspension of gold nanocrystals, seeking accelerated...
IDEAYA Biosciences initiates FDA submission for darovasertib plus crizotinib in metastatic uveal melanoma
IDEAYA Biosciences has initiated a New Drug Application (NDA) submission to the US FDA for darovasertib in combination with crizotinib, seeking approval in...
FDA advisory committee votes against AstraZeneca's camizestrant combination for hormone receptor-positive advanced breast cancer
AstraZeneca's New Drug Application for camizestrant in combination with a CDK4/6 inhibitor encountered a setback on May 1, 2026, when the US FDA's Oncologic...
FDA advisory committee recommends AstraZeneca's Truqap for PTEN-deficient prostate cancer
AstraZeneca's Truqap (capivasertib) received a positive recommendation from the US FDA's Oncologic Drugs Advisory Committee (ODAC) for use in patients with...
FDA grants priority review to Jazz Pharmaceuticals' Ziihera for first-line HER2-positive gastric cancer
Jazz Pharmaceuticals submitted a supplemental Biologics License Application (sBLA) to the US FDA for Ziihera (zanidatamab-hrii) in combination regimens for...
Organogenesis completes BLA submission for Renu for symptomatic knee osteoarthritis management
Organogenesis completed a rolling Biologics License Application (BLA) submission to the US FDA for Renu (cryopreserved amniotic suspension allograft),...
AbbVie submits application for Skyrizi subcutaneous induction in Crohn's disease
AbbVie submitted a supplemental Biologics License Application (sBLA) to the US FDA seeking approval for Skyrizi (risankizumab-rzaa) as a subcutaneous...
Novartis withdraws EMA application to expand Pluvicto into earlier prostate cancer setting
Novartis Withdraws EMA Application to Expand Pluvicto into Earlier Prostate Cancer Setting
Intellia starts FDA submission for in vivo Crispr therapy lonvo-z as one-time angioedema treatment
Intellia Therapeutics has initiated a rolling submission of a Biologics License Application (BLA) to the US FDA for Lonvoguran ziclumeran (lonvoguran...
FDA points way forward for Compass Pathways' psilocybin in treatment-resistant depression
Compass Pathways has submitted a rolling New Drug Application (NDA) to the US FDA for COMP360 (synthetic psilocybin), seeking approval in patients with...
FDA issues Complete Response Letter for AbbVie's Trenibote for glabellar lines
AbbVie's Biologics License Application for Trenibote (trenibotulinumtoxinE) has encountered a regulatory setback after the US FDA issued a Complete Response...
Mabwell's global first-in-class LILRB4/CD3 bispecific reaches IND stage in China for AML
Mabwell (688062.SH) announced on April 15, 2026 that China's National Medical Products Administration has accepted an investigational new drug application...
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