Regulatory & Policy
Revolution lands first approval for RAS(ON) platform with Rasonque
The US FDA has approved Rasonque (daraxonrasib), the first-in-class pan-RAS inhibitor developed by Revolution Medicines (Nasdaq: RVMD), for adults with...
Celcuity seeks to expand Revtorpyk label to PIK3CA-mutant breast cancer after beating alpelisib
Minneapolis-based Celcuity Inc. (Nasdaq: CELC) submitted a supplemental New Drug Application (sNDA) to the US FDA for Revtorpyk (gedatolisib), seeking...
Cellenkos's Treg cell therapy CK0803 wins FDA fast track for ALS
Houston-based Cellenkos, Inc. announced receipt of US FDA Fast Track Designation for CK0803, an allogeneic cord blood-derived T-regulatory (Treg) cell...
EC approves Acadia's Daybu as first-ever Rett syndrome treatment in the EU
The European Commission has granted marketing authorization for Daybu (trofinetide), making San Diego-based Acadia Pharmaceuticals (Nasdaq: ACAD) the first...
CSPC's PD-1/IL-15 fusion protein earns FDA Fast Track status for MSS/pMMR CRC
China-based CSPC Pharmaceutical Group Limited (HKEX: 01093) announced receipt of US FDA Fast Track Designation for SYS6090 (JMT108), a first-in-class...
Takeda adds Japan approval for narcolepsy treatment Orzeyful
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1) in adults, marking a...
Trodelvy stakes out broader first-line TNBC role with EU combo approval
The European Commission has approved Trodelvy (sacituzumab govitecan) in combination with pembrolizumab for adult patients with unresectable locally...
Viiv's dolutegravir nodded by FDA for HIV treatment in newborns
The US FDA has approved Tivicay PD (dolutegravir) tablets for oral suspension to treat HIV infection in newborns from birth up to four weeks of age weighing...
Ziihera moves into first-line HER2+ gastroesophageal cancer with FDA approval
The US FDA has approved two regimens containing Ziihera (zanidatamab-hrii) for the first-line treatment of adults with unresectable locally advanced or...
EMA rejects arimoclomol for Niemann-Pick disease type C over efficacy concerns
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on July 23, 2026, recommending refusal of...
Japan approves Brinsupri as first treatment for non-cystic fibrosis bronchiectasis
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Brinsupri (brensocatib) for non-cystic fibrosis bronchiectasis (NCFB) in adults and...
Rhythm's Imcivree becomes first approved therapy for acquired hypothalamic obesity in Japan
Japan's Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorization to Imcivree (setmelanotide) for acquired hypothalamic obesity...
FDA puts GSK’s Jemperli on priority review in locally advanced rectal cancer
The US FDA has accepted for priority review a supplemental Biologics License Application (sBLA) for dostarlimab (Jemperli), GSK's (LSE/NYSE: GSK)...
Japan approves GSK's Hibsago as first functional cure for chronic hepatitis B
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Hibsago (bepirovirsen) for chronic hepatitis B (CHB) in adults who have received at least...
FDA approves Imaavy as first treatment specifically indicated for wAIHA
The US FDA has approved Imaavy (nipocalimab-aahu) as the first therapy specifically indicated for warm autoimmune hemolytic anemia (wAIHA). Johnson &...
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