Regulatory & Policy
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...
China Medical System submits NDA in China for IL-4Ralpha mAb comekibart in seasonal allergic rhinitis
China Medical System submits NDA for long-acting IL-4Rα antibody in seasonal allergic rhinitis
Belite Bio initiates NDA submission for tinlarebant in Stargardt disease type 1
Belite Bio has initiated a rolling New Drug Application (NDA) submission to the US FDA for tinlarebant (LBS-008), an oral investigational therapy targeting...
FDA accepts Dogwood Therapeutics' SP16 IND application for chemotherapy-induced pain and neuropathy
Dogwood Therapeutics announced that the US FDA has accepted an Investigational New Drug (IND) application for SP16, an intravenously administered...
Renaissance Pharma's daretabart receives FDA Fast Track designation for high-risk neuroblastoma
Renaissance Pharma Limited announced in April 2026 that the US FDA had granted Fast Track Designation for daretabart (hu1418K322A) and cleared the company's...
FDA delays review of Savara's molgramostim inhalation solution for autoimmune PAP to November
The US FDA has extended its review period for the Biologics License Application (BLA) submitted by Savara Inc. for molgramostim inhalation solution...
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