AllSci News
Veradermics' oral minoxidil meets endpoints in Phase II/III male pattern hair loss trial
Veradermics (NYSE: MANE) reported that its extended-release oral minoxidil tablet, VDPHL01, met all primary and key secondary endpoints in a Phase II/III...
Terns’ BCR::ABL1 inhibitor earns FDA Breakthrough Therapy status for CML
Terns Pharmaceuticals (Nasdaq: TERN), headquartered in Foster City, California, announced that the US FDA granted Breakthrough Therapy Designation (BTD) to TERN-701, an…
Jazz Pharma’s bispecific antibody zanidatamab receives FDA Priority Review for HER2+ gastric cancer
Jazz Pharmaceuticals plc (Nasdaq: JAZZ), headquartered in Dublin, announced that the US FDA has accepted for filing with Priority Review a supplemental…
Eli Lilly acquires Ajax Therapeutics for USD 2.3b targeting myeloproliferative neoplasm treatments
Eli Lilly (NYSE: LLY) has agreed to acquire US-based Ajax Therapeutics, a private New York-incorporated biopharmaceutical company, for up to USD 2.3 billion...
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...
CHMP gives nod for Arrowhead’s Redemplo in familial chylomicronemia syndrome
Arrowhead Pharmaceuticals has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending authorization…
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...
Sun Pharma acquires Organon for USD 11.75b, expanding Women's Health and biosimilars portfolio
India-based Sun Pharmaceutical Industries Limited (Reuters: SUN.BO | NSE: SUNPHARMA | BSE: 524715) has entered into a definitive agreement to acquire...
Kyowa Kirin, Kura initiate Japanese Phase II for ziftomenib in relapsed/refractory NPM1-mutated AML
Kyowa Kirin and Kura Oncology have initiated a Japanese Phase II registration-directed trial of ziftomenib in adult patients with relapsed/refractory...
Insilico Medicine nominates ISM0387 as preclinical candidate from generative AI platform in United Arab Emirates
Insilico Medicine announced the nomination of ISM0387 as a preclinical candidate in the United Arab Emirates, marking what the company described as the...
AbbVie’s Rinvoq secures EMA Orphan Drug Designation for systemic sclerosis
AbbVie’s upadacitinib received orphan drug designation from the European Medicines Agency (EMA) for the treatment of systemic sclerosis on 20 April 2026,…
Grace Therapeutics receives CRL from US FDA for GTx-104 nimodipine formulation
Grace Therapeutics, Inc. disclosed that the US FDA issued a Complete Response Letter (CRL) for the company’s New Drug Application (NDA) for…
FDA approves Regeneron’s Otarmeni as first gene therapy for genetic hearing loss
The US FDA has approved Otarmeni (lunsotogene parvec-cwha), the first gene therapy for genetic hearing loss, granting Regeneron Pharmaceuticals accelerated approval for…
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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