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As part of its third-quarter report, Roche announced it has cut two Phase II programs, one for hepatitis B and the other for geographic atrophy, a form of eye disease.
Mereo BioPharma will cut 40% of its headcount and significantly reduce expenses to support the advancement of its lead programs through the clinic.
Between top-notch academic institutions, solid venture capital funding, expanding lab space and governmental support, Chicago is emerging as a true hotbed for biotech growth.
An analysis of un-blinded interim data showed fosgonimeton provided clinically meaningful improvements in cognition and function in patients with mild-to-moderate Alzheimer’s disease.
Shares of Massachusetts-based Minerva Neurosciences dropped Monday after the FDA issued a Refuse to File letter for the company’s schizophrenia drug, roluperidone.
Biogen announced the FDA has extended its review for ALS drug tofersen by three months. The regulator set a new PDUFA action date set of April 25, 2023.
Milestone Pharmaceuticals reported highly positive data from its Phase III RAPID trial of etripamil in paroxysmal supraventricular tachycardia (PSVT) patients.
Sage Therapeutics and Biogen’s zuranolone met its primary and key secondary endpoints in the Phase III SKYLARK study of women with postpartum depression (PPD).
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Kineta struck a collaboration deal with Merck to pair its anti-VISTA monoclonal antibody with Keytruda (pembrolizumab) as a potential treatment for advanced solid tumors.
Gilead Sciences and MacroGenics entered into a licensing and collaboration pact worth up to $1.7 billion to develop a bispecific antibody to treat hematological cancers.
NeuBase announced a strategic restructuring, diverting resources from its Huntington’s program and shedding 60% of its workforce.
SURGE Therapeutics announced $26 million in Series A financing to address surgery-induced immune suppression and prevent post-surgical cancer recurrence and metastasis.
With military precision and academic ingenuity, Israel is building a thriving biotech ecosystem. Venture capitalists would do well to pay attention.
After suffering a blow to its multi-billion dollar liver cancer program, BridgeBio presented early but promising data in ultra-rare Canavan disease.
France-based biotech Mablink secured $30 million (€31 million EUR) to develop next-generation antibody-drug conjugates for the treatment of cancer.
Novartis, GlaxoSmithKline and Sanofi have announced plans for significant cutbacks and changes in their labor force overseas for financial, operational and logistical reasons.
Enliven Therapeutics and Imara will merge in an all-stock deal to form a precision oncology company. The new entity will operate under the name Enliven Therapeutics.
Matchpoint Therapeutics hit the ground running Friday with $100 million in investments and a focus on developing precision small molecule medicines.
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.