⚡ Top Events Today
Gossamer Bio stock plummets 80% after Phase 3 PROSERA trial failure, triggering lawsuit
The company announced the failure of its Phase 3 PROSERA trial, resulting in an immediate 80% drop in its stock price and the filing of a securities class action lawsuit.
BeOne Medicines wins accelerated FDA approval for BCL-2 inhibitor sonrotoclax in mantle cell lymphoma
The FDA granted accelerated approval for sonrotoclax for adult patients with r/r MCL after at least two lines of systemic therapy.
Alkermes' Lumryz meets all endpoints in Phase 3 study for a rare sleep disorder
The drug met all primary and key secondary endpoints in a pivotal Phase 3 study, demonstrating clinical success.
FDA approves Taiho Oncology's oral combination therapy for newly diagnosed AML
The FDA approved the oral combination for adults aged 75 or older, or those with comorbidities that preclude intensive induction chemotherapy.
Partner Therapeutics secures FDA approval for Bizengri in NRG1 fusion-positive cholangiocarcinoma
The drug was approved for adult patients who have progressed on or after prior systemic therapy.
📁 All Events (14364 stories)
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
Ipsen has discontinued two liver disease drug candidates that were acquired from Albireo in 2023. One of these assets has been entirely set aside following the $952 million acquisition of Albireo.
Ipsen has discontinued two liver disease drug candidates that were acquired from Albireo in 2023. One of these assets has been entirely set aside following the $952 million acquisition of Albireo.
The FDA granted regular approval to rucaparib (Rubraca) on December 17, 2025. This approval is for adults with deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with an androgen receptor-directed therapy.
The FDA granted regular approval to rucaparib (Rubraca) on December 17, 2025. This approval is for adults with deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with an androgen receptor-directed therapy.
The FDA granted accelerated approval to rucaparib for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.
The FDA granted accelerated approval to rucaparib for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer.
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo) from Eli Lilly and Company. This approval is for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation.
On September 27, 2024, the FDA granted traditional approval to selpercatinib (Retevmo) from Eli Lilly and Company. This approval is for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation.
The FDA's May docket includes at least five PDUFA dates for regulatory decisions. These decisions pertain to one new product submitted via the 505(b)(2) pathway and four label expansions for existing products.
The FDA's May docket includes at least five PDUFA dates for regulatory decisions. These decisions pertain to one new product submitted via the 505(b)(2) pathway and four label expansions for existing products.