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Approval · news · pharmadog
← back to Approval
News · Approval
648
stories
22d
Opinion: U.S. dependence on China is a national security risk
stat
22d
Biogen validated the Alzheimer’s tau theory. CEO Viehbacher still isn’t betting the store
biospace
23d
Recon: FDA adcomm votes against Capricor’s DMD drug; Cytokinetics gets UK approval, NICE backing for heart drug
raps
23d
Euro Roundup: EFPIA pushes for shorter trial approval times in EU Biotech Act
raps
23d
Researchers concerned by underutilization of accelerated approval in oncology
raps
23d
FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
biospace
23d
FDA reviewers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting
biospace
23d
Capricor Duchenne cell therapy voted down by FDA panel
biopharma dive
23d
MapLight CEO on what investors missed in the biotech’s schizophrenia data
biopharma dive
23d
Updated: FDA adcomm votes down Capricor's DMD therapy over efficacy
endpoints
23d
FDA adcomm shoots down Capricor's Duchenne cell therapy after meeting marked by statistical dispute
fiercebiotech
23d
Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology push
biopharma dive
23d
FDA reviewers criticize Replimune drug; ProMIS climbs on Alzheimer’s data
biopharma dive
23d
Kyverna taps ElevateBio to secure commercial supply of autoimmune CAR-T therapy
biospace
23d
STAT+: Why benchmarking clinical LLMs from OpenEvidence, Doximity is complicated
stat
23d
Incyte cuts early-stage cancer drug to focus on next-gen programs
biospace
23d
Novo ordered to face CagriSema fraud claims from shareholders: New Jersey court
biospace
23d
Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
biospace
23d
Processa acquires Vidya for potential BTK inhibitor rival to Novartis’ Rhapsido
fiercebiotech
23d
STAT+: FDA expert panel recommends against approval of Capricor’s Duchenne drug
stat
23d
Biotechs bring big launches and pharma rivalries into Q2 earnings period
biospace
24d
FDA reminds investors about the risks of advisory panels
endpoints
24d
FDA offers updated guidance for generics of weight loss blockbusters
endpoints
24d
Visa time limits on foreign Ph.D. students and postdocs will harm U.S. science, experts warn
stat
24d
GSK prepares for patent cliff with $2.5B cost-cutting plan
biopharma dive
24d
FDA staff say Replimune's melanoma trial failed to prove RP1 works
endpoints
24d
GSK shares rise as $2.5B cost-cutting plan unveiled
biospace
24d
The future of gray-market peptides
endpoints
24d
STAT+: FDA staff reiterate concerns about Replimune skin cancer treatment
stat
24d
FDA says Replimune’s melanoma data package is ‘not interpretable,’ setting up tough adcomm
biospace
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