📁 All Events (14395 stories)
Regenxbio's gene therapy for Duchenne muscular dystrophy successfully met its primary endpoint in a pivotal trial. This positive outcome marks a significant win for the company, which has faced recent challenges including an FDA rejection and clinical hold.
Regenxbio's gene therapy for Duchenne muscular dystrophy successfully met its primary endpoint in a pivotal trial. This positive outcome marks a significant win for the company, which has faced recent challenges including an FDA rejection and clinical hold.
Four cancer drugs received FDA approval in May. These approvals cover both haematological and solid tumour indications.
Four cancer drugs received FDA approval in May. These approvals cover both haematological and solid tumour indications.
BeOne has received FDA approval for the treatment of lymphoma. This marks a significant regulatory milestone for the drug.
BeOne has received FDA approval for the treatment of lymphoma. This marks a significant regulatory milestone for the drug.
AstraZeneca reported positive Phase 3 results for its drug Imfinzi, used alongside Padcev, in bladder cancer patients who were cisplatin-ineligible. This follows a prior FDA approval for Imfinzi in muscle-invasive bladder cancer patients eligible for cisplatin-based chemotherapy.
AstraZeneca reported positive Phase 3 results for its drug Imfinzi, used alongside Padcev, in bladder cancer patients who were cisplatin-ineligible. This follows a prior FDA approval for Imfinzi in muscle-invasive bladder cancer patients eligible for cisplatin-based chemotherapy.
BeOne Medicines received US accelerated FDA approval for its next-gen BCL2 inhibitor, sonrotoclax. The drug is approved for a rare and aggressive form of blood cancer, where it will compete with Venclexta.
BeOne Medicines received US accelerated FDA approval for its next-gen BCL2 inhibitor, sonrotoclax. The drug is approved for a rare and aggressive form of blood cancer, where it will compete with Venclexta.
On May 13, 2026, the FDA granted accelerated approval to sonrotoclax (Beqalzi), a BCL-2 inhibitor from BeOne Medicines USA, Inc. This approval is for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy.
On May 13, 2026, the FDA granted accelerated approval to sonrotoclax (Beqalzi), a BCL-2 inhibitor from BeOne Medicines USA, Inc. This approval is for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy.
The article highlights the impact of TIL therapies on cancer research, noting that the first TIL therapy received FDA approval two years ago. It prompts an inquiry into the current state of the field following this significant regulatory milestone.
The article highlights the impact of TIL therapies on cancer research, noting that the first TIL therapy received FDA approval two years ago. It prompts an inquiry into the current state of the field following this significant regulatory milestone.
Lupin Limited announced on May 13, 2026, that it received approval from the United States Food and Drug Administration (FDA) for its Famotidine Injection, USP. This approval marks a significant regulatory milestone for the global pharmaceutical leader.
Lupin Limited announced on May 13, 2026, that it received approval from the United States Food and Drug Administration (FDA) for its Famotidine Injection, USP. This approval marks a significant regulatory milestone for the global pharmaceutical leader.
On May 13, 2026, the FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax. This approval is for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or those with comorbidities.
On May 13, 2026, the FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax. This approval is for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or those with comorbidities.
Alkermes announced that its sodium oxybate drug, Lumryz, met all primary and key secondary endpoints in a Phase 3 study for a rare sleep disorder. This clinical success follows Alkermes' $2.37 billion acquisition of Avadel.
Alkermes announced that its sodium oxybate drug, Lumryz, met all primary and key secondary endpoints in a Phase 3 study for a rare sleep disorder. This clinical success follows Alkermes' $2.37 billion acquisition of Avadel.
This article describes a compilation of New Molecular Entity (NME) drug and new biologic approvals by the Center for Drug Evaluation and Research (CDER). The dataset covers approvals from 1985 to 2019, including both small molecule drugs and new biological products.
This article describes a compilation of New Molecular Entity (NME) drug and new biologic approvals by the Center for Drug Evaluation and Research (CDER). The dataset covers approvals from 1985 to 2019, including both small molecule drugs and new biological products.
Partner Therapeutics has secured FDA approval for Bizengri. The drug is indicated for adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring an NRG1 gene fusion who have progressed on or after prior systemic therapy.
Partner Therapeutics has secured FDA approval for Bizengri. The drug is indicated for adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring an NRG1 gene fusion who have progressed on or after prior systemic therapy.
ProBio Inc. and Curocell have achieved a significant milestone with the BLA regulatory approval of Anbal-cel (CRC01), a next-generation anti-CD19 CAR-T therapy. This approval highlights Korean innovation and marks commercial readiness for the drug.
ProBio Inc. and Curocell have achieved a significant milestone with the BLA regulatory approval of Anbal-cel (CRC01), a next-generation anti-CD19 CAR-T therapy. This approval highlights Korean innovation and marks commercial readiness for the drug.
Gossamer Bio, Inc. (GOSS) announced the failure of its Phase 3 PROSERA trial, resulting in an 80% drop in its stock price. Consequently, a securities class action lawsuit has been filed against the company and an executive by Hagens Berman, representing investors who purchased securities between June 16, 2025, and February 20, 2026.
Gossamer Bio, Inc. (GOSS) announced the failure of its Phase 3 PROSERA trial, resulting in an 80% drop in its stock price. Consequently, a securities class action lawsuit has been filed against the company and an executive by Hagens Berman, representing investors who purchased securities between Jun
The first PROTAC drug has gained FDA approval. This milestone bolsters the ambitions for targeted protein degradation and induced proximity in drug development.
The first PROTAC drug has gained FDA approval. This milestone bolsters the ambitions for targeted protein degradation and induced proximity in drug development.
The FDA has granted approval for Bizengri (zenocutuzumab-zbco), a drug designed to treat NRG1 fusion-positive cholangiocarcinoma, an ultra-rare and aggressive cancer. This approval represents the seventh under the National Priority Voucher Pilot Program.
The FDA has granted approval for Bizengri (zenocutuzumab-zbco), a drug designed to treat NRG1 fusion-positive cholangiocarcinoma, an ultra-rare and aggressive cancer. This approval represents the seventh under the National Priority Voucher Pilot Program.
Ascendis Pharma has ended the internal development of its IL-2 candidate. This decision signifies a pivot away from oncology expansion. The company had previously considered this asset for accelerated approval.
Ascendis Pharma has ended the internal development of its IL-2 candidate. This decision signifies a pivot away from oncology expansion. The company had previously considered this asset for accelerated approval.
fda_approval: selinexor — None